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| ID | Type | Description | Link |
|---|---|---|---|
| 201609077 | Other Identifier | Washington University HRPO |
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| Name | Class |
|---|---|
| University of Maryland, Baltimore | OTHER |
| University of Colorado, Denver | OTHER |
| The University of Texas Medical Branch, Galveston | OTHER |
| Johns Hopkins University |
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This study is a randomized controlled double-blinded multi-center clinical trial enrolling female hip fracture patients who are 65 and older. It will compare the effects of six months of supervised exercise training combined with daily topical testosterone gel, to six months of supervised exercise and inactive gel, and to Enhanced Usual Care. The randomization protocol is that for every nine participants randomized, 4 will be assigned to the topical testosterone gel and supervised exercise training group; 4 will be assigned to topical inactive gel and supervised exercise training group; and 1 will be assigned to the enhanced usual care group. All participants will receive nutritional counseling, and calcium and vitamin D supplements.
Hip fractures are common among older women and can have a devastating impact on their ability to remain independent. A clinically important functional decline and failure to recover following a hip fracture has been documented as late as a year after the fracture, even among women who were functioning at high levels before the event. Age-associated androgen deficiency in women contributes to deficits in muscle mass, strength and power that are common in this patient population before the fracture, and are exacerbated afterward. A pilot study of testosterone (T) supplementation in elderly female hip fracture patients has demonstrated the feasibility of T treatment in this population, and showed gains in lean body mass (LBM) and muscle strength with active drug, compared to placebo. The benefits of exercise in restoring muscle strength and physical function after a hip fracture have been documented. However, it remains unclear whether T treatment can augment the effects of exercise on mobility and patient-reported function after hip fracture.
The STEP-HI study is a 3-group, multi-center, randomized, placebo-controlled, double-blinded, parallel group clinical trial in older female hip fracture patients. Between 120 and 168 female hip fracture patients, age 65 years and older, will be randomized from multiple clinical sites in the USA, using objective screening criteria for T deficiency (serum total testosterone level < 60 ng/dL) and physical frailty (Modified Physical Performance Test (PPT) Score of 12-28). The primary study aim is to compare supervised exercise training (EX) with inactive (placebo) gel (EX+P) and EX combined with T therapy (EX+T), to ascertain the incremental impact of adding T to EX in older adult women with a recent hip fracture. The study team will carefully monitor testosterone levels, adverse events, biochemical parameters, and factors related to adherence to the interventions.
Information from this study has the potential to alter treatment of hip fracture in older women, a problem that contributes to significant morbidity and mortality, and has a large public health impact. The STEP-HI study is highly aligned with NIA's mission of identifying interventions that target common geriatric conditions and improve treatment options for older adults with multiple morbidities or risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise + Testosterone (EX + T) | Experimental | Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression) daily, both for six months duration. |
|
| Exercise + Placebo (EX + P) | Placebo Comparator | Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. |
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| Enhanced Usual Care (EUC) | Other | Home exercise program 3 times per week and monthly health education modules, both for six months duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Topical testosterone gel 1% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Six Minute Walk Distance | Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. Each individual participant distance from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in walking distance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Lean Body Mass | Total lean body mass measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in total lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen F Binder, MD | Washington University School of Medicine | Principal Investigator |
| Kenneth B Schechtman, PhD | Washington University School of Medicine | Principal Investigator |
| Jay Magaziner, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Denver | Aurora | Colorado | 80045 | United States | ||
| University of Connecticut Heath - UConn Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33716173 | Background | Binder EF, Christensen JC, Stevens-Lapsley J, Bartley J, Berry SD, Dobs AS, Fortinsky RH, Hildreth KL, Kiel DP, Kuchel GA, Marcus RL, McDonough CM, Orwig D, Sinacore DR, Schwartz RS, Volpi E, Magaziner J, Schechtman KB. A multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemic. Contemp Clin Trials. 2021 May;104:106356. doi: 10.1016/j.cct.2021.106356. Epub 2021 Mar 11. | |
| 41624165 |
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4695 charts were reviewed. 907 were eligible by chart review and 344 agreed to complete the pre-screening questionnaire. Of those, 28 failed, another 42 were deemed ineligible after further review, 7 refused to review the consent, and 60 refused consent. Leaving 207 who consented for screening, of which 12 refused to continue to screening visit and 10 were found ineligible prior to screening. 185 screened, of whom 32 screen failed, 7 refused after screening, and 17 were ineligible to randomize.
Between August 2018 and February 2023, participants identified from hospital records or referred from physicians/rehabilitation staff at 8 academic medical centers, were approached 6-24 weeks following hip repair surgery. If eligible by chart review, participants were pre-screened, consented for full study, screened, and completed baseline assessments, prior to randomization. The first participant was randomized in March 2019 and the final participant randomized in February 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise + Testosterone (EX + T) | Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration. Testosterone: Topical testosterone gel 1% Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2022 |
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| OTHER |
| Harvard University | OTHER |
| University of Connecticut | OTHER |
| University of Utah | OTHER |
| University of Pittsburgh Medical Center | OTHER |
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Participants, investigators, and study staff conducting the interventions will be aware of the exercise group assignment. A Blinded Outcomes Assessor will be masked to study group assignment. Only the study pharmacist, an unblinded study physician, and Data Coordinating Center staff will be unblinded to gel treatment assignment.
| Placebo gel | Drug | Inactive skin gel |
|
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| Supervised exercise training | Behavioral | Multicomponent exercise program focused primarily on progressive resistance exercise training |
|
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| Home exercise program | Behavioral | Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. |
|
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| Health Education Modules | Behavioral | 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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| Baseline to 6 months |
| Change in Appendicular Lean Body Mass | Lean body mass of the arms and legs, measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in appendicular lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months. | Baseline to 6 months |
| Change in 1-repetition Maximum (1-RM) Leg Press Strength | Muscle strength measured as the maximal amount of weight that the participant was able to lift for one repetition (1-RM). The 1-RM is defined as the greatest resistance that could be overcome through a defined range of motion using proper techniques. Subjects were asked to move against progressively heavier resistance loads until a repetition failure was achieved. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent the increased ability to lift more weight. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Baseline to 6 months |
| Change in Total Modified Physical Performance Test (mPPT) Score | A modified version of the Physical Performance Test (mPPT) was used to measure physical function. Participants were asked to complete 9 standardized tasks (book lift, putting on a lab coat, picking up a penny from the floor, standing balance, standing up five times from a 16-inch chair, 50 foot walk including a turn, 360 degree turn, stair climb for 10 steps, and climbing 2 additional flights of steps) for a total score ranging from 0 (significant impairment) to 36 (excellent functioning). Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical functioning. | Baseline to 6 months |
| Change in Short Physical Performance Battery (SPPB) Score | The Short Physical Performance Battery (SPPB) is a well validated objective physical performance measure used to identify risk for disability. The SPPB consists of: chair rise, progressive Romberg balance, and 4 meter gait speed. Each task was scored (0-4) with a total range of 0-12. Participants who score 0 are unable to complete the tasks and participants with higher scores are considered to have higher functional mobility. Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical performance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Baseline to 6 months |
| Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire | The OARS Multidimensional Functional Assessment Questionnaire Activities of Daily Living (ADL) is a standardized, valid and reliable, self-report questionnaire used to determine the effect of services on the functional status of older adults by asking respondents about their ability to perform ADLS on 2 subscales: Basic (BADL) and Instrumental (IADL). Both subscales are scored from 0 (significant impairment) to 14 (excellent functioning). The individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in functioning. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Baseline to 6 months |
| Change in Functional Status Questionnaire (FSQ) Total Score | The Functional Status Questionnaire (FSQ) is a self-reported measure asking about the amount of difficulty a participant experienced when performing daily tasks in the previous 4 weeks. There are a total of 6 subscales, but only the basic ADL and Intermediate ADL were used in the STEP-HI study for a total of 9 items. Scores range from 0 (high amount of difficulty completing tasks) to 36 (no difficulty completing tasks). Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Baseline to 6 months |
| Change in Hip Rating Questionnaire Total Score | The Hip Rating Questionnaire (HRQ) Standardized is a 14-item scale with weighted questions regarding quality of life (pain level and ability to walk) and function (ability to use stairs, put on socks/shoes, use public transportation, bathe, shop, do housework, and get in and out of a chair/bed) related to the hip fracture event. The scale scores range from 16 to 100. Higher scores are associated with less pain, higher function, and better quality of life. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Baseline to 6 months |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health | Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health instrument is a 10 item self report questionnaire used to measure overall quality of life using 2 summary scores: Physical and Mental Health. Each summary score is standardized to the general population, with the average T-score for the US population being 50 and standard deviation of 10. Each individual participant T-score from Baseline was subtracted from Month 6 T-score to represent change over the length of the study. Higher scores represent larger increases in Physical and Mental Health. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Baseline to 6 months |
| Change in Bone Mineral Density (BMD) of the Non-fractured Proximal Femur | Bone mineral density (BMD) measured by dual x-ray absorptiometry (DXA) of the non-fractured proximal femur in participants without hardware in the contralateral hip. Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months. | Baseline to 6 months |
| Farmington |
| Connecticut |
| 06030 |
| United States |
| University of Maryland School of Medicine/Johns Hopkins University | Baltimore | Maryland | 21201 | United States |
| HebrewSenior Life Harvard Medical School | Roslindale | Massachusetts | 02131 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | United States |
| University of Texas Medical Branch at Galveston (UTMB) | Galveston | Texas | 77555 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Earp JE, Zhao S, Xu F, Kuo CL, Bartley JM, Fortinsky RH, Kositsawat J, Rehbein CO, Binder EF, Stevens-Lapsley J, Kuchel GA. Testosterone therapy effects adipose distribution in older females post hip-fracture: The STEP-HI study. Obes Pillars. 2026 Jan 12;17:100247. doi: 10.1016/j.obpill.2026.100247. eCollection 2026 Mar. |
| 40372752 | Derived | Binder EF, Bartley JM, Berry SD, Dore PM, Fisher SR, Fortinsky RH, Guild C, Kiel DP, Kuchel GA, Marcus RL, McDonough CM, Monroe KM, Orwig DL, Paluch RA, Reeds D, Stevens-Lapsley J, Volpi E, Schechtman KB, Magaziner JS. Combining Exercise Training and Testosterone Therapy in Older Women After Hip Fracture: The STEP-HI Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510512. doi: 10.1001/jamanetworkopen.2025.10512. |
| 36070134 | Derived | Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5. |
| FG001 |
| Exercise + Placebo (EX + P) |
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| FG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
| COMPLETED |
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| NOT COMPLETED |
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Randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise + Testosterone (EX + T) | Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration. Testosterone: Topical testosterone gel 1% Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| BG001 | Exercise + Placebo (EX + P) | Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| BG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Site | Count of Participants | Participants |
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| Time from hip surgery to baseline start date | Mean | Standard Deviation | days |
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| Type of Fracture | Count of Participants | Participants |
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| Body mass index (BMI) | Median | Standard Deviation | Kilograms/meters ^2 (kg/m^2) |
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| History of Lung Disease | Count of Participants | Participants |
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| Co-morbidity count | Individual co-morbidities from the STEP-HI Medical Health Questionnaire were counted giving each participant a score ranging from 0 to 38. A score of 0 represents no co-morbidities and a score of 38 represents having all counted diagnoses. | Mean | Standard Deviation | units on a scale |
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| Geriatric Depression Scale (GDS) | The Geriatric Depression Scale short form is a standardized, self-report measure of depression validated for older adults. The scale contains 15 yes or no items. Scores range from 0 to 15. Scores of 0 to 5 are considered normal, while scores greater than 5 suggest depression. The higher the score, the more severe the depression. | Mean | Standard Deviation | unites on a scale |
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| Six Minute Walk Distance | Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. | Mean | Standard Deviation | meters |
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| Total lean body mass | Total lean body mass measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. | Mean | Standard Deviation | Grams |
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| Appendicular lean body mass | Lean body mass of the arms and legs, measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. | Mean | Standard Deviation | Grams |
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| Leg Press 1-Repetition Maximum | Muscle strength measured as the maximal amount of weight that the participant was able to lift for one repetition (1-RM). The 1-RM is defined as the greatest resistance that could be overcome through a defined range of motion using proper techniques. 1-RM was obtained using the fractured and unfractured legs simultaneously, on identical inclined leg press machines (Inflight model CT-ILPC) across clinical sites. Subjects were asked to move against progressively heavier resistance loads until a repetition failure was achieved. A rest period separated each increase in weight. | 7 participants attempted, but were unable to complete the 1-RM (unable to move the weight at all) and 2 participants refused to attempt the measure. | Mean | Standard Deviation | Pounds |
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| Modified Physical Performance (mPPT) Score | A modified version of the Physical Performance Test (mPPT) was used to measure physical function. Participants were asked to complete 9 standardized tasks (book lift, putting on a lab coat, picking up a penny from the floor, standing balance, standing up five times from a 16-inch chair, 50 foot walk including a turn, 360 degree turn, stair climb for 10 steps, and climbing 2 additional flights of steps) for a total score ranging from 0 (significant impairment) to 36 (excellent functioning). | Mean | Standard Deviation | units on a scale |
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| Short Physical Performance Battery (SPPB) | The Short Physical Performance Battery (SPPB) is a well validated objective physical performance measure used to identify risk for disability. The SPPB consists of 3 tasks: chair rise, progressive Romberg balance, and gait speed on a 4 meter walk (both at preferred normal speed and fast pace). Each task was scored (0-4) with a total range of 0 to 12. Participants who score 0 are unable to complete the tasks and participants with higher scores are considered to have higher functional mobility. | Mean | Standard Deviation | units on a scale |
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| Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire | The Duke Older Adult Resources and Services (OARS) Multidimensional Functional Assessment Questionnaire complete Activities of Daily Living (ADL) is a standardized, valid and reliable, self-report questionnaire used to determine the effect of services on the functional status of older adults. The respondents were asked about their ability to perform basic (BADL) and instrumental (IADL) activities of daily living. The OARS basic and instrumental ALD subscales are both measured by 7 questions with scores from 0 (meaning significant impairment) to 14 (meaning excellent functioning). | Mean | Standard Deviation | units on a scale |
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| Functional Status Questionnaire (FSQ) | The Functional Status Questionnaire (FSQ) is a self-reported measure asking about the amount of difficulty a participant experienced when performing daily tasks in the previous 4 weeks. There are a total of 6 subscales, but only the basic ADL and Intermediate ADL were used in the STEP-HI study for a total of 9 items. Scores range from 0 (high amount of difficulty completing tasks) to 36 (no difficulty completing tasks). | Mean | Standard Deviation | units on a scale |
| |||||||||
| Hip Rating Questionnaire (HRQ) | The Hip Rating Questionnaire (HRQ) Standardized is a 14-item scale with weighted questions regarding quality of life (pain level and ability to walk) and function (ability to use stairs, put on socks/shoes, use public transportation, bathe, shop, do housework, and get in and out of a chair/bed) related to the hip fracture event. The scale scores range from 16 to 100. Higher scores are associated with less pain, higher function, and better quality of life. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Bone mineral density (BMD) of non-fractured proximal femur | Bone mineral density (BMD) measured by dual x-ray absorptiometry (DXA) of the non-fractured proximal femur in participants without hardware in the contralateral hip. Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. | Only participants without hardware in their contralateral hip (opposite hip to the surgical repair conducted just prior to enrollment in the STEP-HI study) completed the DXA scan for BMD. A total of 9 EX+T, 6 EX+P, and 4 EUC participants were not scanned. | Mean | Standard Deviation | Grams/centimeters^2 (g/cm^2) |
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| Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health | Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health instrument is a 10 item self report questionnaire used to measure overall quality of life using 2 summary scores: physical and mental health. PROMIS® Global Health was developed and validated to be psychometrically accurate for the general population, as well as individuals with chronic conditions. Each summary score is standardized to the general population, with the average T-score for the US population being 50 and standard deviation of 10. Higher scores represent better global health. | Mean | Standard Deviation | T-score |
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| Serum Testosterone Level (Total) | Serum total testosterone as measured by liquid chromatography - tandem mass spectrometry (LC-MS) test methodology. Total testosterone levels under 7.0 ng/dL are not detectable. In these cases, 6.9 was used in place of a missing value. | Mean | Standard Deviation | nanograms per deciliter (ng/dL) |
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| Serum Testosterone Level (Free) | Serum free testosterone as measured by liquid chromatography - tandem mass spectrometry (LC-MS) test methodology. The lowest value of free testosterone which was detectable was 1.12. Lab reports with undetectably low values were set to 1.12. | The central lab was unable to process free testosterone for certain periods due to equipment failure. The measurement was obtained if possible. | Mean | Standard Deviation | nanograms per deciliter (ng/dL) |
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| Hand grip strength - left hand | Hand grip strength measured by hand dynamometer to obtain the average of 3 trials. | One participant was unable to preform the hand grip in the left hand. | Mean | Standard Deviation | Kilograms (kg) |
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| Hand grip strength - right hand | Hand grip strength measured by hand dynamometer to obtain the average of 3 trials. | Mean | Standard Deviation | Kilograms (kg) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Six Minute Walk Distance | Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. Each individual participant distance from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in walking distance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | Meters | Baseline to 6 months |
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| Secondary | Change in Total Lean Body Mass | Total lean body mass measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in total lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | grams | Baseline to 6 months |
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| Secondary | Change in Appendicular Lean Body Mass | Lean body mass of the arms and legs, measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in appendicular lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | grams | Baseline to 6 months |
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| Secondary | Change in 1-repetition Maximum (1-RM) Leg Press Strength | Muscle strength measured as the maximal amount of weight that the participant was able to lift for one repetition (1-RM). The 1-RM is defined as the greatest resistance that could be overcome through a defined range of motion using proper techniques. Subjects were asked to move against progressively heavier resistance loads until a repetition failure was achieved. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent the increased ability to lift more weight. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | pounds | Baseline to 6 months |
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| Secondary | Change in Total Modified Physical Performance Test (mPPT) Score | A modified version of the Physical Performance Test (mPPT) was used to measure physical function. Participants were asked to complete 9 standardized tasks (book lift, putting on a lab coat, picking up a penny from the floor, standing balance, standing up five times from a 16-inch chair, 50 foot walk including a turn, 360 degree turn, stair climb for 10 steps, and climbing 2 additional flights of steps) for a total score ranging from 0 (significant impairment) to 36 (excellent functioning). Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical functioning. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 6 months |
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| Secondary | Change in Short Physical Performance Battery (SPPB) Score | The Short Physical Performance Battery (SPPB) is a well validated objective physical performance measure used to identify risk for disability. The SPPB consists of: chair rise, progressive Romberg balance, and 4 meter gait speed. Each task was scored (0-4) with a total range of 0-12. Participants who score 0 are unable to complete the tasks and participants with higher scores are considered to have higher functional mobility. Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical performance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 6 months |
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| Secondary | Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire | The OARS Multidimensional Functional Assessment Questionnaire Activities of Daily Living (ADL) is a standardized, valid and reliable, self-report questionnaire used to determine the effect of services on the functional status of older adults by asking respondents about their ability to perform ADLS on 2 subscales: Basic (BADL) and Instrumental (IADL). Both subscales are scored from 0 (significant impairment) to 14 (excellent functioning). The individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in functioning. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 6 months |
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| Secondary | Change in Functional Status Questionnaire (FSQ) Total Score | The Functional Status Questionnaire (FSQ) is a self-reported measure asking about the amount of difficulty a participant experienced when performing daily tasks in the previous 4 weeks. There are a total of 6 subscales, but only the basic ADL and Intermediate ADL were used in the STEP-HI study for a total of 9 items. Scores range from 0 (high amount of difficulty completing tasks) to 36 (no difficulty completing tasks). Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 6 months |
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| Secondary | Change in Hip Rating Questionnaire Total Score | The Hip Rating Questionnaire (HRQ) Standardized is a 14-item scale with weighted questions regarding quality of life (pain level and ability to walk) and function (ability to use stairs, put on socks/shoes, use public transportation, bathe, shop, do housework, and get in and out of a chair/bed) related to the hip fracture event. The scale scores range from 16 to 100. Higher scores are associated with less pain, higher function, and better quality of life. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 6 months |
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| Secondary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health | Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health instrument is a 10 item self report questionnaire used to measure overall quality of life using 2 summary scores: Physical and Mental Health. Each summary score is standardized to the general population, with the average T-score for the US population being 50 and standard deviation of 10. Each individual participant T-score from Baseline was subtracted from Month 6 T-score to represent change over the length of the study. Higher scores represent larger increases in Physical and Mental Health. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | T-score | Baseline to 6 months |
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| Secondary | Change in Bone Mineral Density (BMD) of the Non-fractured Proximal Femur | Bone mineral density (BMD) measured by dual x-ray absorptiometry (DXA) of the non-fractured proximal femur in participants without hardware in the contralateral hip. Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months. | Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization). | Posted | Least Squares Mean | 95% Confidence Interval | g/cm^2 | Baseline to 6 months |
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Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise + Testosterone (EX + T) | Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration. Testosterone: Topical testosterone gel 1% Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training | 1 | 55 | 7 | 54 | 36 | 54 |
| EG001 | Exercise + Placebo (EX + P) | Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training | 0 | 54 | 3 | 55 | 24 | 55 |
| EG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. | 0 | 20 | 1 | 20 | 11 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Ruptured diverticulum of colon | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment | Large intestine perforation |
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| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Kidney fibrosis | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment | Renal scarring |
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| Medical device complication | General disorders | MedDRA (18.1) | Systematic Assessment | Loosening of stabilization hardware of hip fracture repair |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | Buttock pain |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment | Sigmoid diverticulosis |
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| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.1) | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Vomiting bile | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Edema | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Edema peripheral | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Blood Calcium increased | Investigations | MedDRA (18.1) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (18.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | 2 additional participants complained of arthralgia after screening, but did not randomize. |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | One additional participant complained of back pain after screening, but did not randomize. |
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| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | Bunion |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Scab | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen F. Binder, Professor of Medicine and Occupational Therapy | Washington University in St. Louis School of Medicine | 314-286-2707 | ebinder@wustl.edu |
| Jun 25, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2023 | Sep 27, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
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| Instrumental Activities of Daily Living (IADL) |
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| Physical Health T-score |
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| Baseline to 6 month with covariates |
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| Unadjusted baseline to 3 months |
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| Baseline to 3 months with covariates |
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| Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure. | Mixed Models Analysis | t (df, 112) = 0.30 | 0.767 | Unadjusted p-value | Mean Difference (Final Values) | 5.04 | 2-Sided | 95 | -28.57 | 38.65 | Difference between the changes (EX+T - EUC) | Superiority |
| Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure. | Mixed Models Analysis | t (df,112) = 0.17 | 0.868 | Unadjusted p-value | Mean Difference (Final Values) | 2.84 | 2-Sided | 95 | -30.93 | 36.62 | Difference between the changes (EX+P - EUC) | Superiority |
| Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates. | Mixed Models Analysis | t (df, 217) = 0.05 | 0.960 | Unadjusted p-value | Mean Difference (Final Values) | 0.63 | 2-Sided | 95 | -24.26 | 25.52 | Difference between the changes (EX+T - EX+P) | Superiority |
| Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates. | Mixed Models Analysis | t (df, 217) = 0.48 | 0.630 | Unadjusted p-value | Mean Difference (Final Values) | 8.42 | 2-Sided | 95 | -25.97 | 42.82 | Difference between the changes (EX+T - EUC) | Superiority |
| Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates. | Mixed Models Analysis | t (df, 217) = 0.44 | 0.657 | Unadjusted p-value | Mean Difference (Final Values) | 7.79 | 2-Sided | 95 | -26.77 | 42.36 | Difference between the changes (EX+P - EUC) | Superiority |
| Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure. | Mixed Models Analysis | t (df, 112) = -0.49 | 0.627 | Unadjusted p-value | Mean Difference (Final Values) | -5.08 | 2-Sided | 95 | -25.72 | 15.56 | Difference between the changes (EX+T - EX+P) | Superiority |
| Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure. | Mixed Models Analysis | t (df, 112) = -0.91 | 0.364 | Unadjusted p-value | Mean Difference (Final Values) | -13.50 | 2-Sided | 95 | -42.86 | 15.86 | Difference between the changes (EX+T - EUC) | Superiority |
| Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure. | Mixed Models Analysis | t (df, 112) = -0.56 | 0.574 | Unadjusted p-value | Mean Difference (Final Values) | -8.42 | 2-Sided | 95 | -38.00 | 21.15 | Difference between the changes (EX+P - EUC) | Superiority |
| Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates. | Mixed Models Analysis | t (df, 217) = -0.59 | 0.557 | Unadjusted p-value | Mean Difference (Final Values) | -5.51 | 2-Sided | 95 | -23.96 | 12.94 | Difference between the changes (EX+T - EX+P) | Superiority |
| Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates. | Mixed Models Analysis | t (df, 217) = -1.03 | 0.302 | Unadjusted p-value | Mean Difference (Final Values) | -13.65 | 2-Sided | 95 | -39.64 | 12.35 | Difference between the changes (EX+T - EUC) | Superiority |
| Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates. | Mixed Models Analysis | t (df, 217) = -0.61 | 0.541 | Unadjusted p-value | Mean Difference (Final Values) | -8.14 | 2-Sided | 95 | -34.33 | 18.06 | Difference between the changes (EX+P - EUC) | Superiority |
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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| OG001 |
| Exercise + Placebo (EX + P) |
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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| OG001 | Exercise + Placebo (EX + P) | Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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| OG001 | Exercise + Placebo (EX + P) | Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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| OG001 | Exercise + Placebo (EX + P) | Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Placebo gel: Inactive skin gel Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training |
| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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| OG002 | Enhanced Usual Care (EUC) | Home exercise program 3 times per week and monthly health education modules, both for six months duration. Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
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