Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study to assess the feasibility, acceptability, and safety of a personalized exercise training program adapted from Gerofit to improve physical health and quality of life for adults with SCD
The purpose of this study is to adapt and pilot the Gerofit personalized exercise intervention for older adults with sickle cell disease (age ≥ 40 years). The Sickle Cell Disease Functional Assessment (SCD-FA) will be performed at steady state at baseline and every 3 months to track progress. Endpoints include feasibility, acceptability, and safety. All participants will be interviewed to identify barriers and facilitators to exercise and how to better optimize the exercise intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gerofit Exercise Program | Behavioral | The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events | Number of participants with one or more moderate or severe adverse events within 48 hours after each exercise session. | 12 weeks |
| Acceptability, as Measured by the Number of Participants Reporting the Intervention as Acceptable |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Clinically Meaningful Change in Mobility as Measured by Usual Gait Speed | Reported as the percent change in usual walking speed on a 4.57 meter (15 feet) walking course. | Baseline, 24 weeks |
| Percent of Participants With Clinically Meaningful Change in Balance as Measured by Timed Up and Go |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charity I Oyedeji, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29430642 | Background | Morey MC, Lee CC, Castle S, Valencia WM, Katzel L, Giffuni J, Kopp T, Cammarata H, McDonald M, Oursler KA, Wamsley T, Jain C, Bettger JP, Pearson M, Manning KM, Intrator O, Veazie P, Sloane R, Li J, Parker DC. Should Structured Exercise Be Promoted As a Model of Care? Dissemination of the Department of Veterans Affairs Gerofit Program. J Am Geriatr Soc. 2018 May;66(5):1009-1016. doi: 10.1111/jgs.15276. Epub 2018 Feb 12. | |
| 35246265 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
One participant was withdrawn by the PI due to weekly hospitalizations and never started the program. Two participants consented but never completed the safety orientation and never started the program. Both cited a busy schedule and inability to make the time commitment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Feasibility, as Measured by Number of Participants Completing at Least 50% of the Exercise Sessions | Posted | Count of Participants | Participants | 12 weeks |
|
Up to 24 weeks
Not provided
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 | Each cohort of 5-8 participants will exercise 3 days a week for up to 12 weeks. Exercise sessions will be virtual. The tele-Gerofit exercise intervention has training focused on meeting the physical activity guidelines and incorporating cardiovascular, strength, and balance training. Sessions will also include a mindfulness component, warm up, cool-down, and safety checks. Exercises are personalized to each person's functional status. Intensity of exercises will be determined by participants providing a rating of perceived exertion (RPE) on a scale of 0 (easy) to 10 (very hard) throughout the session. Initial exercise sessions will start at low-intensity and will gradually increase the duration and intensity to allow each person to reach recommended exercise levels at their own pace. Exercises are done virtually via Zoom. Each cohort will have 5-8 participants. The exercise program will be optimized after each cohort with modifications based on participant and exercise expert feedback. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle Cell Pain Crisis | Blood and lymphatic system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charity Oyedeji, MD | Duke University | (919) 684-0628 | Charity.Oyedeji@duke.edu |
Not provided
| 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 | Aug 20, 2024 | May 5, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2025 | Jun 29, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Acceptability of the exercise program was measured on a scale of 1-10, where 1= severe dislike and 10 = absolute enjoyment. Reported as the number of participants with scores of 8-10. |
| 12 weeks |
Performance test of physical mobility. This measures the number of seconds it takes to stand up from a standard chair (46cm), walk a distance of 10 ft (3 meters), turn back to the chair, and sit down again. |
| Baseline, 12-24 weeks |
| Percent of Participants With Clinically Meaningful Change in Aerobic Endurance as Measured by Six-Minute Walk Test (6MWT) | Measure of aerobic endurance. The participant walks as fast and as safely as possible for 6 minutes with prompts given every minute. Distance traveled in 6 minutes is recorded. | Baseline, 12-24 weeks |
| Percent of Participants With Clinically Meaningful Change in Upper Body Strength as Measured by Grip Strength | Measure of upper body strength. Jamar hydraulic hand dynamometer (Jamar Technologies) was used to measure grip strength in triplicate for both hands while subject remains seated. The greatest value was used in analysis. | Baseline, 12-24 weeks |
| Percent of Participants With Clinically Meaningful Change in Lower Body Strength as Measured by 30-second Chair Stand | 30-second chair stand is a measure lower body strength. The participant sits in a folding chair without arms with chair pressed against the wall and stands up and sits back down with arms across their chest as many times as possible in 30 seconds. | Baseline, 12-24 weeks |
| Percent of Participants With Improved Quality of Movement Measured by Functional Movement Screen | Includes deep squat and mobility test of upper and lower extremities. This is measure of squat quality/form. | Baseline, 12-24 weeks |
| Background |
| Oyedeji CI, Hall K, Luciano A, Morey MC, Strouse JJ. The Sickle Cell Disease Functional Assessment (SCD-FA) tool: a feasibility pilot study. Pilot Feasibility Stud. 2022 Mar 4;8(1):53. doi: 10.1186/s40814-022-01005-3. |
| 12473002 | Background | Morey MC, Pieper CF, Crowley GM, Sullivan RJ, Puglisi CM. Exercise adherence and 10-year mortality in chronically ill older adults. J Am Geriatr Soc. 2002 Dec;50(12):1929-33. doi: 10.1046/j.1532-5415.2002.50602.x. |
| 2921457 | Background | Morey MC, Cowper PA, Feussner JR, DiPasquale RC, Crowley GM, Kitzman DW, Sullivan RJ Jr. Evaluation of a supervised exercise program in a geriatric population. J Am Geriatr Soc. 1989 Apr;37(4):348-54. doi: 10.1111/j.1532-5415.1989.tb05503.x. |
| 30663090 | Background | Oyedeji C, Strouse JJ, Crawford RD, Garrett ME, Ashley-Koch AE, Telen MJ. A multi-institutional comparison of younger and older adults with sickle cell disease. Am J Hematol. 2019 Apr;94(4):E115-E117. doi: 10.1002/ajh.25405. Epub 2019 Jan 31. No abstract available. |
| 30504341 | Background | Liem RI. Balancing exercise risk and benefits: lessons learned from sickle cell trait and sickle cell anemia. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):418-425. doi: 10.1182/asheducation-2018.1.418. |
| 31742587 | Background | Merlet AN, Messonnier LA, Coudy-Gandilhon C, Bechet D, Gellen B, Rupp T, Galacteros F, Bartolucci P, Feasson L. Beneficial effects of endurance exercise training on skeletal muscle microvasculature in sickle cell disease patients. Blood. 2019 Dec 19;134(25):2233-2241. doi: 10.1182/blood.2019001055. |
| 28598539 | Background | Liem RI, Akinosun M, Muntz DS, Thompson AA. Feasibility and safety of home exercise training in children with sickle cell anemia. Pediatr Blood Cancer. 2017 Dec;64(12). doi: 10.1002/pbc.26671. Epub 2017 Jun 9. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Safety, as Measured by Number of Participants With Moderate or Severe Adverse Events | Number of participants with one or more moderate or severe adverse events within 48 hours after each exercise session. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Acceptability, as Measured by the Number of Participants Reporting the Intervention as Acceptable | Acceptability of the exercise program was measured on a scale of 1-10, where 1= severe dislike and 10 = absolute enjoyment. Reported as the number of participants with scores of 8-10. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Percent of Participants With Clinically Meaningful Change in Mobility as Measured by Usual Gait Speed | Reported as the percent change in usual walking speed on a 4.57 meter (15 feet) walking course. | Four participants did not present for post-physical assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 24 weeks |
|
|
|
| Other Pre-specified | Percent of Participants With Clinically Meaningful Change in Balance as Measured by Timed Up and Go | Performance test of physical mobility. This measures the number of seconds it takes to stand up from a standard chair (46cm), walk a distance of 10 ft (3 meters), turn back to the chair, and sit down again. | Four participants did not present for post-physical assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 12-24 weeks |
|
|
|
| Other Pre-specified | Percent of Participants With Clinically Meaningful Change in Aerobic Endurance as Measured by Six-Minute Walk Test (6MWT) | Measure of aerobic endurance. The participant walks as fast and as safely as possible for 6 minutes with prompts given every minute. Distance traveled in 6 minutes is recorded. | One participant did not complete baseline 6MWT. Four participants did not present for post-physical assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 12-24 weeks |
|
|
|
| Other Pre-specified | Percent of Participants With Clinically Meaningful Change in Upper Body Strength as Measured by Grip Strength | Measure of upper body strength. Jamar hydraulic hand dynamometer (Jamar Technologies) was used to measure grip strength in triplicate for both hands while subject remains seated. The greatest value was used in analysis. | Four participants did not present for post-physical assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 12-24 weeks |
|
|
|
| Other Pre-specified | Percent of Participants With Clinically Meaningful Change in Lower Body Strength as Measured by 30-second Chair Stand | 30-second chair stand is a measure lower body strength. The participant sits in a folding chair without arms with chair pressed against the wall and stands up and sits back down with arms across their chest as many times as possible in 30 seconds. | Four participants did not present for post-physical assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 12-24 weeks |
|
|
|
| Other Pre-specified | Percent of Participants With Improved Quality of Movement Measured by Functional Movement Screen | Includes deep squat and mobility test of upper and lower extremities. This is measure of squat quality/form. | Four participants did not present for post-physical assessment. | Posted | Number | percentage of participants | Baseline, 12-24 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 3 |
| 30 |
Not provided
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |