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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR010904-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of the Staying Active with Arthritis (STAR) research study is to determine if a 6-month program will improve leg exercise, fitness walking, and clinical outcomes (function, blood pressure, leg strength, pain, fatigue, and health-related quality of life) in older adults with osteoarthritis of the knee and high blood pressure.
Over 9 million Americans have symptomatic osteoarthritis (OA) of the knee, a chronic disease associated with frequent joint pain, functional limitations, and quadriceps weakness that intrude upon everyday life. At least half of those with OA of the knee are diagnosed with hypertension or high blood pressure (HBP), one of the most prevalent risk factors for cardiovascular disease. Many other individuals with OA of the knee unknowingly have HBP and remain untreated. Our own work and that of others suggest that persons with OA of the knee experience reductions in BP when they participate in a regular regimen of physical activity. Even small decreases in systolic and diastolic BP found with physical activity are clinically significant, e.g., a 2 mm Hg decrease reduces the risk of stroke by 14% - 17%, and the risk of coronary heart disease is reduced by 6% - 9%. Yet, only 15% of persons with OA and 47% with HBP engage in regular physical activity. The purpose of this study is to investigate how the individually delivered, home-based, 6-month modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid HBP, affects lower extremity exercise (flexibility, strengthening, and balance), fitness walking, functional status, BP, quadriceps strength, pain, fatigue, and health-related quality of life (HRQoL) in a convenience sample of 224 adults age 50 years or older with OA of the knee and HBP. Using a randomized controlled, 2-group design, we (1) hypothesize that at the end of the 6-month intervention period and 6 months after the intervention period ends those who receive the modified STAR intervention will be more likely to perform lower extremity exercise, participate in fitness walking, show improvements in objective functional status, and demonstrate reductions in BP than those who receive attention-control. Secondarily, we will (2) evaluate the impact of the modified STAR intervention, compared to attention-control, on subjective functional status, quadriceps strength, pain, fatigue, and HRQoL at both time points; (3) explore the impact of the modified STAR intervention, compared to attention-control, on self-efficacy and outcome expectancy at both time points; (4) explore the relationship between self-efficacy and outcome expectancy; and (5) explore the extent to which self-efficacy and outcome expectancy mediate the relationship between the modified STAR intervention and performance of lower extremity exercise and participation in fitness walking. Data will be analyzed using repeated measures modeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAR Intervention | Experimental | Staying Active with Arthritis Intervention |
|
| Attention-Control | Placebo Comparator | Senior Health Information Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR Intervention | Behavioral | The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of Lower Extremity Exercise at 25 Weeks | Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the participant reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period). | At the end of the 6-month intervention period (week 25) |
| Participation in Fitness Walking at 25 Weeks | Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period. | At the end of the 6-month intervention period (week 25) |
| Objective Functional Status by the 6-minute Walk at 25 Weeks | Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment. | At the end of the 6-month intervention period (week 25) |
| Objective Functional Status by the Short Physical Performance Battery at 25 Weeks | Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better. | At the end of the 6-month intervention period (week 25) |
| Systolic Blood Pressure at 25 Weeks | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. | At the end of the 6-month intervention period (week 25) |
| Diastolic Blood Pressure at 25 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Functional Status at 25 Weeks | Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better. | At the end of the 6-month intervention period (week 25) |
| Quadriceps Strength at 25 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A. Schlenk, PhD, RN | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh School of Nursing | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33039202 | Derived | Schlenk EA, Sereika SM, Martire LM, Shi X. Older adults' social network and support and its association with physical activity. Geriatr Nurs. 2021 Mar-Apr;42(2):517-523. doi: 10.1016/j.gerinurse.2020.09.006. Epub 2020 Oct 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | STAR Intervention | Staying Active with Arthritis Intervention STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. |
| FG001 | Attention-Control | Senior Health Information Intervention Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | STAR Intervention | Staying Active with Arthritis Intervention STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. |
| 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 | Performance of Lower Extremity Exercise at 25 Weeks | Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the participant reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period). | Posted | Mean | Standard Error | repetitions x sets/week | At the end of the 6-month intervention period (week 25) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STAR Intervention | Staying Active with Arthritis Intervention STAR Intervention: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth A. Schlenk | University of Pittsburgh | 412-624-4103 | els100@pitt.edu |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D006973 | Hypertension |
| D009043 | Motor Activity |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Attention-Control | Behavioral | Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. |
|
Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
| At the end of the 6-month intervention period (week 25) |
| Performance of Lower Extremity Exercise at 52 Weeks | Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the subject reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period). | 6 months after the intervention period ends (week 52) |
| Participation in Fitness Walking at 52 Weeks | Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period. | 6 months after the intervention period ends (week 52) |
| Objective Functional Status by the 6-minute Walk at 52 Weeks | Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment. | 6 months after the intervention period ends (week 52) |
| Objective Functional Status by the Short Physical Performance Battery at 52 Weeks | Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better. | 6 months after the intervention period ends (week 52) |
| Systolic Blood Pressure at 52 Weeks | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. | 6 months after the intervention period ends (week 52) |
| Diastolic Blood Pressure at 52 Weeks | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. | 6 months after the intervention period ends (week 52) |
Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials. |
| At the end of the 6-month intervention period (week 25) |
| Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks | Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better. | At the end of the 6-month intervention period (week 25) |
| Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks | Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better. | At the end of the 6-month intervention period (week 25) |
| Fatigue at 25 Weeks | Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better. | At the end of the 6-month intervention period (week 25) |
| Health-Related Quality of Life at 25 Weeks | Measured by the Short Form-36v2 in terms of the following: Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better | At the end of the 6-month intervention period (week 25) |
| Self-Efficacy at 25 Weeks | Measured by the Self-Efficacy Scale in terms of the following: Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better | At the end of the 6-month intervention period (week 25) |
| Arthritis Self-Efficacy at 25 Weeks | Measured by the Arthritis Self-Efficacy Scale in terms of the following: Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better | At the end of the 6-month intervention period (week 25) |
| Outcome Expectancy at 25 Weeks | Measured by the Perceived Therapeutic Efficacy Scale in terms of the following: Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better | At the end of the 6-month intervention period (week 25) |
| Subjective Functional Status at 52 Weeks | Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better. | 6 months after the intervention period ends (week 52) |
| Quadriceps Strength at 52 Weeks | Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials. | 6 months after the intervention period ends (week 52) |
| Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks | Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better. | 6 months after the intervention period ends (week 52) |
| Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks | Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better. | 6 months after the intervention period ends (week 52) |
| Fatigue at 52 Weeks | Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better. | 6 months after the intervention period ends (week 52) |
| Health-Related Quality of Life at 52 Weeks | Measured by the Short Form-36v2 in terms of the following: Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better | 6 months after the intervention period ends (week 52) |
| Self-Efficacy at 52 Weeks | Measured by the Self-Efficacy Scale in terms of the following: Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better | 6 months after the intervention period ends (week 52) |
| Arthritis Self-Efficacy at 52 Weeks | Measured by the Arthritis Self-Efficacy Scale in terms of the following: Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better | 6 months after the intervention period ends (week 52) |
| Outcome Expectancy at 52 Weeks | Measured by the Perceived Therapeutic Efficacy Scale in terms of the following: Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better | 6 months after the intervention period ends (week 52) |
| BG001 | Attention-Control | Senior Health Information Intervention Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m² |
|
| Number of comorbidities | Mean | Standard Deviation | comorbidities |
|
| Marital status | Number | participants |
|
| Educational status | Number | participants |
|
| Employment status | Number | participants |
|
| Household income | Number | participants |
|
| Lower extremity exercise (e-diary): days/week | Mean | Standard Deviation | days/week |
|
| Lower extremity exercise (e-diary): minutes/week | Mean | Standard Deviation | minutes/week |
|
| Lower extremity exercise (e-diary): average minutes/day | Mean | Standard Deviation | average minutes/day |
|
| Lower extremity exercise (e-diary): volume [repetitions x sets over 7-day period]/week | Mean | Standard Deviation | repetitions x sets/week |
|
| Fitness walking (e-dairy): days/week | Mean | Standard Deviation | days/week |
|
| Fitness walking (e-diary): minutes/week | Mean | Standard Deviation | minutes/week |
|
| Fitness walking (e-diary): average minutes/day | Mean | Standard Deviation | average minutes/day |
|
| Activity minutes over 7 days (ActiGraph): no to very low (counts of 0-99/min) | Mean | Standard Deviation | minutes |
|
| Activity minutes over 7 days (ActiGraph): light (counts of 100-2,019/min) | Mean | Standard Deviation | minutes |
|
| Activity minutes over 7 days (ActiGraph): moderate-to-vigorous (counts of > 2,020/min) | Mean | Standard Deviation | minutes |
|
| Number of bouts over 7 days (ActiGraph): bouts of moderate-to-vigorous activity | Mean | Standard Deviation | bouts |
|
| Mean duration of bouts over 7 days (ActiGraph): bouts of moderate-to-vigorous activity n=96 | Some participants in each group had no bouts at baseline of => 10 consecutive minutes participating in activity at the => 2,020 counts threshold. | Mean | Standard Deviation | minutes |
|
| Mean number of daily activity minutes (ActiGraph): no to very low (counts of 0-99/min) | Mean | Standard Deviation | minutes |
|
| Mean number of daily activity minutes (ActiGraph): light (counts of 100-2,019/min) | Mean | Standard Deviation | minutes |
|
| Mean number of daily activity minutes (ActiGraph): moderate-to-vigorous (counts of >2,020/min) | Mean | Standard Deviation | minutes |
|
| Mean number of daily bouts (ActiGraph): bouts of moderate-to-vigorous activity | Mean | Standard Deviation | bouts |
|
| Systolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| 6-minute walk | Mean | Standard Deviation | yards |
|
| Short Physical Performance Battery: total | Subscale scores are summed for a total scale score; the total scale score range is 0-13; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Short Physical Performance Battery: repeated chair stands | The repeated chair stands subscale score range is 0-4; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Short Physical Performance Battery: 4-meter usual walk | The 4-meter usual walk subscale score range is 0-4; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Short Physical Performance Battery: standing balance | The standing balance subscale score range is 0-5; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Chair sit-and-reach | Mean | Standard Deviation | inches |
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| 8-foot up-and-go | Mean | Standard Deviation | seconds |
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| Quadriceps strength (mean maximum for right and left quadriceps) | Mean | Standard Deviation | pounds |
|
| Western Ontario and McMaster Universities Osteoarthritis Index: Pain | The WOMAC Osteoarthritis Index Pain subscale score range is 0-20; lower scores are better | Mean | Standard Deviation | units on a scale |
|
| Western Ontario and McMaster Universities Osteoarthritis Index: Function | The WOMAC Osteoarthritis Index Function subscale score range is 0-68; lower scores are better | Mean | Standard Deviation | units on a scale |
|
| Western Ontario and McMaster Universities Osteoarthritis Index: Stiffness | The WOMAC Osteoarthritis Index Stiffness subscale score range is 0-8; lower scores are better | Mean | Standard Deviation | units on a scale |
|
| Short Form-36v2 Health Survey: Bodily Pain | The subscale score range is 0-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Short Form-36v2 Health Survey: Physical Functioning | The subscale score range is 0-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Short Form-36v2 Health Survey: Physical Component Score | This summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Short Form-36v2 Health Survey: Mental Component Score | This summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Brief Fatigue Inventory | The scale score range is 0-10; lower scores are better | Mean | Standard Deviation | units on a scale |
|
| Self-efficacy: Exercise | The subscale score range is 0-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Self-efficacy: Exercise Barriers | The subscale score range is 0-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Self-efficacy: Arthritis Pain | The subscale score range is 10-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Self-efficacy: Arthritis Function | The subscale score range is 10-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Self-efficacy: Arthritis Other Symptoms | The subscale score range is 10-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Perceived Therapeutic Efficacy - Exercise & Arthritis | The PTE Exercise & Arthritis scale score range is 0-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| Perceived Therapeutic Efficacy - Exercise & Hypertension | The PTE Exercise & Hypertension scale score range is 0-100; higher scores are better | Mean | Standard Deviation | units on a scale |
|
| OG001 | Attention-Control | Senior Health Information Intervention Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. |
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| Primary | Participation in Fitness Walking at 25 Weeks | Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period. | Posted | Mean | Standard Error | minutes | At the end of the 6-month intervention period (week 25) |
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| Primary | Objective Functional Status by the 6-minute Walk at 25 Weeks | Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment. | Posted | Mean | Standard Error | yards | At the end of the 6-month intervention period (week 25) |
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| Primary | Objective Functional Status by the Short Physical Performance Battery at 25 Weeks | Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better. | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Primary | Systolic Blood Pressure at 25 Weeks | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. | Posted | Mean | Standard Error | mm Hg | At the end of the 6-month intervention period (week 25) |
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| Primary | Diastolic Blood Pressure at 25 Weeks | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. | Posted | Mean | Standard Error | mm Hg | At the end of the 6-month intervention period (week 25) |
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| Primary | Performance of Lower Extremity Exercise at 52 Weeks | Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the subject reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period). | Posted | Mean | Standard Error | repetitions x sets/week | 6 months after the intervention period ends (week 52) |
|
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| Primary | Participation in Fitness Walking at 52 Weeks | Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period. | Posted | Mean | Standard Error | minutes | 6 months after the intervention period ends (week 52) |
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| Primary | Objective Functional Status by the 6-minute Walk at 52 Weeks | Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment. | Posted | Mean | Standard Error | yards | 6 months after the intervention period ends (week 52) |
|
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| Primary | Objective Functional Status by the Short Physical Performance Battery at 52 Weeks | Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better. | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| Primary | Systolic Blood Pressure at 52 Weeks | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. | Posted | Mean | Standard Error | mm Hg | 6 months after the intervention period ends (week 52) |
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| Primary | Diastolic Blood Pressure at 52 Weeks | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. | Posted | Mean | Standard Error | mm Hg | 6 months after the intervention period ends (week 52) |
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| Secondary | Subjective Functional Status at 25 Weeks | Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better. | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Secondary | Quadriceps Strength at 25 Weeks | Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials. | Posted | Mean | Standard Error | pounds | At the end of the 6-month intervention period (week 25) |
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| Secondary | Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks | Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better. | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Secondary | Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks | Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better. | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Secondary | Fatigue at 25 Weeks | Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better. | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Secondary | Health-Related Quality of Life at 25 Weeks | Measured by the Short Form-36v2 in terms of the following: Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Secondary | Self-Efficacy at 25 Weeks | Measured by the Self-Efficacy Scale in terms of the following: Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Secondary | Arthritis Self-Efficacy at 25 Weeks | Measured by the Arthritis Self-Efficacy Scale in terms of the following: Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Secondary | Outcome Expectancy at 25 Weeks | Measured by the Perceived Therapeutic Efficacy Scale in terms of the following: Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better | Posted | Mean | Standard Error | units on a scale | At the end of the 6-month intervention period (week 25) |
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| Secondary | Subjective Functional Status at 52 Weeks | Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better. | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| Secondary | Quadriceps Strength at 52 Weeks | Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials. | Posted | Mean | Standard Error | pounds | 6 months after the intervention period ends (week 52) |
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| Secondary | Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks | Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better. | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| Secondary | Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks | Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better. | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| Secondary | Fatigue at 52 Weeks | Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better. | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| Secondary | Health-Related Quality of Life at 52 Weeks | Measured by the Short Form-36v2 in terms of the following: Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| Secondary | Self-Efficacy at 52 Weeks | Measured by the Self-Efficacy Scale in terms of the following: Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| Secondary | Arthritis Self-Efficacy at 52 Weeks | Measured by the Arthritis Self-Efficacy Scale in terms of the following: Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| Secondary | Outcome Expectancy at 52 Weeks | Measured by the Perceived Therapeutic Efficacy Scale in terms of the following: Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention period ends (week 52) |
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| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | Attention-Control | Senior Health Information Intervention Attention-Control: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up. | 0 | 91 | 0 | 91 |
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Moderate-to-vigorous |
|
p=0.573 for Light |
| Superiority |
| Mixed Models Analysis | 0.197 | p=0.197 for Moderate-to-vigorous | Superiority |
| Moderate-to-vigorous |
|
p=0.823 for Light |
| Superiority |
| Mixed Models Analysis | 0.076 | p=0.076 for Moderate-to-vigorous | Superiority |
p=0.979 for Short Form-36v2 Physical Component |
| Superiority |
p=0.133 for Exercise Self-Efficacy |
| Superiority |
| Arthritis Self-Efficacy Other Symptoms |
|
p=0.948 for Arthritis Self Efficacy Function |
| Superiority |
| Mixed Models Analysis | 0.663 | p=0.663 for Arthritis Self Efficacy Other Symptoms | Superiority |
| 0.031 |
p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension |
| Superiority |
p=0.826 for Short Form-36v2 Physical Component |
| Superiority |
p=0.365 for Exercise Self-Efficacy |
| Superiority |
| Arthritis Self-Efficacy Other Symptoms |
|
p=0.340 for Arthritis Self Efficacy Function |
| Superiority |
| Mixed Models Analysis | 0.806 | p=0.806 for Arthritis Self Efficacy Other Symptoms | Superiority |
| 0.120 |
p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension |
| Superiority |