Hypertension, Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee, Hypertension, Exercise, Physical activity, Self Efficacy, Patient Compliance, Aged
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSTAR 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.
BEHAVIORALAttention-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.
Sponsors
National Institute of Nursing Research (NINR)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 50 years or older. * Is community dwelling. * Has osteoarthritis of the knee. * Has hypertension for which monotherapy or combination pharmacological treatment is prescribed. * Able to complete a behavioral run-in consisting of completing questionnaires, using a 7-day electronic-diary, and wearing an ActiGraph accelerometer at the waist for 7 days. * Has written permission to participate from the physician.
Exclusion criteria
* Reports currently doing lower extremity exercise =\> 2 times/week. * Reports currently fitness walking =\> 90 minutes/week. * Incapable of managing their own treatment regimen. * Does not have, or cannot use, a telephone or is unwilling to provide a telephone number. * Has received cortisone or Synvisc injections in the knee, angioplasty, stents, or a pacemaker in the past 6 months. * Reports unstable cardiovascular, pulmonary, or metabolic disease or signs and symptoms suggestive of cardiovascular, pulmonary, or metabolic disease that restrict activity. * Has resting systolic blood pressure =\> 160 mm Hg or diastolic blood pressure =\> 100 mm Hg. * Reports other conditions, such as osteoarthritis of the hip, spinal stenosis, inflammatory arthritis, foot drop, diabetes treated with insulin, or diabetic complications that may affect performance of lower extremity exercise and participation in fitness walking. * Reports current knee conditions, such as meniscus tears and knee ligament ruptures. * Reports major depression that may impact the ability to fully participate in this study. * Is scheduled to undergo a major surgical procedure in the next 13 months. * Is concurrently participating in a drug or psychoeducational trial that may confound, or be confounded by, participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure at 25 Weeks | At the end of the 6-month intervention period (week 25) | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. |
| Performance of Lower Extremity Exercise at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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). |
| Participation in Fitness Walking at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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. |
| Objective Functional Status by the 6-minute Walk at 25 Weeks | At the end of the 6-month intervention period (week 25) | Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment. |
| Objective Functional Status by the Short Physical Performance Battery at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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. |
| Diastolic Blood Pressure at 25 Weeks | At the end of the 6-month intervention period (week 25) | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. |
| Performance of Lower Extremity Exercise at 52 Weeks | 6 months after the intervention period ends (week 52) | 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). |
| Participation in Fitness Walking at 52 Weeks | 6 months after the intervention period ends (week 52) | 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. |
| Objective Functional Status by the 6-minute Walk at 52 Weeks | 6 months after the intervention period ends (week 52) | Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment. |
| Objective Functional Status by the Short Physical Performance Battery at 52 Weeks | 6 months after the intervention period ends (week 52) | 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. |
| Systolic Blood Pressure at 52 Weeks | 6 months after the intervention period ends (week 52) | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. |
| Diastolic Blood Pressure at 52 Weeks | 6 months after the intervention period ends (week 52) | Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks | 6 months after the intervention period ends (week 52) | Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better. |
| Fatigue at 52 Weeks | 6 months after the intervention period ends (week 52) | Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better. |
| Health-Related Quality of Life at 52 Weeks | 6 months after the intervention period ends (week 52) | 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 |
| Subjective Functional Status at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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. |
| Arthritis Self-Efficacy at 52 Weeks | 6 months after the intervention period ends (week 52) | 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 |
| Outcome Expectancy at 52 Weeks | 6 months after the intervention period ends (week 52) | 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 |
| Self-Efficacy at 52 Weeks | 6 months after the intervention period ends (week 52) | 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 |
| Quadriceps Strength at 25 Weeks | At the end of the 6-month intervention period (week 25) | Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials. |
| Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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. |
| Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks | At the end of the 6-month intervention period (week 25) | Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better. |
| Fatigue at 25 Weeks | At the end of the 6-month intervention period (week 25) | Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better. |
| Health-Related Quality of Life at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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 |
| Self-Efficacy at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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 |
| Arthritis Self-Efficacy at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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 |
| Outcome Expectancy at 25 Weeks | At the end of the 6-month intervention period (week 25) | 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 |
| Subjective Functional Status at 52 Weeks | 6 months after the intervention period ends (week 52) | 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. |
| Quadriceps Strength at 52 Weeks | 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. |
| Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks | 6 months after the intervention period ends (week 52) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 91 |
| 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. | 91 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 23 | 16 |
Baseline characteristics
| Characteristic | Total | STAR Intervention | Attention-Control |
|---|---|---|---|
| 6-minute walk | 485.5 yards STANDARD_DEVIATION 97.1 | 486.2 yards STANDARD_DEVIATION 105.9 | 484.7 yards STANDARD_DEVIATION 88.1 |
| 8-foot up-and-go | 6.6 seconds STANDARD_DEVIATION 1.6 | 6.5 seconds STANDARD_DEVIATION 1.8 | 6.6 seconds STANDARD_DEVIATION 1.3 |
| Activity minutes over 7 days (ActiGraph): light (counts of 100-2,019/min) | 2383.8 minutes STANDARD_DEVIATION 602.2 | 2348.7 minutes STANDARD_DEVIATION 572 | 2418.8 minutes STANDARD_DEVIATION 632.1 |
| Activity minutes over 7 days (ActiGraph): moderate-to-vigorous (counts of > 2,020/min) | 320.6 minutes STANDARD_DEVIATION 234.9 | 275.8 minutes STANDARD_DEVIATION 154 | 365.5 minutes STANDARD_DEVIATION 288.4 |
| Activity minutes over 7 days (ActiGraph): no to very low (counts of 0-99/min) | 3045.2 minutes STANDARD_DEVIATION 786.7 | 3155.5 minutes STANDARD_DEVIATION 714.6 | 2934.8 minutes STANDARD_DEVIATION 842.3 |
| Age, Continuous | 64.71 years STANDARD_DEVIATION 8.1 | 64.47 years STANDARD_DEVIATION 8.46 | 64.96 years STANDARD_DEVIATION 7.76 |
| Body mass index | 34.07 kg/m² STANDARD_DEVIATION 6.97 | 34.50 kg/m² STANDARD_DEVIATION 7.48 | 33.64 kg/m² STANDARD_DEVIATION 6.43 |
| Brief Fatigue Inventory | 2.8 units on a scale STANDARD_DEVIATION 2.4 | 2.8 units on a scale STANDARD_DEVIATION 2.6 | 2.7 units on a scale STANDARD_DEVIATION 2.2 |
| Chair sit-and-reach | -1.1 inches STANDARD_DEVIATION 5.6 | -1.4 inches STANDARD_DEVIATION 5.7 | -0.8 inches STANDARD_DEVIATION 5.6 |
| Diastolic blood pressure | 73.01 mm Hg STANDARD_DEVIATION 10.33 | 72.86 mm Hg STANDARD_DEVIATION 11.18 | 73.15 mm Hg STANDARD_DEVIATION 9.47 |
| Educational status > High school | 143 participants | 72 participants | 71 participants |
| Educational status High school or less | 39 participants | 19 participants | 19 participants |
| Educational status Missing | 0 participants | 0 participants | 1 participants |
| Employment status Employed | 88 participants | 45 participants | 43 participants |
| Employment status Not employed | 94 participants | 46 participants | 48 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 176 Participants | 88 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitness walking (e-dairy): days/week | 0.61 days/week STANDARD_DEVIATION 1.36 | 0.65 days/week STANDARD_DEVIATION 1.41 | 0.57 days/week STANDARD_DEVIATION 1.31 |
| Fitness walking (e-diary): average minutes/day | 2.42 average minutes/day STANDARD_DEVIATION 6.12 | 2.65 average minutes/day STANDARD_DEVIATION 6.78 | 2.19 average minutes/day STANDARD_DEVIATION 5.4 |
| Fitness walking (e-diary): minutes/week | 16.93 minutes/week STANDARD_DEVIATION 42.82 | 18.54 minutes/week STANDARD_DEVIATION 47.45 | 15.33 minutes/week STANDARD_DEVIATION 37.83 |
| Household income $50,000 or more/year | 77 participants | 39 participants | 38 participants |
| Household income < $50,000/year | 75 participants | 37 participants | 38 participants |
| Household income Missing | 30 participants | 15 participants | 15 participants |
| Lower extremity exercise (e-diary): average minutes/day | 1.07 average minutes/day STANDARD_DEVIATION 3.5 | 1.09 average minutes/day STANDARD_DEVIATION 3.55 | 1.06 average minutes/day STANDARD_DEVIATION 3.47 |
| Lower extremity exercise (e-diary): days/week | 0.38 days/week STANDARD_DEVIATION 1.01 | 0.41 days/week STANDARD_DEVIATION 1.01 | 0.36 days/week STANDARD_DEVIATION 1.02 |
| Lower extremity exercise (e-diary): minutes/week | 7.52 minutes/week STANDARD_DEVIATION 24.52 | 7.60 minutes/week STANDARD_DEVIATION 24.87 | 7.43 minutes/week STANDARD_DEVIATION 24.51 |
| Lower extremity exercise (e-diary): volume [repetitions x sets over 7-day period]/week | 43.67 repetitions x sets/week STANDARD_DEVIATION 199.79 | 56.93 repetitions x sets/week STANDARD_DEVIATION 255.39 | 30.41 repetitions x sets/week STANDARD_DEVIATION 121.21 |
| Marital status Married | 84 participants | 38 participants | 46 participants |
| Marital status Not married | 98 participants | 53 participants | 45 participants |
| Mean duration of bouts over 7 days (ActiGraph): bouts of moderate-to-vigorous activity n=96 | 18.6 minutes STANDARD_DEVIATION 8.2 | 17.2 minutes STANDARD_DEVIATION 7.5 | 19.9 minutes STANDARD_DEVIATION 8.7 |
| Mean number of daily activity minutes (ActiGraph): light (counts of 100-2,019/min) | 333.4 minutes STANDARD_DEVIATION 81.7 | 327.5 minutes STANDARD_DEVIATION 76.8 | 339.3 minutes STANDARD_DEVIATION 86.4 |
| Mean number of daily activity minutes (ActiGraph): moderate-to-vigorous (counts of >2,020/min) | 44.7 minutes STANDARD_DEVIATION 31.6 | 38.3 minutes STANDARD_DEVIATION 20.7 | 51.2 minutes STANDARD_DEVIATION 38.7 |
| Mean number of daily activity minutes (ActiGraph): no to very low (counts of 0-99/min) | 425.2 minutes STANDARD_DEVIATION 104.9 | 440.14 minutes STANDARD_DEVIATION 96.5 | 410.26 minutes STANDARD_DEVIATION 111.1 |
| Mean number of daily bouts (ActiGraph): bouts of moderate-to-vigorous activity | 0.3 bouts STANDARD_DEVIATION 0.7 | 0.2 bouts STANDARD_DEVIATION 0.4 | 0.4 bouts STANDARD_DEVIATION 0.9 |
| Number of bouts over 7 days (ActiGraph): bouts of moderate-to-vigorous activity | 2.2 bouts STANDARD_DEVIATION 5 | 1.7 bouts STANDARD_DEVIATION 2.6 | 2.7 bouts STANDARD_DEVIATION 6.5 |
| Number of comorbidities | 6.6 comorbidities STANDARD_DEVIATION 2.8 | 6.8 comorbidities STANDARD_DEVIATION 2.9 | 6.5 comorbidities STANDARD_DEVIATION 2.7 |
| Perceived Therapeutic Efficacy - Exercise & Arthritis | 70.0 units on a scale STANDARD_DEVIATION 23.1 | 67.8 units on a scale STANDARD_DEVIATION 24.5 | 72.1 units on a scale STANDARD_DEVIATION 21.7 |
| Perceived Therapeutic Efficacy - Exercise & Hypertension | 74.5 units on a scale STANDARD_DEVIATION 22.3 | 74.2 units on a scale STANDARD_DEVIATION 21.2 | 74.7 units on a scale STANDARD_DEVIATION 23.4 |
| Quadriceps strength (mean maximum for right and left quadriceps) | 42.4 pounds STANDARD_DEVIATION 14.8 | 41.8 pounds STANDARD_DEVIATION 13.5 | 43.0 pounds STANDARD_DEVIATION 16.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 17 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 132 Participants | 66 Participants | 66 Participants |
| Region of Enrollment United States | 182 participants | 91 participants | 91 participants |
| Self-efficacy: Arthritis Function | 84.2 units on a scale STANDARD_DEVIATION 15.6 | 83.1 units on a scale STANDARD_DEVIATION 15.5 | 85.2 units on a scale STANDARD_DEVIATION 15.6 |
| Self-efficacy: Arthritis Other Symptoms | 77.3 units on a scale STANDARD_DEVIATION 17.2 | 76.8 units on a scale STANDARD_DEVIATION 17.4 | 77.8 units on a scale STANDARD_DEVIATION 17.2 |
| Self-efficacy: Arthritis Pain | 74.1 units on a scale STANDARD_DEVIATION 17.6 | 73.7 units on a scale STANDARD_DEVIATION 17 | 74.4 units on a scale STANDARD_DEVIATION 18.2 |
| Self-efficacy: Exercise | 73.6 units on a scale STANDARD_DEVIATION 27.5 | 72.8 units on a scale STANDARD_DEVIATION 28 | 74.4 units on a scale STANDARD_DEVIATION 27.2 |
| Self-efficacy: Exercise Barriers | 64.3 units on a scale STANDARD_DEVIATION 23.9 | 60.3 units on a scale STANDARD_DEVIATION 25.6 | 68.3 units on a scale STANDARD_DEVIATION 21.4 |
| Sex: Female, Male Female | 133 Participants | 67 Participants | 66 Participants |
| Sex: Female, Male Male | 49 Participants | 24 Participants | 25 Participants |
| Short Form-36v2 Health Survey: Bodily Pain | 56.2 units on a scale STANDARD_DEVIATION 19.5 | 55.7 units on a scale STANDARD_DEVIATION 20.3 | 56.8 units on a scale STANDARD_DEVIATION 18.7 |
| Short Form-36v2 Health Survey: Mental Component Score | 53.7 units on a scale STANDARD_DEVIATION 9.6 | 53.4 units on a scale STANDARD_DEVIATION 9.8 | 54.0 units on a scale STANDARD_DEVIATION 9.4 |
| Short Form-36v2 Health Survey: Physical Component Score | 42.4 units on a scale STANDARD_DEVIATION 8.7 | 42.0 units on a scale STANDARD_DEVIATION 8.8 | 42.8 units on a scale STANDARD_DEVIATION 8.6 |
| Short Form-36v2 Health Survey: Physical Functioning | 63.6 units on a scale STANDARD_DEVIATION 21.6 | 62.0 units on a scale STANDARD_DEVIATION 23.4 | 65.2 units on a scale STANDARD_DEVIATION 19.7 |
| Short Physical Performance Battery: 4-meter usual walk | 4.0 units on a scale STANDARD_DEVIATION 0.2 | 4.0 units on a scale STANDARD_DEVIATION 0.2 | 4.0 units on a scale STANDARD_DEVIATION 0 |
| Short Physical Performance Battery: repeated chair stands | 2.8 units on a scale STANDARD_DEVIATION 1.1 | 2.9 units on a scale STANDARD_DEVIATION 1.2 | 2.7 units on a scale STANDARD_DEVIATION 1.1 |
| Short Physical Performance Battery: standing balance | 4.1 units on a scale STANDARD_DEVIATION 0.8 | 4.2 units on a scale STANDARD_DEVIATION 0.8 | 4.0 units on a scale STANDARD_DEVIATION 0.9 |
| Short Physical Performance Battery: total | 10.8 units on a scale STANDARD_DEVIATION 1.6 | 11.0 units on a scale STANDARD_DEVIATION 1.7 | 10.6 units on a scale STANDARD_DEVIATION 1.6 |
| Systolic blood pressure | 121.96 mm Hg STANDARD_DEVIATION 14.37 | 122.09 mm Hg STANDARD_DEVIATION 15.01 | 121.82 mm Hg STANDARD_DEVIATION 13.78 |
| Western Ontario and McMaster Universities Osteoarthritis Index: Function | 20.9 units on a scale STANDARD_DEVIATION 12.8 | 22.5 units on a scale STANDARD_DEVIATION 13.4 | 19.3 units on a scale STANDARD_DEVIATION 11.9 |
| Western Ontario and McMaster Universities Osteoarthritis Index: Pain | 5.3 units on a scale STANDARD_DEVIATION 3.5 | 5.8 units on a scale STANDARD_DEVIATION 3.9 | 4.8 units on a scale STANDARD_DEVIATION 3 |
| Western Ontario and McMaster Universities Osteoarthritis Index: Stiffness | 2.9 units on a scale STANDARD_DEVIATION 1.8 | 3.1 units on a scale STANDARD_DEVIATION 1.8 | 2.7 units on a scale STANDARD_DEVIATION 1.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 91 | 0 / 91 |
| serious Total, serious adverse events | 0 / 91 | 0 / 91 |
Outcome results
Primary
Diastolic Blood Pressure at 25 Weeks
Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Diastolic Blood Pressure at 25 Weeks | 71.74 mm Hg | Standard Error 1.2 |
| Attention-Control | Diastolic Blood Pressure at 25 Weeks | 73.10 mm Hg | Standard Error 1.16 |
p-value: 0.416Mixed Models Analysis
Primary
Diastolic Blood Pressure at 52 Weeks
Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Diastolic Blood Pressure at 52 Weeks | 72.62 mm Hg | Standard Error 1.22 |
| Attention-Control | Diastolic Blood Pressure at 52 Weeks | 74.06 mm Hg | Standard Error 1.18 |
p-value: 0.396Mixed Models Analysis
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.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Objective Functional Status by the 6-minute Walk at 25 Weeks | 465.46 yards | Standard Error 18.82 |
| Attention-Control | Objective Functional Status by the 6-minute Walk at 25 Weeks | 483.02 yards | Standard Error 14.47 |
p-value: 0.461Mixed Models Analysis
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.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Objective Functional Status by the 6-minute Walk at 52 Weeks | 480.29 yards | Standard Error 16.89 |
| Attention-Control | Objective Functional Status by the 6-minute Walk at 52 Weeks | 465.36 yards | Standard Error 19.26 |
p-value: 0.561Mixed Models Analysis
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.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Objective Functional Status by the Short Physical Performance Battery at 25 Weeks | 11.29 units on a scale | Standard Error 0.22 |
| Attention-Control | Objective Functional Status by the Short Physical Performance Battery at 25 Weeks | 10.86 units on a scale | Standard Error 0.23 |
p-value: 0.18Mixed Models Analysis
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.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Objective Functional Status by the Short Physical Performance Battery at 52 Weeks | 11.20 units on a scale | Standard Error 0.24 |
| Attention-Control | Objective Functional Status by the Short Physical Performance Battery at 52 Weeks | 11.25 units on a scale | Standard Error 0.19 |
p-value: 0.856Mixed Models Analysis
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.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Participation in Fitness Walking at 25 Weeks | None to very low | 434.89 minutes | Standard Error 11.69 |
| STAR Intervention | Participation in Fitness Walking at 25 Weeks | Light | 314.07 minutes | Standard Error 9.29 |
| STAR Intervention | Participation in Fitness Walking at 25 Weeks | Moderate-to-vigorous | 40.53 minutes | Standard Error 2.68 |
| Attention-Control | Participation in Fitness Walking at 25 Weeks | None to very low | 409.98 minutes | Standard Error 11.54 |
| Attention-Control | Participation in Fitness Walking at 25 Weeks | Light | 321.44 minutes | Standard Error 9.18 |
| Attention-Control | Participation in Fitness Walking at 25 Weeks | Moderate-to-vigorous | 46.69 minutes | Standard Error 3.93 |
p-value: 0.13Mixed Models Analysis
p-value: 0.573Mixed Models Analysis
p-value: 0.197Mixed Models Analysis
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.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Participation in Fitness Walking at 52 Weeks | None to very low | 426.71 minutes | Standard Error 11.97 |
| STAR Intervention | Participation in Fitness Walking at 52 Weeks | Light | 318.04 minutes | Standard Error 9.5 |
| STAR Intervention | Participation in Fitness Walking at 52 Weeks | Moderate-to-vigorous | 39.37 minutes | Standard Error 2.74 |
| Attention-Control | Participation in Fitness Walking at 52 Weeks | None to very low | 408.30 minutes | Standard Error 11.7 |
| Attention-Control | Participation in Fitness Walking at 52 Weeks | Light | 321.01 minutes | Standard Error 9.3 |
| Attention-Control | Participation in Fitness Walking at 52 Weeks | Moderate-to-vigorous | 47.97 minutes | Standard Error 3.97 |
p-value: 0.272Mixed Models Analysis
p-value: 0.823Mixed Models Analysis
p-value: 0.076Mixed Models Analysis
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).
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Performance of Lower Extremity Exercise at 25 Weeks | 46.84 repetitions x sets/week | Standard Error 4.59 |
| Attention-Control | Performance of Lower Extremity Exercise at 25 Weeks | 1.90 repetitions x sets/week | Standard Error 0.86 |
p-value: <0.0001Mixed Models Analysis
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).
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Performance of Lower Extremity Exercise at 52 Weeks | 42.06 repetitions x sets/week | Standard Error 6.74 |
| Attention-Control | Performance of Lower Extremity Exercise at 52 Weeks | 3.14 repetitions x sets/week | Standard Error 1.22 |
p-value: <0.0001Mixed Models Analysis
Primary
Systolic Blood Pressure at 25 Weeks
Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Systolic Blood Pressure at 25 Weeks | 120.33 mm Hg | Standard Error 1.74 |
| Attention-Control | Systolic Blood Pressure at 25 Weeks | 123.07 mm Hg | Standard Error 1.68 |
p-value: 0.258Mixed Models Analysis
Primary
Systolic Blood Pressure at 52 Weeks
Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Systolic Blood Pressure at 52 Weeks | 122.54 mm Hg | Standard Error 1.78 |
| Attention-Control | Systolic Blood Pressure at 52 Weeks | 125.14 mm Hg | Standard Error 1.71 |
p-value: 0.292Mixed Models Analysis
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
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Arthritis Self-Efficacy at 25 Weeks | Arthritis Self Efficacy Pain | 75.58 units on a scale | Standard Error 1.97 |
| STAR Intervention | Arthritis Self-Efficacy at 25 Weeks | Arthritis Self-Efficacy Function | 85.74 units on a scale | Standard Error 1.79 |
| STAR Intervention | Arthritis Self-Efficacy at 25 Weeks | Arthritis Self-Efficacy Other Symptoms | 78.88 units on a scale | Standard Error 1.99 |
| Attention-Control | Arthritis Self-Efficacy at 25 Weeks | Arthritis Self Efficacy Pain | 67.38 units on a scale | Standard Error 2.13 |
| Attention-Control | Arthritis Self-Efficacy at 25 Weeks | Arthritis Self-Efficacy Function | 85.90 units on a scale | Standard Error 1.67 |
| Attention-Control | Arthritis Self-Efficacy at 25 Weeks | Arthritis Self-Efficacy Other Symptoms | 77.66 units on a scale | Standard Error 1.95 |
p-value: 0.005Mixed Models Analysis
p-value: 0.948Mixed Models Analysis
p-value: 0.663Mixed Models Analysis
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
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Arthritis Self-Efficacy at 52 Weeks | Arthritis Self-Efficacy Pain | 73.15 units on a scale | Standard Error 2.06 |
| STAR Intervention | Arthritis Self-Efficacy at 52 Weeks | Arthritis Self-Efficacy Function | 85.38 units on a scale | Standard Error 1.82 |
| STAR Intervention | Arthritis Self-Efficacy at 52 Weeks | Arthritis Self-Efficacy Other Symptoms | 75.92 units on a scale | Standard Error 2.03 |
| Attention-Control | Arthritis Self-Efficacy at 52 Weeks | Arthritis Self-Efficacy Pain | 69.44 units on a scale | Standard Error 2.19 |
| Attention-Control | Arthritis Self-Efficacy at 52 Weeks | Arthritis Self-Efficacy Function | 87.75 units on a scale | Standard Error 1.69 |
| Attention-Control | Arthritis Self-Efficacy at 52 Weeks | Arthritis Self-Efficacy Other Symptoms | 75.23 units on a scale | Standard Error 1.96 |
p-value: 0.219Mixed Models Analysis
p-value: 0.34Mixed Models Analysis
p-value: 0.806Mixed Models Analysis
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.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Fatigue at 25 Weeks | 2.49 units on a scale | Standard Error 0.27 |
| Attention-Control | Fatigue at 25 Weeks | 2.76 units on a scale | Standard Error 0.25 |
p-value: 0.466Mixed Models Analysis
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.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Fatigue at 52 Weeks | 2.97 units on a scale | Standard Error 0.28 |
| Attention-Control | Fatigue at 52 Weeks | 2.94 units on a scale | Standard Error 0.25 |
p-value: 0.947Mixed Models Analysis
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
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Health-Related Quality of Life at 25 Weeks | Short Form-36v2 Mental Component | 53.92 units on a scale | Standard Error 1.11 |
| STAR Intervention | Health-Related Quality of Life at 25 Weeks | Short Form-36v2 Physical Component | 43.10 units on a scale | Standard Error 0.97 |
| Attention-Control | Health-Related Quality of Life at 25 Weeks | Short Form-36v2 Mental Component | 52.30 units on a scale | Standard Error 1.2 |
| Attention-Control | Health-Related Quality of Life at 25 Weeks | Short Form-36v2 Physical Component | 43.07 units on a scale | Standard Error 0.95 |
p-value: 0.322Mixed Models Analysis
p-value: 0.979Mixed Models Analysis
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
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Health-Related Quality of Life at 52 Weeks | Short Form-36v2 Mental Component | 53.18 units on a scale | Standard Error 1.12 |
| STAR Intervention | Health-Related Quality of Life at 52 Weeks | Short Form-36v2 Physical Component | 42.10 units on a scale | Standard Error 1.18 |
| Attention-Control | Health-Related Quality of Life at 52 Weeks | Short Form-36v2 Mental Component | 51.81 units on a scale | Standard Error 1.21 |
| Attention-Control | Health-Related Quality of Life at 52 Weeks | Short Form-36v2 Physical Component | 42.47 units on a scale | Standard Error 1.15 |
p-value: 0.406Mixed Models Analysis
p-value: 0.826Mixed Models Analysis
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
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Outcome Expectancy at 25 Weeks | Perceived Therapeutic Efficacy Arthritis | 72.79 units on a scale | Standard Error 2.41 |
| STAR Intervention | Outcome Expectancy at 25 Weeks | Perceived Therapeutic Efficacy Hypertension | 77.14 units on a scale | Standard Error 2.48 |
| Attention-Control | Outcome Expectancy at 25 Weeks | Perceived Therapeutic Efficacy Arthritis | 59.67 units on a scale | Standard Error 2.91 |
| Attention-Control | Outcome Expectancy at 25 Weeks | Perceived Therapeutic Efficacy Hypertension | 69.62 units on a scale | Standard Error 2.42 |
p-value: 0.001Mixed Models Analysis
p-value: 0.031Mixed Models Analysis
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
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Outcome Expectancy at 52 Weeks | Perceived Therapeutic Efficacy Hypertension | 73.40 units on a scale | Standard Error 2.53 |
| STAR Intervention | Outcome Expectancy at 52 Weeks | Perceived Therapeutic Efficacy Arthritis | 67.09 units on a scale | Standard Error 2.83 |
| Attention-Control | Outcome Expectancy at 52 Weeks | Perceived Therapeutic Efficacy Arthritis | 55.86 units on a scale | Standard Error 3.07 |
| Attention-Control | Outcome Expectancy at 52 Weeks | Perceived Therapeutic Efficacy Hypertension | 67.93 units on a scale | Standard Error 2.44 |
p-value: 0.008Mixed Models Analysis
p-value: 0.12t-test, 1 sided
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.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks | 59.65 units on a scale | Standard Error 2.32 |
| Attention-Control | Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks | 58.13 units on a scale | Standard Error 2.26 |
p-value: 0.639Mixed Models Analysis
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.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks | 59.73 units on a scale | Standard Error 2.36 |
| Attention-Control | Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks | 59.70 units on a scale | Standard Error 2.28 |
p-value: 0.993Mixed Models Analysis
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.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks | 4.25 units on a scale | Standard Error 0.39 |
| Attention-Control | Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks | 4.54 units on a scale | Standard Error 0.38 |
p-value: 0.596Mixed Models Analysis
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.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks | 4.09 units on a scale | Standard Error 0.41 |
| Attention-Control | Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks | 4.72 units on a scale | Standard Error 0.39 |
p-value: 0.26Mixed Models Analysis
Secondary
Quadriceps Strength at 25 Weeks
Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Quadriceps Strength at 25 Weeks | 43.21 pounds | Standard Error 1.75 |
| Attention-Control | Quadriceps Strength at 25 Weeks | 41.88 pounds | Standard Error 1.71 |
p-value: 0.586Mixed Models Analysis
Secondary
Quadriceps Strength at 52 Weeks
Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Quadriceps Strength at 52 Weeks | 43.66 pounds | Standard Error 1.77 |
| Attention-Control | Quadriceps Strength at 52 Weeks | 43.33 pounds | Standard Error 1.73 |
p-value: 0.895Mixed Models Analysis
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
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Self-Efficacy at 25 Weeks | Exercise Barriers Self-Efficacy | 59.81 units on a scale | Standard Error 2.77 |
| STAR Intervention | Self-Efficacy at 25 Weeks | Exercise Self-Efficacy | 67.43 units on a scale | Standard Error 3.44 |
| Attention-Control | Self-Efficacy at 25 Weeks | Exercise Barriers Self-Efficacy | 58.37 units on a scale | Standard Error 2.69 |
| Attention-Control | Self-Efficacy at 25 Weeks | Exercise Self-Efficacy | 60.20 units on a scale | Standard Error 3.35 |
p-value: 0.71Mixed Models Analysis
p-value: 0.133Mixed Models Analysis
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
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STAR Intervention | Self-Efficacy at 52 Weeks | Exercise Barriers Self-Efficacy | 53.30 units on a scale | Standard Error 2.83 |
| STAR Intervention | Self-Efficacy at 52 Weeks | Exercise Self-Efficacy | 55.49 units on a scale | Standard Error 3.56 |
| Attention-Control | Self-Efficacy at 52 Weeks | Exercise Barriers Self-Efficacy | 53.05 units on a scale | Standard Error 2.73 |
| Attention-Control | Self-Efficacy at 52 Weeks | Exercise Self-Efficacy | 51.00 units on a scale | Standard Error 3.43 |
p-value: 0.95Mixed Models Analysis
p-value: 0.365Mixed Models Analysis
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.
Time frame: At the end of the 6-month intervention period (week 25)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Subjective Functional Status at 25 Weeks | 16.68 units on a scale | Standard Error 1.44 |
| Attention-Control | Subjective Functional Status at 25 Weeks | 18.30 units on a scale | Standard Error 1.42 |
p-value: 0.424Mixed Models Analysis
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.
Time frame: 6 months after the intervention period ends (week 52)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STAR Intervention | Subjective Functional Status at 52 Weeks | 17.02 units on a scale | Standard Error 1.49 |
| Attention-Control | Subjective Functional Status at 52 Weeks | 17.51 units on a scale | Standard Error 1.44 |
p-value: 0.816Mixed Models Analysis