Osteoarthritis, KneeSTARNCT01280903
Staying Active With Arthritis: RCT of Physical Activity for Older Adults With Osteoarthritis and Hypertension
A study testing STAR Intervention in people with Osteoarthritis, Knee and Hypertension, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Hypertension
- What is being tested?
- STAR Intervention
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Promoting Physical Activity in Older Adults With Comorbidity
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Hypertension
- Being tested
- STAR Intervention, Attention-Control
- Keywords
- Osteoarthritis, Knee, Hypertension, Exercise, Physical activity, Self Efficacy, Patient Compliance, Aged
- Medical subject headings
- Osteoarthritis, Knee, Hypertension, Motor Activity, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR InterventionBehavioural
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.
Attention-ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STAR Intervention | Experimental | Staying Active with Arthritis Intervention Receives: Behavioral: STAR Intervention |
| Attention-Control | Placebo comparator | Senior Health Information Intervention Receives: Behavioral: Attention-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the 6-month intervention period (week 25)
Diastolic Blood Pressure at 25 Weeks
Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after the intervention period ends (week 52)
Secondary outcomes (18)
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.
Measured: At the end of the 6-month intervention period (week 25)
Quadriceps Strength at 25 Weeks
Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after the intervention period ends (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Elizabeth Schlenk, University of Pittsburgh
- Investigators
- Elizabeth A. Schlenk, PhD, RN, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280903
- Sponsor's protocol ID
- PRO09110029
- Other IDs
- R01NR010904-01A1
- Acronym
- STAR
- Status last verified
- Sep 2024
- First submitted
- 17 Dec 2010
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33039202
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity in Older Adults With Comorbidity
- ClinicalTrials.gov ID
- NCT01280903
- Acronym / sponsor ID
- STAR / PRO09110029
- Conditions
- Osteoarthritis, Knee, Hypertension
- Keywords
- Osteoarthritis, Knee, Hypertension, Exercise, Physical activity, Self Efficacy, Patient Compliance, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 31 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAR Intervention | Experimental | Behavioral: STAR InterventionStaying Active with Arthritis Intervention |
| Attention-Control | Placebo comparator | Behavioral: Attention-ControlSenior Health Information Intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR InterventionThe 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. | Behavioural | STAR Intervention |
| Attention-ControlAttention-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. | Behavioural | Attention-Control |
Primary outcome
Performance of Lower Extremity Exercise at 25 Weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Systolic Blood Pressure at 25 Weeks
Time frame: 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.
Diastolic Blood Pressure at 25 Weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months after the intervention period ends (week 52)
Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.
18 secondary outcomes
Subjective Functional Status at 25 Weeks
Time frame: At the end of the 6-month intervention period (week 25)
Quadriceps Strength at 25 Weeks
Time frame: 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
Time frame: 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
Time frame: At the end of the 6-month intervention period (week 25)
Fatigue at 25 Weeks
Time frame: At the end of the 6-month intervention period (week 25)
Health-Related Quality of Life at 25 Weeks
Time frame: At the end of the 6-month intervention period (week 25)
Self-Efficacy at 25 Weeks
Time frame: At the end of the 6-month intervention period (week 25)
Arthritis Self-Efficacy at 25 Weeks
Time frame: At the end of the 6-month intervention period (week 25)
Outcome Expectancy at 25 Weeks
Time frame: At the end of the 6-month intervention period (week 25)
Subjective Functional Status at 52 Weeks
Time frame: 6 months after the intervention period ends (week 52)
Quadriceps Strength at 52 Weeks
Time frame: 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
Time frame: 6 months after the intervention period ends (week 52)
Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks
Time frame: 6 months after the intervention period ends (week 52)
Fatigue at 52 Weeks
Time frame: 6 months after the intervention period ends (week 52)
Health-Related Quality of Life at 52 Weeks
Time frame: 6 months after the intervention period ends (week 52)
Self-Efficacy at 52 Weeks
Time frame: 6 months after the intervention period ends (week 52)
Arthritis Self-Efficacy at 52 Weeks
Time frame: 6 months after the intervention period ends (week 52)
Outcome Expectancy at 52 Weeks
Time frame: 6 months after the intervention period ends (week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33039202Schlenk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A. Schlenk, PhD, RN principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR Intervention in people with Osteoarthritis, Knee and Hypertension, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Lower Extremity Exercise at 25 Weeks (time frame: At the end of the 6-month intervention period (week 25)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01280903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.