Staying Active With Arthritis: RCT of Physical Activity for Older Adults With Osteoarthritis and Hypertension

Hypertension Clinical Trial

— STAR  

Official title:

Promoting Physical Activity in Older Adults With Comorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280903
• Other study ID #: 1R01NR010904-01A1
• Secondary ID: R01NR010904-01A1
• Status: Completed
• Phase: N/A
• First received: December 17, 2010
• Last updated: January 2, 2018
• Start date: January 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 high blood pressure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh School of Nursing	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	At the end of the 6-month intervention period (week 25)
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.	At the end of the 6-month intervention period (week 25)
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.	At the end of the 6-month intervention period (week 25)
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.	At the end of the 6-month intervention period (week 25)
Primary	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)
Primary	Diastolic 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)
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).	6 months after the intervention period ends (week 52)
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.	6 months after the intervention period ends (week 52)
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.	6 months after the intervention period ends (week 52)
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.	6 months after the intervention period ends (week 52)
Primary	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)
Primary	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)
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.	At the end of the 6-month intervention period (week 25)
Secondary	Quadriceps Strength at 25 Weeks	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)
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.	At the end of the 6-month intervention period (week 25)
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.	At the end of the 6-month intervention period (week 25)
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.	At the end of the 6-month intervention period (week 25)
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	At the end of the 6-month intervention period (week 25)
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	At the end of the 6-month intervention period (week 25)
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	At the end of the 6-month intervention period (week 25)
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	At the end of the 6-month intervention period (week 25)
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.	6 months after the intervention period ends (week 52)
Secondary	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)
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.	6 months after the intervention period ends (week 52)
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.	6 months after the intervention period ends (week 52)
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.	6 months after the intervention period ends (week 52)
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	6 months after the intervention period ends (week 52)
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	6 months after the intervention period ends (week 52)
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	6 months after the intervention period ends (week 52)
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	6 months after the intervention period ends (week 52)