Clinical trial NCT01280903: Staying Active With Arthritis: RCT of Physical Activity for Older Adults With Osteoarthritis and Hypertension
Official title: Promoting Physical Activity in Older Adults With Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Hypertension
Keywords: Osteoarthritis, Knee
Hypertension
Exercise
Physical activity
Self Efficacy
Patient Compliance
Aged
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-01-21
Enrollment: 182
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance of Lower Extremity Exercise at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Participation in Fitness Walking at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Objective Functional Status by the 6-minute Walk at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Objective Functional Status by the Short Physical Performance Battery at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Systolic Blood Pressure at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Diastolic Blood Pressure at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Performance of Lower Extremity Exercise at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Participation in Fitness Walking at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Objective Functional Status by the 6-minute Walk at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Objective Functional Status by the Short Physical Performance Battery at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Systolic Blood Pressure at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Diastolic Blood Pressure at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
Secondary outcomes:
measure: Subjective Functional Status at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Quadriceps Strength at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Fatigue at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Health-Related Quality of Life at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Self-Efficacy at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Arthritis Self-Efficacy at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Outcome Expectancy at 25 Weeks
timeFrame: At the end of the 6-month intervention period (week 25)
measure: Subjective Functional Status at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Quadriceps Strength at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Fatigue at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Health-Related Quality of Life at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Self-Efficacy at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Arthritis Self-Efficacy at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
measure: Outcome Expectancy at 52 Weeks
timeFrame: 6 months after the intervention period ends (week 52)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Nursing
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth A. Schlenk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.