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

NCT ID: NCT01280903

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Osteoarthritis, Knee; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

STAR Intervention

Staying Active with Arthritis Intervention

Group Type: EXPERIMENTAL

STAR Intervention

Intervention Type: BEHAVIORAL

The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Attention-Control

Senior Health Information Intervention

Group Type: PLACEBO_COMPARATOR

Attention-Control

Intervention Type: BEHAVIORAL

Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Schlenk

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth A. Schlenk, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33039202 (View on PubMed)

Other Identifiers

R01NR010904-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO09110029

Identifier Type: -

Identifier Source: org_study_id