Pain & Aging: Combined Interventions for Fitness in the Community Study

Not Applicable

• Conditions: Osteo Arthritis Knee
• Interventions: Behavioral: Behavioral Health; Behavioral: Health Education

• Registration Number: NCT04099394
• Lead Sponsor: University of Washington

Brief Summary

This clinical trial will determine the added benefit of combining exercise and behavioral health education (versus exercise and aging and health education) to improve physical activity in community-dwelling older adults who have painful knee osteoarthritis (OA).

Detailed Description

Knee osteoarthritis (OA) is a highly prevalent, leading cause of pain that limits physical functioning in older adults. Although clinical practice guidelines recommend physical exercise for managing symptoms of knee OA, several systematic reviews indicate that exercise intervention studies provide only short-term benefits (lasting 6 months) for knee OA. Many older adults with painful knee OA return to sedentary lifestyles when structured exercise programs end6. Efforts to increase and sustain physical activity in this population will require promoting self-regulatory skills to develop confidence to maintain an active lifestyle and manage symptoms that often limit activity. Therefore, we developed a group-based behavioral health (BH) program for older adults with painful knee OA that complements Enhance Fitness (EF) - a multicomponent, community-based exercise program for older adults, involving balance, strength, and endurance training. The Behavioral Health (BH) program will have 10, 1-hour weekly classes spread over 4 months, while the Health Education (HE) program will be equally matched for attention with classes on aging and health. In parallel with BH/HE programs, all study subjects will participate in Enhance Fitness (EF) exercise classes that will be held for 1-hour, 3 times a week for 4 months. EF+BH intervention (versus EF+HE) improves physical activity, pain, physical function, and other outcomes in older adults with knee OA.

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Study Start: 2019-10-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-11
• Primary Completion: 2024-01-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Health	Behavioral Health	Ten behavioral health classes.
Health Education	Health Education	Ten health education classes covering healthy aging.

Primary Outcome Measures

Name	Time	Method
Average Number of Steps per day	4 months,10 months	Participant's average number of steps per day will be measured by a thigh mounted accelerometer (acitvPAL) worn for 1 week.

Secondary Outcome Measures

Name	Time	Method
Fatigue	4 months, 10 months	The PROMIS-57 Profile v2.1 will be collected, which includes 8 question items on fatigue. The PROMIS fatigue score ranges 0-100 with higher scores indicating worse outcome.
Study Specific Treatment Satisfaction Questionnaire	4 months, 10 months	This multi-item measure assesses overall participant satisfaction with the study as well as individual treatment components. These questions were developed specifically for the PACIFIC Study. Overall and treatment-specific satisfaction scores range 20-100 with higher scores indicating better outcome.
Knee Pain and Function	4 months, 10 months	The Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used. This is a reliable, validated, and widely used patient-reported outcome measure for assessing knee pain and knee pain-related functional limitations in clinical trials of exercise in adults with knee OA. The knee pain and knee pain-related functional limitation subscales range 0-100 with higher scores indicating better outcome.
Timed Up and Go Test	4 months, 10 months	Mobility will be measured by the Timed up Go. This is a recommended performance-based measures to assess interventions in adults with knee OA and in older adults in general, facilitating comparisons with previous exercise trials.
Patient Global Impression of Change	4 months, 10 months	This is a widely used single item assessment of overall change in health status following treatment on a 7-point scale. Participants are asked, "Since the start of the study my overall status is: (1) Very much improved; (2) Much improved; (3) Minimally improved; (4) No change; (5) Minimally worse; (6) Much worse; and (7) Very much worse".
6 Minute Walk Test	4 months, 10 months	Mobility will be measured by the 6-Minute Walk Test. This is a recommended performance-based measures to assess interventions in adults with knee OA and in older adults in general, facilitating comparisons with previous exercise trials.
Short Physical Performance Battery	4 months, 10 months	Mobility will be measured by the Short Physical Performance Battery. This is a recommended performance-based measures to assess interventions in adults with knee OA and in older adults in general, facilitating comparisons with previous exercise trials.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States