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

Study Overview
=================
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.

Official Title
-----------------
Randomized Controlled Trial of Group-Based Exercise and Behavioral Health Skills Training for Older Adults With Painful Knee Osteoarthritis

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Behavioral: Behavioral Health
* Behavioral: Health Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age 65 years or older Community-dwelling Physician diagnosis of knee OA Knee pain that occurs almost daily for at least the past 3 months Knee pain-related difficulty with walking or climbing stairs Stiffness in the knee for <30 min/day in the morning Crepitus in the knee Exclusion criteria: Non-English speaking Cognitive impairment (Mini-Cog score ≤3) Unable or unwilling to give informed consent or accept randomization in either study group Unwilling to wear a thigh-mounted accelerometer for 1 week Significant, non-corrected visual or hearing impairment Plans to move out of the area in the next 12 months Plans to have knee, hip, or any other major surgery (including joint replacement) in the next 12 months Unable to walk a quarter of a mile independently (use of a straight cane is acceptable) Prior participation in cognitive-behavioral therapy or counseling for pain Exercises regularly (≥20 minutes/week of walking, hiking, dancing, or strength training, or participate in water exercise) Temporary exclusion: Any of the following in the past 6 months: cancer requiring treatment (except for non-melanoma skin cancer), heart attack or failure, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus Temporary exclusion: Hospitalization in the past month Temporary exclusion: Currently undergoing physical therapy or rehabilitation treatment for knee OA or impairments in mobility function

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Health<br>Ten behavioral health classes. | Behavioral: Behavioral Health<br>* Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity.<br>|
| Active Comparator: Health Education<br>Ten health education classes covering healthy aging. | Behavioral: Health Education<br>* Ten, group-based classes lasting one hour each that teaches topics related to aging and health (e.g., blood pressure control, maintaining healthy bones, cancer screening, immunizations).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Pain and Function | 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. | 4 months, 10 months | 
| 6 Minute Walk Test | 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. | 4 months, 10 months | 
| Timed Up and Go Test | 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. | 4 months, 10 months | 
| Short Physical Performance Battery | 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. | 4 months, 10 months | 
| Fatigue | 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. | 4 months, 10 months | 
| Study Specific Treatment Satisfaction Questionnaire | 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. | 4 months, 10 months | 
| Patient Global Impression of Change | 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. | 4 months, 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, chronic pain, behavioral health, exercise, physical activity, older adults