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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2025-01-31

Brief Summary

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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).

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Detailed Description

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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. Due to the COVID-19 pandemic, all interventions transitioned to remote delivery in 2020.

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavioral Health

Ten behavioral health classes.

Group Type EXPERIMENTAL

Behavioral Health

Intervention Type BEHAVIORAL

Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity.

Health Education

Ten health education classes covering healthy aging.

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

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).

Interventions

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Behavioral Health

Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity.

Intervention Type BEHAVIORAL

Health Education

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No