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

January 8, 2021 updated by: Kushang Patel, University of Washington

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kushang V Patel, PhD, MPH
  • Phone Number: 206-616-8052
  • Email: kvpatel@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195-6540
        • Recruiting
        • University of Washington
        • Contact:
          • Kushang Patel, PhD
          • Phone Number: 206-685-2082

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Health
Ten behavioral health classes.
Behavioral: Behavioral Health
Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity.
Active Comparator: Health Education
Ten health education classes covering healthy aging.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Number of Steps per day
Time Frame: 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.
4 months,10 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Kushang V Patel, PhD MPH, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007302
  • R01AG060992 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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