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Group Physical Therapy for Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Physical Therapy
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis focused on measuring Osteoarthritis, Veterans, Physical Therapy, Health Services Research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Radiographic Evidence of Knee Osteoarthritis and a Clinician's Diagnosis
  • Current knee symptoms

Exclusion Criteria:

  • Presence of other rheumatological conditions (such as rheumatoid arthritis and fibromyalgia) - Other health-related problem that would prevent safe participation in a physical therapy program - Currently undergoing physical therapy for knee OA, participation in another interventional study, scheduled or on waiting list for joint replacement surgery, resident of nursing home

Sites / Locations

  • Durham VA Medical Center, Durham, NC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Physical Therapy

Arm Description

12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2008
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00642772
Brief Title
Group Physical Therapy for Knee Osteoarthritis
Official Title
Pilot Study of Group Physical Therapy for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Osteoarthritis (OA) is a common cause of pain and disability. Physical therapy is a key part of treatment for OA, but VA Medical Centers are often limited in their capacity to provide physical therapy services for veterans with knee OA. The goal of this study is to perform a preliminary work on a group-based physical therapy program for veterans with knee osteoarthritis (OA), in preparation for a larger project. This work will allow us to assess the feasibility of conducting group-based physical therapy program and to plan a larger grant submission based on the findings of this initial study. We hypothesize that the group-based program will be feasible to administer and will result in improved pain and function.
Detailed Description
Background / Rationale: Osteoarthritis (OA) is the one of the most common chronic conditions among veterans, and over half of VA health care users with OA report being limited in their daily activities because of joint symptoms. Physical therapy and ongoing exercise help to reduce pain and improve physical function. However, the majority of veterans with OA are physically inactive. Furthermore, physical therapy appointments in the VA health care system are a limited resource, with demand often exceeding supply, resulting in long wait periods and a limited number of visits (1 or 2) per patient. Extending physical therapy services to a larger number of veterans with OA, in a cost effective manner, may play a key role in improving outcomes in this large patient group. Objective: The objective of this pilot study is to perform preliminary evaluation of group-based physical therapy program for veterans with knee OA, in preparation for a larger grant submission. This pilot work will allow us to assess the feasibility of group-based sessions, refine the intervention session components as needed, assess the planned recruitment and enrollment methods, estimate the number of potentially eligible veterans at the Durham VAMC, and conduct sample size and power analyses for a larger clinical trial. Methods: All participants will be involved in a 12-week group-based physical therapy program, with study measures being obtained at baseline and immediately following program completion. Participants will be Durham VAMC patients with symptomatic knee OA. Our goal is to enroll 20 participants who complete the program and follow-up measures, but we may recruit up to 25 participants total, if some participants drop out of the program before completion. Participants will attend group physical therapy sessions bi-weekly for twelve weeks (total of six visits), with each session lasting approximately one hour. Two study team members, a licensed physical therapist and research assistant with training in exercise for knee OA, will lead each session. The research assistant will lead group exercises, and the physical therapist will assess the progress and monitor for any potential problems or special needs of individual patients. During the first 10-15 minutes of each group session, one study team member will talk with participants about a topic related to OA care, such as joint protection, weight management, joint injections and surgery, and stress management. The remainder of the session will involve group warm-up / stretching exercises, then a series of strengthening exercises tailored for patients with knee OA. Participants will also be instructed to perform stretching exercises daily and strengthening exercises three times total each week. Primary outcome measures will be self-reported pain and function. Statistical analyses will compare pre- and post-intervention pain and function, including effect size calculations to assist with sample size estimates for a larger study. Impact: This study is significant because it examines a novel health services delivery method for improving outcomes among patients with OA - a highly prevalent condition that is also one of the main causes of pain among veterans. Specifically, this pilot study is a key first step toward examining the efficacy and cost-effectiveness of a method for delivering physical therapy services to a larger number of veterans with OA. This delivery method could also be applied to other common orthopedic and neurologic conditions that require physical therapy service.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Veterans, Physical Therapy, Health Services Research

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Physical Therapy
Arm Type
Experimental
Arm Description
12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
Intervention Type
Other
Intervention Name(s)
Group Physical Therapy
Intervention Description
12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.
Time Frame
Baseline and Following 12-Week Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Radiographic Evidence of Knee Osteoarthritis and a Clinician's Diagnosis Current knee symptoms Exclusion Criteria: Presence of other rheumatological conditions (such as rheumatoid arthritis and fibromyalgia) - Other health-related problem that would prevent safe participation in a physical therapy program - Currently undergoing physical therapy for knee OA, participation in another interventional study, scheduled or on waiting list for joint replacement surgery, resident of nursing home
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli Dominick Allen, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Group Physical Therapy for Knee Osteoarthritis

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