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Exercise Plus Activity Strategy Training for Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activity Strategy Training
Education
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring pain, activities of daily living, symptoms, self-management

Eligibility Criteria

62 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Minimum age of 62 years
  • Meet ACR clinical criteria for either hip or knee OA
  • Ambulatory (with or without assistance)
  • Requiring assistance or report difficulty in >=1/4 activities of daily living
  • Ability to speak English

Exclusion Criteria:

  • Knee/hip surgery within the previous 9 mos.
  • Current participation in physical/occupational therapy
  • Any contraindication to exercise activities
  • Cognitive impairment
  • Inability to provide informed consent

Sites / Locations

  • University of Michigan Institute of Gerontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Exercise + Education: Eight group sessions (8-15 people) during which participants engage in muscular strength and flexibility exercises. In addition, weekly educational lectures on topics germane to osteoarthritis management are included.

Exercise + Activity Strategy Training: 7/8 sessions will be in a group format in which participants engage in muscular strength & flexibility exercises and listen to education lessons on management strategies for osteoarthritis. The remaining session includes a home assessment by an occupational therapist to facilitate adequate participation in daily living and leisure activities.

Outcomes

Primary Outcome Measures

Self-reported pain

Secondary Outcome Measures

Full Information

First Posted
January 31, 2008
Last Updated
August 3, 2015
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00613678
Brief Title
Exercise Plus Activity Strategy Training for Osteoarthritis
Official Title
Exercise Plus Activity Strategy Training for Older Adults With Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose: To study the effects of two different rehabilitation programs for people with osteoarthritis of the hip or knee. Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and physical disability at 8-weeks and 6-months follow-up. Hypothesis 2: Participants who receive Activity Strategy Training will have a greater increase in physical activity as measured by a wrist-worn accelerometer. Hypothesis 3: Participants who receive Activity Stratgey Training will report greater improvements in health-related quality of life.
Detailed Description
We are testing the effectiveness of a targeted intervention for older adults with hip and/or knee osteoarthritis (LE-OA) using an occupational therapy treatment approach to promote activity engagement. We believe that it is necessary to tailor this intervention to the specific needs of older adults with LE-OA. Based on the literature, exercise is a necessary component of an intervention for older adults with LE-OA. However, this should also be coupled with an Activity Strategy Training (AST) component designed to promote lifestyle changes and thus more lasting effects. The AST component is based on occupational therapy principles and will include behavioral and environmental strategies to increase activity engagement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
pain, activities of daily living, symptoms, self-management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Exercise + Education: Eight group sessions (8-15 people) during which participants engage in muscular strength and flexibility exercises. In addition, weekly educational lectures on topics germane to osteoarthritis management are included.
Arm Title
2
Arm Type
Experimental
Arm Description
Exercise + Activity Strategy Training: 7/8 sessions will be in a group format in which participants engage in muscular strength & flexibility exercises and listen to education lessons on management strategies for osteoarthritis. The remaining session includes a home assessment by an occupational therapist to facilitate adequate participation in daily living and leisure activities.
Intervention Type
Behavioral
Intervention Name(s)
Activity Strategy Training
Intervention Description
The AST component will involve training in specific behavioral and environmental strategies to facilitate performance in daily activities and routines. The activity strategy training group sessions will use education, group discussion, and demonstration and practice of techniques to facilitate activity performance. Homework assignments will be given after many of the sessions to practice and reinforce concepts learned.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
The health education program is based on educational materials from the Arthritis Foundation.
Primary Outcome Measure Information:
Title
Self-reported pain
Time Frame
Baseline, Post-intervention (8-wks), and 6-mos follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum age of 62 years Meet ACR clinical criteria for either hip or knee OA Ambulatory (with or without assistance) Requiring assistance or report difficulty in >=1/4 activities of daily living Ability to speak English Exclusion Criteria: Knee/hip surgery within the previous 9 mos. Current participation in physical/occupational therapy Any contraindication to exercise activities Cognitive impairment Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Murphy, ScD, OTR
Organizational Affiliation
University of Michigan, Institute of Gerontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Institute of Gerontology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18821646
Citation
Murphy SL, Strasburg DM, Lyden AK, Smith DM, Koliba JF, Dadabhoy DP, Wallis SM. Effects of activity strategy training on pain and physical activity in older adults with knee or hip osteoarthritis: a pilot study. Arthritis Rheum. 2008 Oct 15;59(10):1480-7. doi: 10.1002/art.24105.
Results Reference
derived

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Exercise Plus Activity Strategy Training for Osteoarthritis

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