NCT00613678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

January 31, 2008

Last Update Submit

August 3, 2015

Conditions

Keywords

painactivities of daily livingsymptomsself-management

Outcome Measures

Primary Outcomes (1)

  • Self-reported pain

    Baseline, Post-intervention (8-wks), and 6-mos follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Behavioral: Education

2

EXPERIMENTAL

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.

Behavioral: Activity Strategy Training

Interventions

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.

2
EducationBEHAVIORAL

The health education program is based on educational materials from the Arthritis Foundation.

1

Eligibility Criteria

Age62 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Institute of Gerontology

Ann Arbor, Michigan, 48109-2007, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OsteoarthritisPain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Susan L Murphy, ScD, OTR

    University of Michigan, Institute of Gerontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

July 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations