Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability
March 11, 2020 updated by: Nels Carlson, Oregon Health and Science University
Hip Osteoarthritis: Effects of Structured Exercise Programs on Pain and Long-term Disability
Osteoarthritis is the most common form of arthritis in the United States.
It is estimated that 20 million Americans have arthritis, and the annual societal cost is $95 billion.
Several exercise studies have shown modest improvements in disability, physical performance, and pain in subjects with knee osteoarthritis.
While similar results have been suggested in hip osteoarthritis, well-designed randomized clinical trials have not been conducted.
Exercise programs appear beneficial but without adherence, the beneficial effects of exercise for knee and hip osteoarthritis decline over time.
A well-designed, evidence-based, arthritis-specific study controlling for exercise duration, frequency and adherence is needed.
The objective of this study is to determine the effects of structured exercise programs on self-reported pain and disability in adults with hip osteoarthritis.
This prospective, randomized study with a wait-list control is designed to develop preliminary data to support an R01 funding request for a large, randomized clinical trial.
All exercise interventions and outcome assessments will take place at OHSU in the Orthopaedics and Rehabilitation Clinics, Rehabilitation Services physical therapy gym, and the General Clinical Research Center.
Subjects will be selected to include individuals representative of the larger population with documented hip osteoarthritis.
This three-month study will evaluate the effects of an aerobic and resistance exercise program on pain and disability in individuals with hip osteoarthritis.
Outcome assessment will follow the Outcome Measures in Rheumatology (OMERACT) recommendations for a core set of outcome measures for clinical trials in arthritis and assess pain, physical function, patient global assessment, and joint imaging.
Data analysis will focus on comparing pre- and post-intervention endpoints using conventional statistical analyses such as repeated-measure analysis of variance for repeated continuous measures (e.g.
walking distance), and non-parametric methods such as Chi-square or frequency analysis for proportions (e.g.
visual pain scores).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
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 Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University Center for Health & Healing
-
-
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 21 years or more
- Pain at least once a week in one or both hips
- Difficulty with at least one of the following secondary to hip pain: walking 1/4 mile, climbing stairs, getting in and out of a car, rising from a chair, lifting and carrying groceries, getting out or bed, getting out of the bathtub, or performing shopping, cleaning or self-care activities
- Radiographic evidence of femoral and/or acetabular osteophytes on radiograph -OR- radiographic evidence of axial joint space narrowing and active hip flexion </= 115 degrees
- Primary care physician's written consent to participate in the exercise-based protocol. If te subject does not have a primary care physician, the subject will complete a screening questionnaire for coronary artery disease. If the subject screens as "high risk", te subject will be excluded from the study
Exclusion Criteria:
- A medical condition that precludes safe participation in an exercise program including active cardiac disease, angina, class III heart failure, myocardial infarction in the past year
- Screening as "high risk" for coronary artery disease
- Inflammatory arthritis (e.g. psoriatic or rheumatoid)
- Collecting workers' compensation
- Involved in litigation regarding pain and/or disability
- Unable to walk six minutes without cane or assistive device
- Participating in a conflicting research study
- Significant, symptomatic knee or ankle osteoarthritis
- Other lower extremity pathology including peripheral vascular disease that would preclude participation in an exercise program
- Pregnancy
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Waitlist Control
Delayed intervention.
3 months on waitlist, crossover to intervention (3 additional months)
|
Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months.
When an opening becomes available, the subject will begin the exercise program identical to that of Group 2
Other Names:
|
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Experimental: 3 Month Exercise Program
3 month exercise program
|
Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program.
The intervention will consist of two phases and take place at OHSU rehabilitation services.
Phase 1 will be a two-week orientation and general conditioning program.
Phase 2 will be a ten-week progressive workload program.
Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session.
Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors.
Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 6-minute Walk Test
Time Frame: 3 months
|
Calculated as change from baseline to 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Visual Analog Scale
Time Frame: 3 months
|
Evaluated using a 100mm pain VAS (range 0-100), with higher scores indicating worse pain.
Calculated as change from baseline to 3 months.
|
3 months
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
Time Frame: 3 months
|
The WOMAC Physical Function Subscale has a range of 0-68, with higher scores indicating worse functional limitations.
Calculated as change from baseline to 3 months.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nels Carlson, M.D., Oregon Health and Science University
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.
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)
May 23, 2007
Primary Completion (Actual)
November 11, 2010
Study Completion (Actual)
November 11, 2010
Study Registration Dates
First Submitted
May 20, 2008
First Submitted That Met QC Criteria
May 21, 2008
First Posted (Estimate)
May 22, 2008
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 11, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #290
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