|
|
View Clinical Trial (Medical Research Study)
|
Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability - NCT00682617-97239 (Clinical Trial 222503)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy222503.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Portland |
|
State:
|
|
OR |
| Zip Code: |
|
97239 |
| Conditions: |
|
Hip Osteoarthritis |
| Purpose: |
|
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 summary: |
|
|
| Criteria: |
|
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 is available at: |
|
Oregon Health & Science University Center for Health & Healing
Portland, OR 97239
United States
Primary Contact:
Elizabeth Arnall
Email: arnalle@ohsu.edu
Phone: 503-494-6992 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|