Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Nels Carlson, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00682617
First received: May 20, 2008
Last updated: May 6, 2013
Last verified: May 2013
  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).


Condition Intervention
Hip Osteoarthritis
Behavioral: Structured exercise program
Behavioral: Waitlist, delayed intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Hip Osteoarthritis: Effects of Structured Exercise Programs on Pain and Long-term Disability

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Physical function: 6-minute walk test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain: Visual analog scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Patient Global Assessment: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and The Short Form-36 (SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Joint Imaging: hip radiographs [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Delayed intervention. 3 months on waitlist, crossover to intervention (3 additional months)
Behavioral: Waitlist, delayed intervention
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 Name: Group 1
Experimental: 2
3 month exercise program
Behavioral: Structured 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 Name: Group 2

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682617

Contacts
Contact: Alyssa Lorzano 503-494-6376 lorzano@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Center for Health & Healing Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Nels Carlson, M.D.         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Nels Carlson, M.D. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Nels Carlson, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00682617     History of Changes
Other Study ID Numbers: IRB #290
Study First Received: May 20, 2008
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
hip
osteoarthritis
exercise
disability
physical function

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014