Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability - Full Text View

Sponsor:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00682617

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:

MedlinePlus related topics: Exercise and Physical Fitness Osteoarthritis Rehabilitation

U.S. FDA Resources

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:	July 2010
Estimated Primary Completion Date:	December 2009 (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

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

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

Contacts

Contact: Elizabeth Arnall

503-494-6992

arnalle@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, M.D., Oregon Health & Science University
ClinicalTrials.gov Identifier:	NCT00682617 History of Changes
Other Study ID Numbers:	IRB #290
Study First Received:	May 20, 2008
Last Updated:	June 3, 2008
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 February 09, 2012