Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability

NCT00682617 | Completed Results

• 1 other identifier: IRB #290
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hip Osteoarthritis

Keywords

hip; osteoarthritis; exercise; disability; physical function

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute Walk Test

  Calculated as change from baseline to 3 months

  3 months

Secondary Outcomes (2)

• Change in Pain Visual Analog Scale

  3 months

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale

  3 months

Study Arms (2)

Waitlist Control

EXPERIMENTAL

Delayed intervention. 3 months on waitlist, crossover to intervention (3 additional months)

Behavioral: Waitlist, delayed intervention

3 Month Exercise Program

EXPERIMENTAL

3 month exercise program

Behavioral: Structured exercise program

Interventions

Structured exercise program BEHAVIORAL

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.

Also known as: Group 2

3 Month Exercise Program

Waitlist, delayed intervention BEHAVIORAL

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

Also known as: Group 1

Waitlist Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University Center for Health & Healing

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Thompson AR, Christopherson Z, Marshall LM, Carlson HL, Carlson NL. A Pilot Randomized Controlled Trial for Aerobic and Strengthening Exercises on Physical Function and Pain for Hip Osteoarthritis. PM R. 2020 Mar;12(3):229-237. doi: 10.1002/pmrj.12262. Epub 2019 Dec 12.

  PMID: 31600429 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis; Motor Activity

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Nels Carlson
• Organization: Oregon Health & Science University

carlsonn@ohsu.edu

(503) 494-6420

Study Officials

• Nels Carlson, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: May 23, 2007
• Primary Completion: November 11, 2010
• Study Completion: November 11, 2010
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Locations

US (1)