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Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured exercise program
Waitlist, delayed intervention
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip, osteoarthritis, exercise, disability, physical function

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Health & Science University Center for Health & Healing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Waitlist Control

3 Month Exercise Program

Arm Description

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

3 month exercise program

Outcomes

Primary Outcome Measures

Change in 6-minute Walk Test
Calculated as change from baseline to 3 months

Secondary Outcome Measures

Change in Pain Visual Analog Scale
Evaluated using a 100mm pain VAS (range 0-100), with higher scores indicating worse pain. Calculated as change from baseline to 3 months.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
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.

Full Information

First Posted
May 20, 2008
Last Updated
March 11, 2020
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00682617
Brief Title
Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability
Official Title
Hip Osteoarthritis: Effects of Structured Exercise Programs on Pain and Long-term Disability
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2007 (Actual)
Primary Completion Date
November 11, 2010 (Actual)
Study Completion Date
November 11, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
hip, osteoarthritis, exercise, disability, physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist Control
Arm Type
Experimental
Arm Description
Delayed intervention. 3 months on waitlist, crossover to intervention (3 additional months)
Arm Title
3 Month Exercise Program
Arm Type
Experimental
Arm Description
3 month exercise program
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise program
Other Intervention Name(s)
Group 2
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist, delayed intervention
Other Intervention Name(s)
Group 1
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in 6-minute Walk Test
Description
Calculated as change from baseline to 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Pain Visual Analog Scale
Description
Evaluated using a 100mm pain VAS (range 0-100), with higher scores indicating worse pain. Calculated as change from baseline to 3 months.
Time Frame
3 months
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nels Carlson, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University Center for Health & Healing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31600429
Citation
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.
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Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability

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