Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. Long-term Follow-up.

NCT01063777 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2012-08-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the long term effect of exercise therapy and patient education compared to patient education only in individuals with hip OA, and to evaluate predictive factors for changes in hip osteoarthritis both clinically and on x-ray.

Main hypothesis H01: There are no significant long term ( 2 years) differences in hip function, quality of life, physical function and radiological changes between those individuals who went through a patient education program and a 12 week exercise therapy program compared to patient education program only.

Material and Methods:

109 patients with radiographically verified hip OA are included in the randomized controlled trial; randomized to 12 week exercise therapy program and patient education (n=55) and patient education program only (n=54).

Data will be collected 2 years after completed intervention period in the original RCT, and 6 months and 2 years postoperatively for those patients who have undergone total hip arthroplasty.

The main outcome is:

The Disease Specific WOMAC-Index.

Secondary outcome measures are:

Hip X-ray, SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, isokinetic muscle strength tests, 6 minute walk test, Åstrand's bike test, range of motion.

Status:

This study is a prolongation of an on-going RCT (3a-2005-NAR). The inclusion, intervention and follow-ups including 1 year follow-up is completed. 2 year post-intervention follow-up will be completed in 2010, 2 year follow-up postoperative for patients undergoing total hip artroplasty will continue throughout 2011.

The study will be carried out: NAR-Orthopedic Centre, Ullevaal University Hospital.

Conditions

  • Hip Osteoarthritis

Interventions

OTHER

A 12 week exercise therapy program and patient education.

The exercise protocol includes exercises from former studies on comparable patient populations. The intensity of the strength- and flexibility exercises meets the American College of Sports Medicine's (ACSM) recommendations for developing and maintaining muscular fitness in adults.Patients will be required to exercise for 60 minutes, three days a week for 12 weeks. Patient's attendance to the exercise program (compliance) will be registered by the physical therapists. All patients included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time.

OTHER

Patient education

All patients included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time.

Sponsors & Collaborators

  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • May Arna Risberg, PT, PhD · NAR- Orthopedic Centre, Ullevål University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063777 on ClinicalTrials.gov