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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. Long-term Follow-up of a Prospective, Randomized Controlled Intervention Study.

Brief 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-interventio

Detailed Summary:

Aims

Aim 1 To evaluate the long-term effects of a patient education program and a 12 week exercise therapy program (IG) compared to patient education only (CG) on hip function, quality of life and physical function in patients with hip OA not eligible for total hip arthroplasty (THA) at time of inclusion Aim 2

  1. To examine differences in radiographic changes between those individuals who went through a patient education program and a 12 week exercise therapy program (IG) compared to those who only went through a patient education program (CG) 2 years after inclusion.
  2. To examine predictive factors for radiographic changes and changes in hip function at a 2 year follow-up after inclusion.

Aim 3

  1. To evaluate hip function, quality of life and physical function in those patients who have gone through total hip arthroplasty (THA)
  2. To examine differences in hip function, quality of life, and physical function in patients who prior to surgery went through a patient education program and a 12 week exercise therapy program (IG) compared those patients who went through a patient education program only (CG) 6 months after THA.

Material and methods

Design:

This study is a prospective, randomized clinical trial examining the long term effect of two different interventions for patients with hip OA. The long term follow-up is based on an ongoing study (03a-2005-NAR) on short term outcome.

Patients:


Sponsor: Ullevaal University Hospital

Current Primary Outcome: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SF-36 (quality of life) [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ]
  • PASE (activity score) [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ]
  • Self-efficacy for pain [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ]
  • Muscle strength tests [ Time Frame: Baseline, 12 weeks, 6 and 24 months. ]
  • 6 minute walk test [ Time Frame: Baseline, 12 weeks, 6 and 24 months. ]
  • Åstrand's bike test [ Time Frame: Baseline, 12 weeks, 6 and 24 months. ]
  • Range of motion [ Time Frame: Baseline, 12 weeks, 6 and 24 months. ]
  • Radiographic examination [ Time Frame: Baseline and 24 months. ]


Original Secondary Outcome: Same as current

Information By: Oslo University Hospital

Dates:
Date Received: February 4, 2010
Date Started: January 2009
Date Completion: December 2013
Last Updated: August 17, 2012
Last Verified: August 2012