Overview

This trial is active, not recruiting.

Condition hip osteoarthritis
Treatments a 12 week supervised exercise program and patient education, patient education
Sponsor Oslo University Hospital
Start date March 2005
End date May 2013
Trial size 109 participants
Trial identifier NCT01338532, 03c-2011-NAR

Summary

The purpose of this study is to evaluate the time to total hip replacement in patients with hip osteoarthritis going through both a supervised exercise program and patient education compared to patients going through patient education only.

The null hypothesis is: There are no differences in time to total hip replacement between patients with hip osteoarthritis who went through a 12 week supervised exercise program and patient education compared to patients who went through patient education only.

Material and methods:

109 patients with both symptomatically and radiographically verified hip osteoarthritis were included in this randomized controlled trial between april 2005 and october 2007. They were randomized to either a 12 week supervised exercise program and patient education (n=55) or patient education only (n=54).

Information on if and when total hip replacement is performed will be collected between April 1st and May 1st. Time since inclusion to follow-up will range from 3.5 to 6 years. Data will be collected directly from the study participants by telephone.

The main outcome is time to total hip replacement.

Status:

This study is a prolongation of an on-going RCT (3a-2005-NAR) using clinical outcomes to evaluate the effect of supervised exercise and patient education.

The study will be carried out: NAR-Department of Orthopedics, Ullevaal University Hospital.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
a 12 week supervised exercise program and patient education
The exercise protocol included 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 was required to exercise for approximately 60 minutes, to-three days a week for 12 weeks. Patient's attendance to the exercise program (compliance) was registered. All patients included in the study participated in a patient education program which included two individual and three small-group sessions lasting one hour each time.
(Active Comparator)
patient education
All patients included in the study participated in a patient education program which included two individual and three small-group sessions lasting one hour each time.

Primary Outcomes

Measure
Time to Total Hip Replacement surgery (THR)
time frame: 3.5 to 6 years after inclusion

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Between 40 and 80 years old with uni- or bilateral hip disability. - Hip pain for more then 3 months. - Harris Hip Score between 60 and 95. Harris Hip score (0-100 points) is widely used as an assessment of hip function in patients with hip OA. Harris Hip Score of 60 or below are used regularly at our institution as one of the criteria for total hip replacement surgery. - Radiographic verified hip OA (Danielsson's criteria for radiographic OA: Danielsson's criteria for minimal joint space: < 4 mm < 70 years, < 3 mm ≥ 70 years, or 1 mm difference between hips). Exclusion Criteria: - Patients who have a history of resent trauma or functional impairment to the lower limbs or diseases which might interfere with participation (rheumatoid arthritis, cancer, osteoporosis, severe back pain, knee OA). - Patients with co-morbidities not tolerating physical activities

Additional Information

Official title Time to Total Hip Replacement in Patients With Hip Osteoarthritis Going Through Both Supervised Exercise and Patient Education Compared to Those Going Through Patient Education Only. A 3.5-6 Year Follow-up of a Randomized, Controlled, Clinical Trial.
Principal investigator May Arna Risberg, PT, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Oslo University Hospital.