Time to Total Hip Replacement After Supervised Exercise and Patient Education

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.

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.

Study Overview

• Status: Unknown
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Other: A 12 week supervised exercise program and patient education; Other: Patient education

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • NAR-Orthopedic Department, Oslo University Hospital & Hjelp24 NIMI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supervised exercise + patient education	Other: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Total Hip Replacement surgery (THR)	All included patients will be examined regarding if they have gone through THR surgery since their inclusion in the present study. For those who report to have gone through THR surgery, date for when surgery were performed will be collected.	3.5 to 6 years after inclusion

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: May Arna Risberg, PT, PhD, NAR- Department of Orthopedics, Oslo University Hospital

Publications and helpful links

General Publications

• Svege I, Nordsletten L, Fernandes L, Risberg MA. Exercise therapy may postpone total hip replacement surgery in patients with hip osteoarthritis: a long-term follow-up of a randomised trial. Ann Rheum Dis. 2015 Jan;74(1):164-9. doi: 10.1136/annrheumdis-2013-203628. Epub 2013 Nov 19.

Helpful Links

• Homepage NAR

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: April 18, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): August 20, 2012
• Last Update Submitted That Met QC Criteria: August 17, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Exercise; Patient Education; Total Hip Replacement; Hip osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 03c-2011-NAR