Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Supervised exercise; Other: Patient education

• Registration Number: NCT01697241
• Lead Sponsor: University of Southern Denmark

Brief Summary

The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis postpone time to hip replacement surgery following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone.

Detailed Description

Hip replacements are performed at an increasing rate, also in younger and less disabled patients. Recent studies indicate non-surgical interventions being effective in reducing pain and disability also at later stages of disease when hip replacement is considered. Possible, non-surgical treatments can be used to postpone hip replacement. The effect of education and supervised exercise on time to hip replacement is largely unknown

Study Timeline

• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-10-02
• Study Start: 2013-05
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 40 years and older
• Indication for total hip arthroplasty
• Residency within local municipal or willing to commute

Exclusion Criteria

• Inflammatory joint disease
• Earlier ipsilateral proximal femur fracture
• Hip pain < 3 months
• Neuropathy or neuromuscular disease
• Malignant disease
• Diseases where a moderate level of physical exercise is contraindicated
• Unable to speak or read Danish
• Unable to participate for other reasons
• Refuse to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised exercise and patient education	Supervised exercise	The entire duration of the intervention is 12 weeks, and consists of 24 sessions each lasting 60-70 minutes. Patients will receive two types of exercises, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX) in groups with progression guided by the patient's neuromuscular function (12 sessions). The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load (12 sessions).
Patient Education	Patient education	The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration
Supervised exercise and patient education	Patient education	The entire duration of the intervention is 12 weeks, and consists of 24 sessions each lasting 60-70 minutes. Patients will receive two types of exercises, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX) in groups with progression guided by the patient's neuromuscular function (12 sessions). The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load (12 sessions).

Primary Outcome Measures

Name	Time	Method
Cumulative Survival analysis (Kaplan-Maier survival curve)	one year	Cumulative Survival analysis as time in days without surgery since inclusion

Secondary Outcome Measures

Name	Time	Method
The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)	Baseline, 3 and 12 months	HOOS is patient-reported outcome measure with 5 subscales for pain, other symptoms, function in daily living, function in sport and recreation and hip related Quality of Life. A 5-point Likert-scale is used and converted into a 100-point scale with zero indicating the worst possible health (http://www.koos.nu).
University of California Los Angeles activity score (UCLA)	Baseline, 3 and 12 months	Physical activity levels in populations. UCLA is a 10-point likert scale recommended and used extensively in similar populations
Global perceived effect (GPE) score	3 and 12 months	Patients will be asked to rate possible change in their pain, symptoms, ADL, sports and recreation, quality of life, level of physical activity since the initial administration (baseline) on a 7-point Likert-scale.

Trial Locations

Locations (2)

Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark; 🇩🇰 Odense, Denmark

Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark; 🇩🇰 Vejle, Denmark