Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With Hip Osteoarthritis

Study Overview
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Brief Summary
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Hip osteoarthritis is associated with joint pain, physical disability, decreased muscle strength and poor health status, and the most common cause for total hip arthroplasty. No studies have investigated the effect of total hip arthroplasty compared to non-surgical treatment in patients with end-stage hip osteoarthritis. This comparison is of upmost importance as it is unknown whether non-surgical treatment may be used as an alternate to surgery. The purpose of this study is to investigate whether total hip arthroplasty followed by standard care is superior to progressive resistance training for improving hip function and pain in patients with end-stage hip osteoarthritis. The hypothesis is that patients treated with total hip arthroplasty will improve more than patients treated with progressive resistance training.

Detailed Description
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Hip osteoarthritis (OA) is associated with joint pain, dysfunction of activities of daily living (ADL), decreased muscle strength and decline in health-related quality of life status, and the most common cause for total hip arthroplasty (THA). In Denmark, approximately 10.400 primary THA surgeries are performed annually, and the yearly incidence rate of this procedure has increased dramatically from 80 to 180 per 100.000 persons between 1995 and 2016. However, some patients experience long-term pain and may never recover full physical function and muscle strength after surgery. Exercise has been shown to improve physical function and reduce pain in people with hip OA, and is recommended initially as a treatment in international clinical guidelines. Furthermore, a recent randomised controlled trial (RCT) showed clinically relevant improvements in ADL and muscle function after 10-weeks of supervised explosive-type progressive resistance training (PRT) in patients with end-stage hip OA scheduled for THA compared to standard preoperative care. To date, no RCTs have investigated the effect of THA followed by standard postoperative care compared to supervised explosive-type PRT in patients with end-stage hip OA. Therefore, this highlights the need for a high-quality trial as it is unknown whether non-surgical treatment may be used as an alternate to surgery. The aim of this randomised controlled trial is to investigate whether THA followed by standard care is superior to a 12-week supervised explosive-type PRT programme for improving patient-reported hip function and pain 6 months after initiating the intervention, measured using the Oxford Hip Score (OHS), in patients with end-stage hip OA eligible for THA. Exploratory outcome time-points will be assessed at 3, 12, 24 and 60 months after initiating the intervention. The hypothesis is that THA followed by standard care is superior to a 12-week supervised explosive-type PRT programme for improving patient-reported hip function and pain 6 months after initiating the intervention, measured using the OHS, in patients with end-stage hip OA eligible for THA. Observational cohort: Patients fulfilling the eligibility criteria but declining to participate in the RCT will be asked to participate in a prospective observational cohort study using the same primary end-point (6 months), exploratory time-points (3, 12, 24 and 60 months), and patient-reported outcomes, but following usual clinical practice.

Official Title
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Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With End-stage Hip Osteoarthritis (PROHIP): A Multicentre, Parallel-group, Randomised Controlled Superiority Trial

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty
* Other: Progressive Resistance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged ≥50 years Clinical history and symptoms consistent with primary hip osteoarthritis (including hip osteoarthritis due to mild hip dysplasia that may be treated with standard components) and radiographic verified hip osteoarthritis defined as joint space narrowing <2 mm Considered eligible for total hip arthroplasty by an orthopaedic surgeon (i.e. duration of symptoms >3 months, hip related pain, functional impairment or decreased range of motion (ROM), and attempted treatment with analgesics) Exclusion Criteria: Severe walking deficits (dependency of two crutches or walker) Body Mass Index >35 kg/m2 Lower extremity fractures within one-year prior to inclusion Planned other lower extremity surgery within six months Cancer diagnosis and receiving chemo-, immuno- or radiotherapy Neurological diseases (e.g. previous stroke, multiple sclerosis, Parkinson's, Alzheimer's). Other reasons for exclusion (i.e. inadequacy in written and spoken Danish, mentally unable to participate, physically unable to comply with the PRT protocol due to comorbidity (e.g. severe heart disease, previous major lower extremity surgery within six-months) etc.).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Hip Arthroplasty<br>A standard fast-track multimodal surgical program comprising patient information, optimised pain management, and early mobilisation. Total hip arthroplasty (THA) will be performed by experienced orthopaedic surgeons in accordance with the standard posterior surgical approach. Patients will receive standard postoperative rehabilitation consisting of either a standard leaflet with a hospital-specific home-based exercise program aimed at increasing hip muscle strength and range of motion or, if considered necessary, a referral to supervised hip-specific exercise therapy delivered at private physiotherapist clinics or municipal rehabilitation. Furthermore, postsurgical procedures will follow hospital-specific procedures ranging from no postsurgical control to postsurgical assessment of the hip and rehabilitation at the physiotherapy department (after six-weeks). | Procedure: Total Hip Arthroplasty<br>* Total hip arthroplasty following standard procedures.<br>* Other names: Total Hip Replacement;|
| Active Comparator: Progressive Resistance Training<br>A 12-week supervised explosive-type progressive resistance training (PRT) program with two training sessions a week. All training sessions will be conducted in municipal rehabilitation centres with one-to-one supervision and ≥48 hours of rest in between sessions. The standardised PRT program will consist of warm-up on a stationary bicycle (10 min) followed by four lower extremity exercises (50 min). Exercises will be performed unilaterally with as full range of motion as possible in sets of three separated by 60 sec of rest in the following order: leg press, hip extension, hip flexion, and hip abduction. Patients will be instructed to complete the concentric phase of each repetition as fast as possible, maintain full extension for 1 sec, and perform the eccentric phase in 2-3 sec. Hip-related pain up to 5 rated on a Numerical Rating Scale (0-10) is considered acceptable during exercises. After the 12-weeks, patients will be offered three-months of optional unsupervised PRT. | Other: Progressive Resistance Training<br>* Progressive resistance training based on available evidence on patients with hip osteoarthritis and designed in accordance with the American College of Sports Medicine (ACSM) recommendations for progression models in resistance training aiming at inducing muscle hypertrophy and increasing muscle strength and power.<br>* Other names: Exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Oxford Hip Score (OHS) from baseline to 6 months | The OHS is a 12-item patient-reported outcome measure designed to assess hip function and pain within the last four weeks among patients suffering from hip osteoarthritis in one score. The total score ranges from 0 to 48, with higher scores indicating better disease status. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale from baseline to 6 months | The HOOS pain subscale is a 10-item patient-reported outcome measure designed to assess hip pain in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better pain status. | 6 months | 
| Change in the HOOS symptoms subscale from baseline to 6 months | The HOOS pain subscale is a five-item patient-reported outcome measure designed to assess other hip symptoms in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better symptoms status. | 6 months | 
| Change in the HOOS activities of daily living (ADL) function subscale from baseline to 6 months | The HOOS ADL function subscale is a 17-item patient-reported outcome measure designed to assess ADL function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better ADL function status. | 6 months | 
| Change in the HOOS quality-of-life subscale from baseline to 6 months | The HOOS quality-of-life subscale is a four-item patient-reported outcome measure designed to assess hip-related quality-of-life in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better quality-of-life status. | 6 months | 
| Change in the HOOS sports and recreation subscale from baseline to 6 months | The HOOS sports and recreation subscale is a four-item patient-reported outcome measure designed to assess sports and recreation function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better sports and recreation status. | 6 months. | 
| Change in the University of California Los Angeles (UCLA) Activity Score | The UCLA Activity Score is a single-item patient-reported outcome measure designed to assess physical activity level. The score ranges from 1 to 10, with higher scores indicating greater physical activity level. | 6 months | 
| Change in the 40 metre Fast Paced Walk Test (40m-FPWT) from baseline to 6 months | The 40m-FPWT is a physical function test designed to assess short distance maximum walking speed (meters/second). | 6 months | 
| Change in the 30 second Chair Stand Test (30s-CST) from baseline to 6 months | The 30s-CST is a physical function test designed to assess sit-to-stand function (number of repetitions). | 6 months | 
| Number of Serious Adverse Events (SAE) from baseline to 6 months | SAE according to the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines will be collected from The Danish National Patient Registry and medical record review conducted at the 6 months follow-up. Furthermore, a short patient-reported questionnaire at the 3 and 6 months follow-up will be used to ensure that all SAE are recorded. | 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty, Total Hip Replacement, Exercise, Progressive Resistance Training, Strength Training, Hip Joint