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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2026-06-30

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.

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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.

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Total Hip Arthroplasty

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).

Group Type ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type PROCEDURE

Total hip arthroplasty following standard procedures.

Progressive Resistance Training

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.

Group Type ACTIVE_COMPARATOR

Progressive Resistance Training

Intervention Type OTHER

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.

Interventions

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Total Hip Arthroplasty

Total hip arthroplasty following standard procedures.

Intervention Type PROCEDURE

Progressive Resistance Training

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.

Intervention Type OTHER

Other Intervention Names

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Total Hip Replacement Strength Training Exercise

Eligibility Criteria

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Inclusion Criteria

1. Adults aged ≥50 years
2. 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
3. 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

1. Severe walking deficits (dependency of two crutches or walker)
2. Body Mass Index \>35 kg/m2
3. Lower extremity fractures within one-year prior to inclusion
4. Planned other lower extremity surgery within six months
5. Cancer diagnosis and receiving chemo-, immuno- or radiotherapy
6. Neurological diseases (e.g. previous stroke, multiple sclerosis, Parkinson's, Alzheimer's).
7. 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.).

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Frydendal, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Vejle Hospital and University of Southern Denmark

Søren Overgaard, Prof., MD

Role: STUDY_DIRECTOR

Odense University Hospital and University of Southern Denmark

Inger Mechlenburg, Prof., DMSc

Role: STUDY_CHAIR

Aarhus University Hospital and Aarhus University

Kim Gordon Ingwersen, PT, PhD

Role: STUDY_CHAIR

Vejle Hospital and University of Southern Denmark

Lone Ramer Mikkelsen, PT, PhD

Role: STUDY_CHAIR

Silkeborg Regional Hospital

Robin Christensen, Prof., PhD

Role: STUDY_CHAIR

The Parker Institute and Odense University Hospital

Claus Varnum, PhD, MD

Role: STUDY_CHAIR

Vejle Hospital

Henrik Morville Schrøder, PhD, MD

Role: STUDY_CHAIR

Naestved Hospital

Locations

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Department of Orthopaedic Surgery, Aarhus University Hospital (AUH)

Aarhus, , Denmark

Site Status

Department of Orthopaedic Surgery, Naestved Hospital

Næstved, , Denmark

Site Status

Department of Orthopaedic Surgery and Traumatology, Odense University Hospital (OUH)

Odense, , Denmark

Site Status

Depatment of Orthopaedic Surgery, Vejle Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

References

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Bryld ES, Christiansen L, Ingwersen KG, Overgaard S, Mikkelsen LR, Mechlenburg I, Frydendal T. Training load and pain response during progressive resistance training in patients with hip osteoarthritis in the PROHIP trial. Osteoarthr Cartil Open. 2025 Oct 4;7(4):100690. doi: 10.1016/j.ocarto.2025.100690. eCollection 2025 Dec.

Reference Type DERIVED

PMID: 41141645 (View on PubMed)

Frydendal T, Christensen R, Mechlenburg I, Mikkelsen LR, Varnum C, Graversen AE, Kjaersgaard-Andersen P, Revald PH, Hofbauer C, Bieder MJ, Qassim H, Munir MS, Jakobsen SS, Nielsen SM, Ingwersen KG, Overgaard S. Total Hip Replacement or Resistance Training for Severe Hip Osteoarthritis. N Engl J Med. 2024 Oct 31;391(17):1610-1620. doi: 10.1056/NEJMoa2400141.

Reference Type DERIVED

PMID: 39476341 (View on PubMed)

Frydendal T, Thomsen KS, Mechlenburg I, Mikkelsen LR, Overgaard S, Ingwersen KG, Myburgh C. Patient and public involvement to inform the protocol of a clinical trial comparing total hip arthroplasty with exercise: an exploratory qualitative case study. BMJ Open. 2023 Apr 24;13(4):e070866. doi: 10.1136/bmjopen-2022-070866.

Reference Type DERIVED

PMID: 37094895 (View on PubMed)

Frydendal T, Christensen R, Mechlenburg I, Mikkelsen LR, Overgaard S, Ingwersen KG. Total hip arthroplasty versus progressive resistance training in patients with severe hip osteoarthritis: protocol for a multicentre, parallel-group, randomised controlled superiority trial. BMJ Open. 2021 Oct 22;11(10):e051392. doi: 10.1136/bmjopen-2021-051392.

Reference Type DERIVED

PMID: 34686555 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan: Statistical Analysis Plan: RCT

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan: Generalizability

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan: Physical Activity

View Document