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

NCT04070027 | Active Not Recruiting

• 7 other identifiers: S-20180158R153-A4771R161-A5280R166-A5553R176-A623118/4199417/33622
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Hip Osteoarthritis

Keywords

Total Hip Arthroplasty; Total Hip Replacement; Exercise; Progressive Resistance Training; Strength Training; Hip Joint

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale from baseline to 6 months

  6 months

• Change in the HOOS symptoms subscale from baseline to 6 months

  6 months

• Change in the HOOS activities of daily living (ADL) function subscale from baseline to 6 months

  6 months

• Change in the HOOS quality-of-life subscale from baseline to 6 months

  6 months

• Change in the HOOS sports and recreation subscale from baseline to 6 months

  6 months.

Other Outcomes (14)

• Change in hip pain intensity on a 101-point Visual Analogue Scale (VAS) from baseline to 6 months

  6 months

• Change in EuroQol Group 5-dimension 5-level (EQ-5D-5L) from baseline to 6 months

  6 months

• Change in number of patients using pain medication related to the hip from baseline to 6 months

  6 months

Study Arms (2)

Total Hip Arthroplasty

ACTIVE COMPARATOR

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

Progressive Resistance Training

ACTIVE COMPARATOR

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

Interventions

Total Hip Arthroplasty PROCEDURE

Total hip arthroplasty following standard procedures.

Also known as: Total Hip Replacement

Total Hip Arthroplasty

Progressive Resistance Training 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.

Also known as: Strength Training, Exercise

Progressive Resistance Training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Severe walking deficits (dependency of two crutches or walker)
• Body Mass Index \>35 kg/m2
• 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).

Sponsors & Collaborators

• Vejle Hospital: lead
• Odense University Hospital: collaborator
• Naestved Hospital: collaborator
• Aarhus University Hospital: collaborator
• The Danish Rheumatism Association: collaborator
• Region of Southern Denmark: collaborator
• Association of Danish Physiotherapists: collaborator
• The Research Council at Naestved-Slagelse-Ringsted Hospitals: collaborator

Study Sites (4)

Department of Orthopaedic Surgery, Aarhus University Hospital (AUH)

Aarhus, 8200, Denmark

Location

Department of Orthopaedic Surgery, Naestved Hospital

Næstved, 4700, Denmark

Location

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

Odense, 5000, Denmark

Location

Depatment of Orthopaedic Surgery, Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (4)

• 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.

  PMID: 41141645 DERIVED

• 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.

  PMID: 39476341 DERIVED

• 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.

  PMID: 37094895 DERIVED

• 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.

  PMID: 34686555 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Motor Activity

Interventions

Arthroplasty, Replacement, Hip; Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Thomas Frydendal, PT, MSc

  Vejle Hospital and University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Søren Overgaard, Prof., MD

  Odense University Hospital and University of Southern Denmark

  STUDY DIRECTOR

• Inger Mechlenburg, Prof., DMSc

  Aarhus University Hospital and Aarhus University

  STUDY CHAIR

• Kim Gordon Ingwersen, PT, PhD

  Vejle Hospital and University of Southern Denmark

  STUDY CHAIR

• Lone Ramer Mikkelsen, PT, PhD

  Silkeborg Regional Hospital

  STUDY CHAIR

• Robin Christensen, Prof., PhD

  The Parker Institute and Odense University Hospital

  STUDY CHAIR

• Claus Varnum, PhD, MD

  Vejle Hospital

  STUDY CHAIR

• Henrik Morville Schrøder, PhD, MD

  Naestved Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 28, 2019
• Study Start: September 2, 2019
• Primary Completion: May 5, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after publication of the trial.
• Access Criteria: Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.

Locations

DK (4)