Clinical trial NCT04070027: Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With Hip Osteoarthritis
Official title: Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With End-stage Hip Osteoarthritis (PROHIP): A Multicentre, Parallel-group, Randomised Controlled Superiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Total Hip Arthroplasty
Total Hip Replacement
Exercise
Progressive Resistance Training
Strength Training
Hip Joint
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Naestved Hospital
name: Aarhus University Hospital
name: The Danish Rheumatism Association
name: Region of Southern Denmark
name: Association of Danish Physiotherapists
name: The Research Council at Naestved-Slagelse-Ringsted Hospitals
First posted: 2019-08-28
Enrollment: 109
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Change in the Oxford Hip Score (OHS) from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale from baseline to 6 months
timeFrame: 6 months
measure: Change in the HOOS symptoms subscale from baseline to 6 months
timeFrame: 6 months
measure: Change in the HOOS activities of daily living (ADL) function subscale from baseline to 6 months
timeFrame: 6 months
measure: Change in the HOOS quality-of-life subscale from baseline to 6 months
timeFrame: 6 months
measure: Change in the HOOS sports and recreation subscale from baseline to 6 months
timeFrame: 6 months.
measure: Change in the University of California Los Angeles (UCLA) Activity Score
timeFrame: 6 months
measure: Change in the 40 metre Fast Paced Walk Test (40m-FPWT) from baseline to 6 months
timeFrame: 6 months
measure: Change in the 30 second Chair Stand Test (30s-CST) from baseline to 6 months
timeFrame: 6 months
measure: Number of Serious Adverse Events (SAE) from baseline to 6 months
timeFrame: 6 months.
Other outcomes:
measure: Change in hip pain intensity on a 101-point Visual Analogue Scale (VAS) from baseline to 6 months
timeFrame: 6 months
measure: Change in EuroQol Group 5-dimension 5-level (EQ-5D-5L) from baseline to 6 months
timeFrame: 6 months
measure: Change in number of patients using pain medication related to the hip from baseline to 6 months
timeFrame: 6 months
measure: Global Perceived Effect (GPE) at 6 months
timeFrame: 6 months
measure: Patient Acceptable Symptom State (PASS) at 6 months
timeFrame: 6 months
measure: Treatment Failure at 6 months
timeFrame: 6 months
measure: Change in physical activity (tri-axial accelerometer) from baseline to 6 months
timeFrame: 6 months
measure: Change in isometric hip muscle strength from baseline to 6 months
timeFrame: 6 months
measure: Number of total hip arthroplasty surgeries from baseline to 6 months (PRT group)
timeFrame: 6 months
measure: Number of PRT sessions from baseline to 3 months (PRT group)
timeFrame: 3 months
measure: Change in training load from baseline to 3 months (PRT group)
timeFrame: 3 months
measure: Number of patients performing unsupervised exercise from 3 to 6 months (PRT group)
timeFrame: 3 months
measure: Number of patients receiving supervised postoperative rehabilitation from baseline to 6 months (THA group)
timeFrame: 6 months
measure: Number of patients receiving other treatments from baseline to 6 months.
timeFrame: 6 months
Locations:
city: Aarhus
country: Denmark
facility: Department of Orthopaedic Surgery, Aarhus University Hospital (AUH)
city: Næstved
country: Denmark
facility: Department of Orthopaedic Surgery, Naestved Hospital
city: Odense
country: Denmark
facility: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital (OUH)
city: Vejle
country: Denmark
facility: Depatment of Orthopaedic Surgery, Vejle Hospital
Study officials:
affiliation: Vejle Hospital and University of Southern Denmark
name: Thomas Frydendal, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital and University of Southern Denmark
name: Søren Overgaard, Prof., MD
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital and Aarhus University
name: Inger Mechlenburg, Prof., DMSc
role: STUDY_CHAIR
affiliation: Vejle Hospital and University of Southern Denmark
name: Kim Gordon Ingwersen, PT, PhD
role: STUDY_CHAIR
affiliation: Silkeborg Regional Hospital
name: Lone Ramer Mikkelsen, PT, PhD
role: STUDY_CHAIR
affiliation: The Parker Institute and Odense University Hospital
name: Robin Christensen, Prof., PhD
role: STUDY_CHAIR
affiliation: Vejle Hospital
name: Claus Varnum, PhD, MD
role: STUDY_CHAIR
affiliation: Naestved Hospital
name: Henrik Morville Schrøder, PhD, MD
role: STUDY_CHAIR
References:
citation: 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.