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

Hip Osteoarthritis Clinical Trial

— PROHIP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04070027
• Other study ID #: S-20180158
• Secondary ID: R153-A4771R161-A
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: June 2026
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Total Hip Arthroplasty
Total hip arthroplasty following standard procedures.

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Department of Orthopaedic Surgery, Aarhus University Hospital (AUH)	Aarhus
Denmark	Department of Orthopaedic Surgery, Naestved Hospital	Næstved
Denmark	Department of Orthopaedic Surgery and Traumatology, Odense University Hospital (OUH)	Odense
Denmark	Depatment of Orthopaedic Surgery, Vejle Hospital	Vejle

Sponsors (8)

Lead Sponsor	Collaborator
Vejle Hospital	Aarhus University Hospital, Association of Danish Physiotherapists, Naestved Hospital, Odense University Hospital, Region of Southern Denmark, The Danish Rheumatism Association, The Research Council at Naestved-Slagelse-Ringsted Hospitals

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in hip pain intensity on a 101-point Visual Analogue Scale (VAS) from baseline to 6 months	The VAS pain is a single-item patient-reported outcome measure used to assess mean hip pain intensity at rest, and main hip pain intensity activity during the previous 24 hours. The total scale ranges from 0 (no pain) to 100 (worst pain imaginable).	6 months
Other	Change in EuroQol Group 5-dimension 5-level (EQ-5D-5L) from baseline to 6 months	The EQ-5D-5L is a five-item patient-reported outcome measure designed to assess generic health-related quality-of-life. The total score of the descriptive index and EQ-VAS ranges from -0.624 (worst) to 1.000 (best) and 0 (worst imaginable health) to 100 (best imaginable health), respectively. This will also allow for a later cost-utility analysis.	6 months
Other	Change in number of patients using pain medication related to the hip from baseline to 6 months	Medicine consumption will be assessed with the following question: "Have you been taking pain medication within the last week?" on a dichotomous scale (yes/no). Patients answering "yes" will be asked to provide type of medication on a categorical scale (Paracetamol, NSAID, morphine/opioids, Gabapentin, and other), frequency on 6-point Likert-scale ranging from "1 time a week" to "4 times a day or above", and asked "Have you primarily been taking pain medication due to your hip?" rated on a dichotomous scale (yes/no). Patients responding "no" to the latter question will be asked "If no, have you been taking pain medication due to other known diseases or disorders?" rated on on a dichotomous scale (yes/no).	6 months
Other	Global Perceived Effect (GPE) at 6 months	The GPE of the interventions will be assessed for seven domains, including overall hip problems, hip pain, hip symptoms, ADL function, sports and recreation, hip-related quality-of-life, and physical activity on a 15-point Likert scale ranging from "a very great deal worse" (worst) to "a very great deal better" (best).	6 months
Other	Patient Acceptable Symptom State (PASS) at 6 months	PASS will be assessed with the following question: "When you think of your hip function, will you consider your current condition as satisfying?" By hip function, you should take into account your activities of daily living, sport and recreational activities, your hip pain and other symptoms and your quality-of-life on a dichotomous scale (yes/no).	6 months
Other	Treatment Failure at 6 months	Patient-reported treatment failure will be assessed only by patients answering "no" to PASS with the following question: "Would you consider your current state as being so unsatisfactory that you think the treatment has failed?" on a dichotomous scale (yes/no).	6 months
Other	Change in physical activity (tri-axial accelerometer) from baseline to 6 months	Physical activity will be recorded with a tri-axial accelerometer (AX3, Axivity, Ltd., Newcastle, UK) mounted on the lateral thigh during a 7 day period. Data will be post-processed using a custom designed algorithm (MATLAB, Mathworks, Natick, MA, USA).	6 months
Other	Change in isometric hip muscle strength from baseline to 6 months	Isometric muscle strength of the index hip will be recorded for hip extension, flexion, and abduction with a handheld dynamometer (Commander Echo Wireless Console and Muscle Tester, JTECH Medical, Salt Lake City, Utah, USA) and reported as Newton meters per kilogram of the bodyweight (Nm/kg).	6 months
Other	Number of total hip arthroplasty surgeries from baseline to 6 months (PRT group)	Number of total hip arthroplasty surgeries performed in the PRT group will be registered through a medical record review.	6 months
Other	Number of PRT sessions from baseline to 3 months (PRT group)	In the PRT group, the number of PRT sessions participated in by the patient will be registered by the supervising physiotherapist. High compliance will be defined as participation in =75% of the training sessions corresponding to 18 out of 24 sessions; moderate compliance as participation in 50-74% of the sessions; and poor compliance as participation in <50% of the sessions.	3 months
Other	Change in training load from baseline to 3 months (PRT group)	Training load of each exercise in the PRT group will be registered by the supervising physiotherapist and reported as kilogram (kg).	3 months
Other	Number of patients performing unsupervised exercise from 3 to 6 months (PRT group)	Following the 12-week supervised PRT program, adherence to three-months of optional unsupervised PRT will be measured by a patient-reported questionnaire.	3 months
Other	Number of patients receiving supervised postoperative rehabilitation from baseline to 6 months (THA group)	Participation in postoperative supervised exercise in the THA group will be assessed using a patient-reported questionnaire.	6 months
Other	Number of patients receiving other treatments from baseline to 6 months.	Other treatments related to the index hip will be assessed using a patient-reported questionnaire.	6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.