Exercise Intervention Targeting Hip Strengthening Compared to Usual Care in Patients Undergoing Revision Hip Replacement

Not Applicable

Active, not recruiting

• Conditions: Revision Total Hip Arthroplasty
• Interventions: Other: Exercise Intervention Targeting Hip Strengthening; Other: Usual Care

• Registration Number: NCT05657054
• Lead Sponsor: University of Aarhus

Brief Summary

There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Further, patients undergoing revision THR achieve worse clinical outcomes on hip pain and function compared to patients undergoing primary THR. The primary aim of this randomized controlled trial is to compare the clinical effectiveness of a partly tele-delivered exercise intervention targeting hip strengthening with the standard community-based rehabilitation (usual care) in patients undergoing revision THR. The investigators will test the hypothesis that the exercise intervention targeting hip strengthening is superior to standard community-based rehabilitation in improving physical function measured with the 30-second Chair Stand Test at 16-week follow-up.

Detailed Description

There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR. Revision THR is one of the more technically challenging orthopedic surgeries and patients undergoing revision THR report improvements in pain and function. Nevertheless, patients undergoing revision THR achieve worse clinical outcomes on hip pain and function compared to patients undergoing primary THR. This calls for research exploring different rehabilitation approaches, in order to improve clinical outcomes for patients after revision THR.

This study aims to compare the clinical effectiveness of a partly tele-delivered exercise intervention targeting hip strengthening with the standard community-based rehabilitation (usual care) in patients undergoing revision THR.

This randomized, controlled, assessor-blinded trial is a multicenter trial involving hospitals and municipality rehabilitation centers across Denmark. Eligible patients undergoing revision THR will be randomized into two groups: A partly remotely-delivered hip strengthening rehabilitation intervention (strength group) or usual care (control group).

The exercise intervention targeting hip strengthening will partly follow the Neuromuscular Exercise (NEMEX) program as described by Eva Ageberg et al., and the intervention is further modified based on expert opinion from patients' experience with rehabilitation from a prior qualitative study. Usual care consists of rehabilitation in the municipalities, where it is up to the individual physiotherapist and the municipality to organize the rehabilitation, which is why both type, content, and duration may vary.

The primary outcome will be change in functional performance measured by the 30-second Chair Stand Test. Outcomes will be measured at baseline, after 16 weeks of intervention, and at 12-month follow-up.

The investigators hypothesize that the exercise intervention targeting hip strengthening is superior to usual care in improving physical function measured with the 30-second Chair Stand Test at 16-week follow-up.

Study Timeline

• Study First Submitted: 2022-11-24
• Study Start: 2022-11-25
• Study First Submitted QC: 2022-12-09
• Study First Posted: 2022-12-20
• Status Verified: 2024-12
• Primary Completion: 2024-12-03
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Patients undergoing first revision THR
• Age ≥ 18 years
• Motivated to participate in an exercise program for 16 weeks
• Provided informed consent to participate
• Patients who has the cup and/or stem replaced or a combination of liner and caput replaced
• Patients who can be baseline tested (chair stand test, stair climb test, 40m walking test)

Exclusion Criteria

• Dependency of wheelchair
• Preplanned other lower limb surgery within 12 months
• Body Mass Index (BMI) score > 40
• Currently undergoing cancer treatment, e.g. chemo-, immuno-, or radiotherapy.
• Comorbidities that prevent exercise
• Inadequacy in written and spoken Danish
• Mentally unable to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strength group	Exercise Intervention Targeting Hip Strengthening	Group 1
Control group	Usual Care	Group 2

Primary Outcome Measures

Name	Time	Method
Change in functional performance measured by the 30-seconds chair stand test	Measured at baseline, 16-week, and 12-month follow-up.	The 30-second chair stand test is a valid and reliable measure of lower-extremity muscle strength evaluating sit-to-stand function, which is limited in people undergoing hip replacement.

Secondary Outcome Measures

Name	Time	Method
Change in the HOOS symptoms subscale	Measured at baseline, 16-week, and 12-month follow-up.	The HOOS symptom 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 symptom status.
Change in the HOOS activities of daily living (ADL) function subscale	Measured at baseline, 16-week, and 12-month follow-up.	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.
Change in 9-step Timed Stair Climb Test (9-step TSCT)	Measured at baseline, 16-week, and 12-month follow-up.	The 9-step TSCT is a physical function test designed to measure lower body strength and balance as well as ascending and descending stair activity and is measured as the time it takes to ascend and descend a 9-step stair.
Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale	Measured at baseline, 16-week, and 12-month follow-up.	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.
Change in 40m Fast-Paced Walk Test (40m-FPWT)	Measured at baseline, 16-week, and 12-month follow-up.	The 40m-FPWT is a physical function test designed to measure the ability to walk quickly over short distances and is measured as the time it takes to complete a 40 m course at a fast walking pace.
Change in the HOOS quality-of-life subscale	Measured at baseline, 16-week, and 12-month follow-up.	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.
Change in the HOOS sports and recreation subscale	Measured at baseline, 16-week, and 12-month follow-up.	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.
Change in leg extension muscle power (watt/kg body weight)	Measured at baseline, 16-week, and 12-month follow-up.	The Nottingham Power Rig (NPR) is used to measure leg extensor muscle power. The NPR measures the power output in total watt and watt pr. bodyweight in kilograms from a seated push on a flat pedal which is transmitted by a lever and chain to spin a flywheel. The NPR is a safe and reliable method to measure explosive knee extensor muscle power and has been validated as a clinically important measure of muscle function in elderly individuals.
Global Perceived Effect (GPE)	Measured at 16-week and 12-month follow-up.	The GPE will be used as a measure of patient-rated recovery and will be assessed for three domains; pain, activities of daily living, and quality of life rated on a 7-point Likert scale ranging from 'very bad' (worst) to 'very good' (best)
AE (Adverse Events) & Serious Adverse Events (SAE)	Registered throughout the 12-month study period.	Continuous registration of health issues and injuries. The events will be monitored by the physiotherapists supervising the exercise sessions. Further, patients will be asked at 4- and 12-month follow-ups about potential AE and SAE using open-probe questions.
Drop-outs	Registered throughout the 12-month study period.	Number of drop-out from the interventions.
Adherence to the 16-week intervention	Registered throughout the 16-week initial intervention.	High adherence is defined as attendance in ≥75% of the exercise sessions.

Trial Locations

Locations (9)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Aarhus University; 🇩🇰 Aarhus, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

University Hospital, Gentofte, Copenhagen; 🇩🇰 Hellerup, Denmark

Gødstrup Hospital; 🇩🇰 Herning, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Regional Hospital Silkeborg; 🇩🇰 Silkeborg, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark

Regional Hospital Viborg; 🇩🇰 Viborg, Denmark