Clinical trial NCT05657054: Exercise Intervention Targeting Hip Strengthening Compared to Usual Care in Patients Undergoing Revision Hip Replacement
Official title: Effect of an Exercise Intervention Targeting Hip Strengthening in Patients Undergoing Revision Total Hip Replacement - a Multicenter, Randomized Controlled Trial (The Strong Hip Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Revision Total Hip Arthroplasty
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Vejle Hospital
name: Regionshospitalet Silkeborg
name: Gødstrup Hospital
name: Viborg Regional Hospital
name: Odense University Hospital
name: Bispebjerg Hospital
name: University Hospital, Gentofte, Copenhagen
First posted: 2022-12-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in functional performance measured by the 30-seconds chair stand test
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
Secondary outcomes:
measure: Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Change in the HOOS symptoms subscale
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Change in the HOOS activities of daily living (ADL) function subscale
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Change in the HOOS quality-of-life subscale
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Change in the HOOS sports and recreation subscale
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Change in 40m Fast-Paced Walk Test (40m-FPWT)
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Change in 9-step Timed Stair Climb Test (9-step TSCT)
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Change in leg extension muscle power (watt/kg body weight)
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Global Perceived Effect (GPE)
timeFrame: Measured at 16-week and 12-month follow-up.
measure: AE (Adverse Events) & Serious Adverse Events (SAE)
timeFrame: Registered throughout the 12-month study period.
measure: Adherence to the 16-week intervention
timeFrame: Registered throughout the 16-week initial intervention.
measure: Drop-outs
timeFrame: Registered throughout the 12-month study period.
Other outcomes:
measure: Physical activity
timeFrame: Measured at 12-week and 12-month follow-up.
measure: Change in pain measured on a Numerical Rating Scale (NRS)
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
measure: Change in EuroQol Group 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Measured at baseline, 16-week, and 12-month follow-up.
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Hellerup
country: Denmark
facility: University Hospital, Gentofte, Copenhagen
city: Herning
country: Denmark
facility: Gødstrup Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Silkeborg
country: Denmark
facility: Regional Hospital Silkeborg
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Viborg
country: Denmark
facility: Regional Hospital Viborg
Study officials:
affiliation: Aarhus University Hospital and Aarhus University
name: Martin B Stisen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital and Aarhus University
name: Inger Mechlenburg, Prof.
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital and Aarhus University
name: Alma B Pedersen, Prof.
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital and Aarhus University
name: Troels Kjeldsen, MSc
role: STUDY_DIRECTOR
References: