Exercise Intervention Targeting Hip Strengthening Compared to Usual Care in Patients Undergoing Revision Hip Replacement
NCT ID: NCT05657054
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
84 participants
INTERVENTIONAL
2022-11-25
2027-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Strength group
Group 1
Exercise Intervention Targeting Hip Strengthening
An initial 16-week exercise intervention of 45 minutes of training 3 times a week in the patient's own home or at a rehabilitation center. Patients will be instructed by a physiotherapist during the first 3 sessions, in order to be able to perform the exercises at home. Subsequently, there are physiotherapist-supervised sessions once every second week. The delivery of the supervised sessions is based on the patient's preferences, either by physical attendance or remotely in the patient's home. The intervention will consist of 4 exercises adapted from the NEMEX program targeting lower extremity muscle strength, stability, postural function, and postural orientation. Progression is made when an exercise is performed with good sensorimotor control and good performance quality and with minimal exertion and adequate movement control. Progression is primarily provided by 3 levels of difficulty and secondly by varying the number of repetitions or where possible, by increasing the weight load.
Control group
Group 2
Usual Care
The intervention will consist of a rehabilitation intervention corresponding to standard care in the participating municipalities (i.e. content and duration of intervention). The intervention will be delivered individually or as group training, based on a clinical assessment of the individual patients' needs. The intervention can be supported by home-based exercises following instruction from a physiotherapist, supplemented by the provision of written information or access to a virtual training program. The intervention occurs in either the rehabilitation center's gym or the patient's home. The training sessions may consist of some of the following parameters: Strength training, stretching, functional training e.g. walking and stair climbing, stability training, balance training, endurance training, and gait correction.
Interventions
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Exercise Intervention Targeting Hip Strengthening
An initial 16-week exercise intervention of 45 minutes of training 3 times a week in the patient's own home or at a rehabilitation center. Patients will be instructed by a physiotherapist during the first 3 sessions, in order to be able to perform the exercises at home. Subsequently, there are physiotherapist-supervised sessions once every second week. The delivery of the supervised sessions is based on the patient's preferences, either by physical attendance or remotely in the patient's home. The intervention will consist of 4 exercises adapted from the NEMEX program targeting lower extremity muscle strength, stability, postural function, and postural orientation. Progression is made when an exercise is performed with good sensorimotor control and good performance quality and with minimal exertion and adequate movement control. Progression is primarily provided by 3 levels of difficulty and secondly by varying the number of repetitions or where possible, by increasing the weight load.
Usual Care
The intervention will consist of a rehabilitation intervention corresponding to standard care in the participating municipalities (i.e. content and duration of intervention). The intervention will be delivered individually or as group training, based on a clinical assessment of the individual patients' needs. The intervention can be supported by home-based exercises following instruction from a physiotherapist, supplemented by the provision of written information or access to a virtual training program. The intervention occurs in either the rehabilitation center's gym or the patient's home. The training sessions may consist of some of the following parameters: Strength training, stretching, functional training e.g. walking and stair climbing, stability training, balance training, endurance training, and gait correction.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Vejle Hospital
OTHER
Regionshospitalet Silkeborg
OTHER
Gødstrup Hospital
OTHER
Viborg Regional Hospital
OTHER
Odense University Hospital
OTHER
Bispebjerg Hospital
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Martin B Stisen, MSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital and Aarhus University
Inger Mechlenburg, Prof.
Role: STUDY_DIRECTOR
Aarhus University Hospital and Aarhus University
Alma B Pedersen, Prof.
Role: STUDY_DIRECTOR
Aarhus University Hospital and Aarhus University
Troels Kjeldsen, MSc
Role: STUDY_DIRECTOR
Aarhus University Hospital and Aarhus University
Locations
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Aarhus University
Aarhus, , Denmark
Aarhus University Hospital
Aarhus N, , 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
Countries
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References
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Stisen MB, Pedersen AB, Kjeldsen T, Mechlenburg I. Effect of an exercise intervention targeting hip strengthening in patients undergoing revision total hip replacement-A study protocol for a multicenter randomized controlled trial. Physiother Res Int. 2024 Jul;29(3):e2101. doi: 10.1002/pri.2101.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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StrongHip
Identifier Type: -
Identifier Source: org_study_id