Trials / Active Not Recruiting
Active Not RecruitingNCT05657054
Exercise Intervention Targeting Hip Strengthening Compared to Usual Care in Patients Undergoing Revision Hip Replacement
Effect of an Exercise Intervention Targeting Hip Strengthening in Patients Undergoing Revision Total Hip Replacement - a Multicenter, Randomized Controlled Trial (The Strong Hip Trial)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- Sponsor
- University of Aarhus · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| OTHER | 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. |
Timeline
- Start date
- 2022-11-25
- Primary completion
- 2024-12-03
- Completion
- 2027-12-01
- First posted
- 2022-12-20
- Last updated
- 2026-01-26
Locations
9 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05657054. Inclusion in this directory is not an endorsement.