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

NCT05657054 | Active Not Recruiting DMC

• 1 other identifier: StrongHip
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 9

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.

Conditions

Revision Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Change in functional performance measured by the 30-seconds chair stand test

  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.

  Measured at baseline, 16-week, and 12-month follow-up.

Secondary Outcomes (12)

• Change in the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale

  Measured at baseline, 16-week, and 12-month follow-up.

• Change in the HOOS symptoms subscale

  Measured at baseline, 16-week, and 12-month follow-up.

• Change in the HOOS activities of daily living (ADL) function subscale

  Measured at baseline, 16-week, and 12-month follow-up.

• Change in the HOOS quality-of-life subscale

  Measured at baseline, 16-week, and 12-month follow-up.

• Change in the HOOS sports and recreation subscale

  Measured at baseline, 16-week, and 12-month follow-up.

Other Outcomes (3)

• Physical activity

  Measured at 12-week and 12-month follow-up.

• Change in pain measured on a Numerical Rating Scale (NRS)

  Measured at baseline, 16-week, and 12-month follow-up.

• Change in EuroQol Group 5-Dimension 5-Level (EQ-5D-5L)

  Measured at baseline, 16-week, and 12-month follow-up.

Study Arms (2)

Strength group

EXPERIMENTAL

Group 1

Other: Exercise Intervention Targeting Hip Strengthening

Control group

ACTIVE COMPARATOR

Group 2

Other: Usual Care

Interventions

Exercise Intervention Targeting Hip Strengthening OTHER

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.

Strength group

Usual Care OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Regionshospitalet Silkeborg: collaborator
• Gødstrup Hospital: collaborator
• Viborg Regional Hospital: collaborator
• Bispebjerg Hospital: collaborator
• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Vejle Hospital: collaborator
• Odense University Hospital: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (9)

Aarhus University

Aarhus, 8000, Denmark

Location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

University Hospital, Gentofte, Copenhagen

Hellerup, 2900, Denmark

Location

Gødstrup Hospital

Herning, 7400, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Regional Hospital Silkeborg

Silkeborg, 9640, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Regional Hospital Viborg

Viborg, 8800, Denmark

Location

Related Publications (2)

• Stisen MG, Pedersen AB, Kjeldsen T, Foldager FN, Lamm M, Assenholt A, Hvidberg KL, Rasmussen MK, Aalund PK, Frandsen CF, Holsgaard-Larsen A, Haubro MH, Bieler T, Overgaard S, Beck T, Ingwersen KG, Parner ET, Mechlenburg I. Hip strengthening exercise compared to standard rehabilitation after revision hip replacement: a multicenter randomized controlled trial. Ann Phys Rehabil Med. 2026 Jan 13;69(4):102076. doi: 10.1016/j.rehab.2025.102076. Online ahead of print.

  PMID: 41534141 DERIVED

• 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.

  PMID: 38859640 DERIVED

Study Officials

• Martin B Stisen, MSc

  Aarhus University Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, Prof.

  Aarhus University Hospital and Aarhus University

  STUDY DIRECTOR

• Alma B Pedersen, Prof.

  Aarhus University Hospital and Aarhus University

  STUDY DIRECTOR

• Troels Kjeldsen, MSc

  Aarhus University Hospital and Aarhus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 20, 2022
• Study Start: November 25, 2022
• Primary Completion: December 3, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after publication of the trial.
• Access Criteria: Data access will be reviewed by the author group. Requesters will be required to sign a Data Access Agreement.

Locations

DK (9)