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Femoroacetabular Impingement SyndromeBetterHipNCT05927935

First-line Treatment for Femoroacetabular Impingement Syndrome

A study testing Supervised strength exercise intervention in people with Femoroacetabular Impingement Syndrome, run by University of Aarhus at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness. The goal of this randomized controlled trial is to compare the clinical effectiveness and cost-effectiveness of a supervised strength exercise… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Femoroacetabular Impingement Syndrome
What is being tested?
Supervised strength exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesin 2 countries
Study dates
1 Jul 2023to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Activity- or position-related pain lasting ≥ 3 months
  • Positive Flexion-Adduction-Internal rotation (FADIR) test
  • Cam-type FAIS; x-ray alpha angle => 60 degrees
  • Pincer-type FAIS; lateral center edge angle > 39 degrees or crossover-sign
  • Mixed-type FAIS; a combination of cam- and pincer-type impingement
  • Motivated to exercise 2 times a week for 6 months
  • 18-50 years old
  • Body Mass Index (BMI) score < 35

Who cannot join

  • Physiotherapist-led strengthening exercises targeting the hip for at least 3 months for ≥ 6 sessions prior to inclusion
  • Previous hip surgery or other major hip injury in index hip (i.e., hip arthroscopy, fracture, calves perthes, necrosis or luxation).
  • Evidence of pre-existing osteoarthritis, defined as Tönnis grade ≥ 2 or Kellgreen-Lawrence ≥ 2
  • Evidence of pre-existing osteoarthritis, defined as lateral joint space width ≥ 3 mm (measured at the lateral sourcil).
  • Hip dysplasia, defined as a Center-Edge-angle (CE-angle) ≤ 25° and an acetabular index > 10°
  • Comorbidities or other problems considered to affect hip function and participation in exercise
  • Unable to communicate in the respective languages of the participating countries

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Denmark4 sites
  • Orthopaedic Center, Alborg sygehus, Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8000

  • Horsens Regional Hospital

    Horsens, 8700

  • Hvidovre Hospital

    Hvidovre, 2650

Other trials in Denmark

Australia1 site
  • La Trobe University

    Melbourne

Other trials in Australia

About this study

Official title: First-line Treatment for Femoroacetabular Impingement Syndrome: a Multicenter Randomized Controlled Trial Comparing a Supervised Strength Exercise Intervention to Usual Care on Hip-related Quality of Life. (Better Hip Trial)

There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness.

The goal of this randomized controlled trial is to compare the clinical effectiveness and cost-effectiveness of a supervised strength exercise intervention to usual first-line care in patients with FAIS.

Read more

The main hypothesis it aims to investigate are:

  1. 6-months of supervised strength exercise intervention is superior (i.e., at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention.
  2. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS.
  3. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS.
Read the detailed description

There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness.

The Better Hip trial is a multicenter, stratified (by hospital site), randomized (allocation 1:1), controlled, assessor blinded, superiority trial conducted in Denmark (Aarhus, Horsens, Aalborg, and Odense) and Australia (Melbourne). Eligible patients will either be randomized to a supervised strength exercise intervention or to usual care. The primary outcome will be hip-related quality of life measured at end of intervention (6 months) with the iHOT-33. A health economic evaluation will assess the difference in cost-effectiveness between groups from baseline to 12 months. Secondary outcomes will be measured at baseline, 3-, 6- and 12- months after initiating the intervention for patient reported outcome measures (PROMs), and at baseline and 6-months for objective outcome measures obtained at clinical assessments.

This trial aims to investigate the clinical and cost-effectiveness of a supervised strength exercise intervention compared to usual care as first-line treatment in patients with FAIS. A secondary aim is to explore how exercise adherence and dosage of a supervised strength exercise intervention mediates outcomes.

The investigators hypothesis that;

  1. 6-months of supervised strength exercise intervention is superior (i.e., at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention.
  2. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS.
  3. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS.

A full trial protocol will be published and made publicly available prior to analysis for the primary paper. All primary and secondary outcomes will be analysed with the intention-to-treat principle. Supplementary to the intention-to-treat analysis a per protocol analysis will be conducted. Between-group differences will be analyzed using a linear mixed effect model for continuous outcomes and a logistical mixed effect model for binary outcome variables. Intervention group, recruitment site and time will be included as fixed effects and patients will be included as a random effect. Incremental cost-effectiveness ratios (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years for cost-utility and iHOT-33 for cost-effectiveness)

Being tested
Supervised strength exercise intervention, Minimal educational intervention (usual care)
Keywords
Femoroacetabular Impingement Syndrome, FAI, Hip, Usual care, Exercise Therapy, Health economic evaluation, Effectiveness
Medical subject headings
Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised strength exercise interventionOther

    A 6 months exercise intervention of training 2 times a week. Patients will be instructed by a physiotherapist during the first session, in order to be able to perform the exercises at home or in a local gymnasium based on personal preference. Subsequently, there are supervised sessions once every second week (12 sessions in total). The intervention will consist of 6 exercises. 4 targeting planes of hip movement (i.e., flexion, extension, abduction and adduction), a general lower extremity- and a trunk exercise. Progression is made when an exercise is performed with the designated number of sets and repetitions, with good performance quality and tolerable pain. Progression is provided by 3 levels of difficulty and secondly by the number of repetitions or where possible by increasing the external load. In addition, patient information and education is identical to what is delivered in the usual care group.

  • Minimal educational intervention (usual care)Other

    Usual care varies slightly across regions in Denmark and between Denmark and Australia. The consensus is that the patient should be advised to remain physically active and reduce symptom provoking activities. Therefore, patients will receive a referral for physiotherapy and supplementary a minimal educational intervention is provided as usual care. Patients allocated to the usual care group will receive written information on self-management of hip symptoms including advice about staying physically active in accordance with the World Health Organization guidelines on physical activity and sedentary behavior. Moreover, self-management of hip symptoms will include advice to reduce symptoms by focusing on symptom-lowering activities and sports. The content of the information provided as usual care will be identical to the information provided to the patients in the intervention group. Patients in the usual care group can continue to seek any additional treatment they would like.

Study groups in NCT05927935
Study groupRoleWhat they receive
Supervised strength exercise interventionExperimentalGroup 1
Receives: Other: Supervised strength exercise intervention
Usual careActive comparatorGroup 2
Receives: Other: Minimal educational intervention (usual care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention.

    The iHOT-33 is a 33-item self-administered valid and reliable outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The total score ranges from 0 to 100, with higher scores indicating better hip-related quality of life.

    Measured: Measured at baseline, 3, 6 and 12 months.

Secondary outcomes (13)
  1. Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention.

    Maximal lower extremity strength is measured by a 1 RM test in a leg press resistance training machine.

    Measured: Measured at baseline and 6 months.

  2. Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention.

    The One-Leg Rise Test is a reliable global measure of lower limb strength and endurance.

    Measured: Measured at baseline and 6 months.

  3. Change in functional performance measured by the Single leg hop for distance test at end of intervention.

    The single-leg hop for distance test is a reliable functional performance test evaluating power generation and absorption.

    Measured: Measured at baseline and 6 months.

  4. Exercise level

    Exercise level (1-3), higher level indicating higher level of difficulty in exercises.

    Measured: Registered throughout the 6 month intervention in the supervised strength exercise intervention.

  5. Number of sets

    Number of sets (0-3), higher indicating completion of more sets in each exercise sessions. Number of sets will be used to calculate exercise dosage.

    Measured: Registered throughout the 6 month intervention in the supervised strength exercise intervention.

  6. Number of repetitions

    Number of repetitions, higher indication completion of more repetitions in each exercise session. Number of repetitions will be used to calculate exercise dosage.

    Measured: Registered throughout the 6 month intervention in the supervised strength exercise intervention.

  7. External load

    External load will be used to calculate exercise dosage.

    Measured: Registered throughout the 6 month intervention in the supervised strength exercise intervention.

  8. Rate of perceived exertion

    Rate of perceived exertion (0-10), higher scores indicating larger perceived effort.

    Measured: Registered throughout the 6 month intervention in the supervised strength exercise intervention.

  9. The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS)

    Patient Acceptable Symptom State (PASS), defined as the value beyond which patients consider themselves well is evaluated using a single question. The scale is binary (yes/no).

    Measured: Measured at baseline, 6 and 12 months.

  10. Global Perceived Effect (GPE)

    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 'Worse, an important worsening' (worst) to 'Better, an important improvement' (best)

    Measured: Measured at 6 and 12 months.

  11. Hip surgery

    Number of hip surgeries within the follow-up period.

    Measured: Measured at baseline, 3, 6 and 12 months.

  12. AE (Adverse Events) & Serious Adverse Events (SAE)

    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 6- and 12-month follow-ups about potential AE and SAE using open-probe questions.

    Measured: Registered throughout the 12-month study period.

  13. Drop-outs

    Number of drop-out from the intervention groups.

    Measured: Registered throughout the 12-month study period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start1 Jul 2023
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927935
Sponsor's protocol ID
BetterHip
Acronym
BetterHip
Status last verified
May 2025
First submitted
31 May 2023
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: What data in particular will be shared: All of the individual participant data collected during the trial, after deidentification. What other documents will be available: Study Protocol, Statistical Analysis Plan, Informed Consent Form, Data Dictionary and Analytic Code. For what types of analyses: For individual participant data meta-analysis and systematic review and meta-analysis.

Publications

  • Foldager FN, Kierkegaard-Brochner S, Kemp JL, van Tulder MW, Lund B, Mygind-Klavsen B, Bibby BM, Dalgas U, Mechlenburg I. First-line treatment for femoroacetabular impingement syndrome and hip-related quality of life: study protocol for a multicentre randomised controlled trial comparing a 6-month supervised strength exercise intervention to usual care (the Better Hip Trial). BMJ Open. 2024 Jun 21;14(6):e078726. doi: 10.1136/bmjopen-2023-078726.

    PubMed 38908842

Questions about this trial

What is this clinical trial studying?

A study testing Supervised strength exercise intervention in people with Femoroacetabular Impingement Syndrome, run by University of Aarhus at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention. (time frame: Measured at baseline, 3, 6 and 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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