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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05927935
Registration number
NCT05927935
Ethics application status
Date submitted
31/05/2023
Date registered
3/07/2023
Date last updated
19/04/2024
Titles & IDs
Public title
First-line Treatment for Femoroacetabular Impingement Syndrome
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Scientific 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)
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Secondary ID [1]
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BetterHip
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Universal Trial Number (UTN)
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Trial acronym
BetterHip
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Femoroacetabular Impingement Syndrome
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Supervised strength exercise intervention
Other interventions - Minimal educational intervention (usual care)
Experimental: Supervised strength exercise intervention - Group 1
Active Comparator: Usual care - Group 2
Other interventions: Supervised strength exercise intervention
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.
Other interventions: Minimal educational intervention (usual care)
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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention.
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Assessment method [1]
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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.
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Timepoint [1]
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Measured at baseline, 3, 6 and 12 months.
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Secondary outcome [1]
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Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention.
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Assessment method [1]
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Maximal lower extremity strength is measured by a 1 RM test in a leg press resistance training machine.
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Timepoint [1]
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Measured at baseline and 6 months.
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Secondary outcome [2]
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Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention.
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Assessment method [2]
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The One-Leg Rise Test is a reliable global measure of lower limb strength and endurance.
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Timepoint [2]
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Measured at baseline and 6 months.
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Secondary outcome [3]
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Change in functional performance measured by the Single leg hop for distance test at end of intervention.
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Assessment method [3]
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The single-leg hop for distance test is a reliable functional performance test evaluating power generation and absorption.
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Timepoint [3]
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Measured at baseline and 6 months.
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Secondary outcome [4]
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Exercise level
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Assessment method [4]
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Exercise level (1-3), higher level indicating higher level of difficulty in exercises.
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Timepoint [4]
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Registered throughout the 6 month intervention in the supervised strength exercise intervention.
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Secondary outcome [5]
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Number of sets
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Assessment method [5]
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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.
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Timepoint [5]
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Registered throughout the 6 month intervention in the supervised strength exercise intervention.
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Secondary outcome [6]
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Number of repetitions
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Assessment method [6]
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Number of repetitions, higher indication completion of more repetitions in each exercise session. Number of repetitions will be used to calculate exercise dosage.
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Timepoint [6]
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Registered throughout the 6 month intervention in the supervised strength exercise intervention.
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Secondary outcome [7]
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External load
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Assessment method [7]
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External load will be used to calculate exercise dosage.
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Timepoint [7]
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Registered throughout the 6 month intervention in the supervised strength exercise intervention.
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Secondary outcome [8]
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Rate of perceived exertion
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Assessment method [8]
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Rate of perceived exertion (0-10), higher scores indicating larger perceived effort.
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Timepoint [8]
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Registered throughout the 6 month intervention in the supervised strength exercise intervention.
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Secondary outcome [9]
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The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS)
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Assessment method [9]
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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).
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Timepoint [9]
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Measured at baseline, 6 and 12 months.
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Secondary outcome [10]
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Global Perceived Effect (GPE)
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Assessment method [10]
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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)
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Timepoint [10]
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Measured at 6 and 12 months.
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Secondary outcome [11]
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Hip surgery
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Assessment method [11]
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Number of hip surgeries within the follow-up period.
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Timepoint [11]
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Measured at baseline, 3, 6 and 12 months.
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Secondary outcome [12]
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AE (Adverse Events) & Serious Adverse Events (SAE)
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Assessment method [12]
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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.
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Timepoint [12]
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Registered throughout the 12-month study period.
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Secondary outcome [13]
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Drop-outs
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Assessment method [13]
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Number of drop-out from the intervention groups.
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Timepoint [13]
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Registered throughout the 12-month study period.
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Eligibility
Key inclusion criteria
1. Activity- or position-related pain lasting = 3 months
2. Positive Flexion-Adduction-Internal rotation (FADIR) test
3. Cam-type FAIS; x-ray alpha angle => 60 degrees
4. Pincer-type FAIS; lateral center edge angle > 39 degrees or crossover-sign
5. Mixed-type FAIS; a combination of cam- and pincer-type impingement
6. Motivated to exercise 2 times a week for 6 months
7. 18-50 years old
8. Body Mass Index (BMI) score < 35
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Minimum age
18
Years
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Maximum age
50
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Physiotherapist-led strengthening exercises targeting the hip for at least 3 months
for = 6 sessions prior to inclusion
2. Previous hip surgery or other major hip injury in index hip (i.e., hip arthroscopy,
fracture, calves perthes, necrosis or luxation).
3. Evidence of pre-existing osteoarthritis, defined as Tönnis grade = 2 or
Kellgreen-Lawrence = 2
4. Evidence of pre-existing osteoarthritis, defined as lateral joint space width = 3 mm
(measured at the lateral sourcil).
5. Hip dysplasia, defined as a Center-Edge-angle (CE-angle) = 25° and an acetabular index
> 10°
6. Comorbidities or other problems considered to affect hip function and participation in
exercise
7. Unable to communicate in the respective languages of the participating countries
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2027
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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La Trobe University - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Region Of Southern Denmark
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Country [2]
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Denmark
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State/province [2]
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Aalborg
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Country [3]
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Denmark
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State/province [3]
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Aarhus
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Country [4]
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Denmark
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State/province [4]
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Horsens
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Country [5]
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Denmark
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State/province [5]
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Hvidovre
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Aarhus
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Horsens Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Aalborg University Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Aarhus University Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Odense University Hospital
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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La Trobe University
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Hvidovre University Hospital
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Address [6]
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Country [6]
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Ethics approval
Ethics application status
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Summary
Brief 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 intervention to usual first-line care in
patients with FAIS.
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05927935
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Frederik Foldager, MSc
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Address
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Aarhus University Hospital and Aarhus University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Frederik Foldager, MSc
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Address
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Country
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Phone
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+4522782041
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05927935
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