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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05927935




Registration number
NCT05927935
Ethics application status
Date submitted
31/05/2023
Date registered
3/07/2023

Titles & IDs
Public title
First-line Treatment for Femoroacetabular Impingement Syndrome
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)
Secondary ID [1] 0 0
BetterHip
Universal Trial Number (UTN)
Trial acronym
BetterHip
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femoroacetabular Impingement Syndrome 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention.
Timepoint [1] 0 0
Measured at baseline, 3, 6 and 12 months.
Secondary outcome [1] 0 0
Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention.
Timepoint [1] 0 0
Measured at baseline and 6 months.
Secondary outcome [2] 0 0
Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention.
Timepoint [2] 0 0
Measured at baseline and 6 months.
Secondary outcome [3] 0 0
Change in functional performance measured by the Single leg hop for distance test at end of intervention.
Timepoint [3] 0 0
Measured at baseline and 6 months.
Secondary outcome [4] 0 0
Exercise level
Timepoint [4] 0 0
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Secondary outcome [5] 0 0
Number of sets
Timepoint [5] 0 0
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Secondary outcome [6] 0 0
Number of repetitions
Timepoint [6] 0 0
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Secondary outcome [7] 0 0
External load
Timepoint [7] 0 0
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Secondary outcome [8] 0 0
Rate of perceived exertion
Timepoint [8] 0 0
Registered throughout the 6 month intervention in the supervised strength exercise intervention.
Secondary outcome [9] 0 0
The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS)
Timepoint [9] 0 0
Measured at baseline, 6 and 12 months.
Secondary outcome [10] 0 0
Global Perceived Effect (GPE)
Timepoint [10] 0 0
Measured at 6 and 12 months.
Secondary outcome [11] 0 0
Hip surgery
Timepoint [11] 0 0
Measured at baseline, 3, 6 and 12 months.
Secondary outcome [12] 0 0
AE (Adverse Events) & Serious Adverse Events (SAE)
Timepoint [12] 0 0
Registered throughout the 12-month study period.
Secondary outcome [13] 0 0
Drop-outs
Timepoint [13] 0 0
Registered throughout the 12-month study period.

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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
La Trobe University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Region Of Southern Denmark
Country [2] 0 0
Denmark
State/province [2] 0 0
Aalborg
Country [3] 0 0
Denmark
State/province [3] 0 0
Aarhus
Country [4] 0 0
Denmark
State/province [4] 0 0
Horsens
Country [5] 0 0
Denmark
State/province [5] 0 0
Hvidovre

Funding & Sponsors
Primary sponsor type
Other
Name
University of Aarhus
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Horsens Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Aalborg University Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Aarhus University Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Odense University Hospital
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
La Trobe University
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Hvidovre University Hospital
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frederik Foldager, MSc
Address 0 0
Aarhus University Hospital and Aarhus University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Frederik Foldager, MSc
Address 0 0
Country 0 0
Phone 0 0
4522782041
Fax 0 0
Email 0 0
frederikfoldager@clin.au.dk
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
When will data be available: Immediately following publication. The data set will be kept for at least 5 years after the last publication of new results in Denmark and 7 years in Australia as per standards in accordance with the Responsible Research Practice at Aarhus University in Denmark and Ethical Standards at Human Research Ethics Committee at Latrobe University in Australia.
Available to whom?
Researchers who provide a methodologically sound proposal. Data access will be reviewed by the author group.

By what mechanism will data be made available: The data will be available via the Aarhus University Institutional Data Access to researchers who meet the criteria for access to confidential data. Restrictions may apply according to EU data transfer legislation.

Proposals should be directed to Inger.mechlenburg@clin.au.dk and Frederikfoldager@clin.au.dk. To gain access, data requestors will need to sign a data access agreement.

Requesters will be required to sign a Data Access Agreement.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05927935