Femoroacetabular ImpingementNCT05031390
the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
A study testing Physiotherapist-led training in people with Femoroacetabular Impingement, run by Horsens Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Physiotherapist-led training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 1 Dec 2022
- 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
- Patients aged 18-50 years old
- Diagnosed with FAIS according to the Warwick agreement
- Patients having cam morphology should have an alpha angle of > 55 degrees on an anterior-posterior radiograph.
- Patients having pincer should have a lateral centre edge angle of >39 degrees on an anterior-posterior radiograph.
- Lateral joint space width should be >3 mm.
- Body mass index is below 30.
- Motivated for participation in a 12 week training program with 8 physical attendances.
Who cannot join
- Received physiotherapist-led treatment in the past 3 months,
- Previous hip surgery in included hip or other major hip injury,
- Systemic conditions e.g. rheumatoid arthritis, cancer,
- Chronical pain syndromes,
- Unable to perform testing procedures,
- Unable to attend a 12-week treatment program or baseline and follow-up assessments
- Contraindications to radiographs (e.g. pregnancy)
- Unable to read or understand questionnaires and/or instructions
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).
Read the detailed description
The aim of this study is to investigate the feasibility of a 12-weeks (progressive) exercise program in patients with FAIS. Feasibility is evaluated on the recruitment strategy, patient adherence to the exercises and their experiences with and motivation for performing exercises. Furthermore, the investigators wish to investigate the variation of data before and after the exercise program to help estimate a suitable sample size for a future randomized controlled trial.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Physiotherapist-led training
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-led trainingProcedure or surgery
Patients will undergo a 12-week physiotherapist-led training program consisting of 8 supervised sessions and home-based training in between
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapist-led training | Experimental | Physiotherapy-led training of patients with FAIS Receives: Procedure: Physiotherapist-led training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed exercise sessions
Number of completed exercise sessions. A high adherence is defined as attendance of > 75% of planned sessions
Measured: 0-12 weeks
Completion of training program
The training program is considered completed if patients are not dropping out of the study before the end of the 12 weeks. Completion rate will be calculated as % patients who completed the study
Measured: 0-12 weeks
Secondary outcomes (7)
The Copenhagen Hip and Groin Outcome Score (HAGOS)
HAGOS is a questionnaire developed for young, active persons experiencing hip and/or groin pain. It consists of 6 subscales: Pain, Symptoms, Activities of Daily Living, Sport, Participation in Sport and Hip-related quality of life. The main subscales used in this study are HAGOS pain and sport.
Measured: Change from 0-12 weeks
The International Hip Outcome Tool (iHOT-33)
iHOT-33 is a questionnaire focussing at patients' hip related quality of life in 33 questions. Both a total score and sub scales: "Symptoms and functional limitations", "Sports and recreational activities", "Job related concerns" and "Social, emotional and lifestyle concerns", are extracted from the questionnaire.
Measured: Change from 0-12 weeks
The Hip Sports Activity Scale (HSAS)
Current physical activity measured from 0 to 8 points, 0 being no activity and 8 being an athlete
Measured: Change from 0-12 weeks
Maximal hip muscle strength
Change (Nm/kg) in maximal hip flexion, extension, abduction and adduction from 0-12 weeks
Measured: Change from 0-12 weeks
One-legged hop for distance
Change (cm) i hop distance from 0-12 weeks
Measured: 0-12 weeks
Y-balance board
Change (cm) in ability to perform on the y balance board from 0-12 weeks
Measured: 0-12 weeks
Patient Acceptable Symptom State
Patient Acceptable Symptom State (yes/no): Change in number of patients reporting yes vs. no from baseline to 12 weeks
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, La Trobe University
- Responsible party
- Principal investigator, Jeppe Lange, Horsens Hospital
- Investigators
- Signe Kierkegaard, PhD, Principal investigator, Regionshospitalet Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031390
- Sponsor's protocol ID
- 1-16-02-724-18
- Status last verified
- Jul 2025
- First submitted
- 12 Aug 2021
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot study with few participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
- ClinicalTrials.gov ID
- NCT05031390
- Acronym / sponsor ID
- 1-16-02-724-18
- Conditions
- Femoroacetabular Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, La Trobe University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).
Detailed description
The aim of this study is to investigate the feasibility of a 12-weeks (progressive) exercise program in patients with FAIS. Feasibility is evaluated on the recruitment strategy, patient adherence to the exercises and their experiences with and motivation for performing exercises. Furthermore, the investigators wish to investigate the variation of data before and after the exercise program to help estimate a suitable sample size for a future randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist-led training | Experimental | Procedure: Physiotherapist-led trainingPhysiotherapy-led training of patients with FAIS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged 18-50 years old
- Diagnosed with FAIS according to the Warwick agreement
- Patients having cam morphology should have an alpha angle of > 55 degrees on an anterior-posterior radiograph.
- Patients having pincer should have a lateral centre edge angle of >39 degrees on an anterior-posterior radiograph.
- Lateral joint space width should be >3 mm.
Key exclusion criteria (8 listed)
- Received physiotherapist-led treatment in the past 3 months,
- Previous hip surgery in included hip or other major hip injury,
- Systemic conditions e.g. rheumatoid arthritis, cancer,
- Chronical pain syndromes,
- Unable to perform testing procedures,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist-led trainingPatients will undergo a 12-week physiotherapist-led training program consisting of 8 supervised sessions and home-based training in between | Procedure or surgery | Physiotherapist-led training |
Primary outcome
Number of completed exercise sessions
Time frame: 0-12 weeks
Number of completed exercise sessions. A high adherence is defined as attendance of > 75% of planned sessions
Completion of training program
Time frame: 0-12 weeks
The training program is considered completed if patients are not dropping out of the study before the end of the 12 weeks. Completion rate will be calculated as % patients who completed the study
7 secondary outcomes
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Time frame: Change from 0-12 weeks
The International Hip Outcome Tool (iHOT-33)
Time frame: Change from 0-12 weeks
The Hip Sports Activity Scale (HSAS)
Time frame: Change from 0-12 weeks
Maximal hip muscle strength
Time frame: Change from 0-12 weeks
One-legged hop for distance
Time frame: 0-12 weeks
Y-balance board
Time frame: 0-12 weeks
Patient Acceptable Symptom State
Time frame: 0-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Pilot study with few participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Signe Kierkegaard, PhD principal investigator
Regionshospitalet Horsens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-led training in people with Femoroacetabular Impingement, run by Horsens Hospital at 1 site in Denmark.
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 7 inclusion and 8 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Number of completed exercise sessions (time frame: 0-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.