- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05031390
the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
July 30, 2025 updated by: Jeppe Lange, Horsens Hospital
The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Danmark
-
Horsens, Danmark, Denmark, DK-8700
- Signe Kierkegaard
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physiotherapist-led training
Physiotherapy-led training of patients with FAIS
|
Patients will undergo a 12-week physiotherapist-led training program consisting of 8 supervised sessions and home-based training in between
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
0-12 weeks
|
|
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
|
0-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Time Frame: Change from 0-12 weeks
|
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.
|
Change from 0-12 weeks
|
|
The International Hip Outcome Tool (iHOT-33)
Time Frame: Change from 0-12 weeks
|
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.
|
Change from 0-12 weeks
|
|
The Hip Sports Activity Scale (HSAS)
Time Frame: Change from 0-12 weeks
|
Current physical activity measured from 0 to 8 points, 0 being no activity and 8 being an athlete
|
Change from 0-12 weeks
|
|
Maximal hip muscle strength
Time Frame: Change from 0-12 weeks
|
Change (Nm/kg) in maximal hip flexion, extension, abduction and adduction from 0-12 weeks
|
Change from 0-12 weeks
|
|
One-legged hop for distance
Time Frame: 0-12 weeks
|
Change (cm) i hop distance from 0-12 weeks
|
0-12 weeks
|
|
Y-balance board
Time Frame: 0-12 weeks
|
Change (cm) in ability to perform on the y balance board from 0-12 weeks
|
0-12 weeks
|
|
Patient Acceptable Symptom State
Time Frame: 0-12 weeks
|
Patient Acceptable Symptom State (yes/no): Change in number of patients reporting yes vs. no from baseline to 12 weeks
|
0-12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Signe Kierkegaard, PhD, Regionshospitalet Horsens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
August 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
August 12, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Actual)
August 3, 2025
Last Update Submitted That Met QC Criteria
July 30, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-16-02-724-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pilot study with few participants.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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