the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study

Study Overview
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Brief Summary
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The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).

Detailed Description
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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.

Official Title
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the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study

Conditions
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Femoroacetabular Impingement

Intervention / Treatment
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* Procedure: Physiotherapist-led training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapist-led training<br>Physiotherapy-led training of patients with FAIS | Procedure: Physiotherapist-led training<br>* Patients will undergo a 12-week physiotherapist-led training program consisting of 8 supervised sessions and home-based training in between<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of completed exercise sessions | Number of completed exercise sessions. A high adherence is defined as attendance of > 75% of planned sessions | 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 | 0-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | Change from 0-12 weeks | 
| Maximal hip muscle strength | 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 | Change (cm) i hop distance from 0-12 weeks | 0-12 weeks | 
| Y-balance board | Change (cm) in ability to perform on the y balance board from 0-12 weeks | 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 | 0-12 weeks |