Exercise Therapy for Femoroacetabular Impingement Syndrome (SWEaT)
Primary Purpose
Femoroacetabular Impingement Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Femoroacetabular Impingement Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age: 18 to 50 years;
- Diagnosis of FAIS;
- Availability of magnetic resonance arthrography and anteroposterior pelvic radiography of the involved hip;
- Signed informed consent form.
Exclusion Criteria:
- Previous hip surgery;
- Any surgery on the lower extremities in the last 6 months;
- Hip dysplasia: lateral center edge angle <25°;
- Hip osteoarthritis: Tönnis grade >1;
- BMI: >35 kg/m2;
- Significant cardiopulmonary diseases.
Sites / Locations
- Schulthess ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise therapy
Arm Description
Exercise therapy consists of improving dynamic hip joint stability by means of hip-specific and functional lower limb strengthening, core stability and postural balance exercises.
Outcomes
Primary Outcome Measures
Change in hip pain, function and quality of life
Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
Secondary Outcome Measures
Change in hip pain, function and quality of life
Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
Change in hip pain, function and quality of life
Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
Change in hip joint contact stress
Hip joint contact pressure will be assessed using modelling
Change in hip joint contact stress
Hip joint contact pressure will be assessed using modelling
Hip morphology
Hip morphology will be assessed using imaging
Change in sport activity level
Sport activity level will be assessed using the Hip Sports Activity Scale
Change in sport activity level
Sport activity level will be assessed using the Hip Sports Activity Scale
Change in sport activity level
Sport activity level will be assessed using the Hip Sports Activity Scale
Hip surgery rate
Number of patients who will decide to undergo hip surgery
Hip surgery rate
Number of patients who will decide to undergo hip surgery
Dropout
Number of patients who will not complete the non-surgical intervention protocol
Full Information
NCT ID
NCT04502043
First Posted
June 14, 2019
Last Updated
October 25, 2022
Sponsor
Schulthess Klinik
Collaborators
Kantonsspital Winterthur KSW
1. Study Identification
Unique Protocol Identification Number
NCT04502043
Brief Title
Exercise Therapy for Femoroacetabular Impingement Syndrome
Acronym
SWEaT
Official Title
The Effect of Patients' Characteristics on the Responsiveness to Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: a Multi-center, Single-group, Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schulthess Klinik
Collaborators
Kantonsspital Winterthur KSW
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the clinical trial is to investigate the characteristics of patients, who respond vs. not respond to exercise therapy for the nonsurgical management of femoroacetabular impingement syndrome (FAIS).
Detailed Description
Patients with a diagnosis of FAIS will be recruited from 2 clinical centers and will receive exercise therapy (study intervention). Exercise therapy is a semi-standardized intervention and will last 12 weeks (3 months). Hip pain, function and quality of life will be assessed using a patient-reported questionnaire at baseline, 3, 6 and 12 months' follow-up. Hip joint contact pressure will be evaluated using motion analysis and modelling at baseline, 3 and 12 months' follow-up. Hip morphology will be evaluated using imaging at baseline and hip surgery rate will be evaluated at 6 and 12 months' follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise therapy
Arm Type
Experimental
Arm Description
Exercise therapy consists of improving dynamic hip joint stability by means of hip-specific and functional lower limb strengthening, core stability and postural balance exercises.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
Education
Hip-specific strengthening exercises
Functional lower limb strengthening exercises
Core stability exercises
Postural balance exercises
Primary Outcome Measure Information:
Title
Change in hip pain, function and quality of life
Description
Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
Time Frame
Baseline to 6 months' follow-up
Secondary Outcome Measure Information:
Title
Change in hip pain, function and quality of life
Description
Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
Time Frame
Baseline to 12 months' follow-up
Title
Change in hip pain, function and quality of life
Description
Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
Time Frame
Baseline to 3 months' follow-up
Title
Change in hip joint contact stress
Description
Hip joint contact pressure will be assessed using modelling
Time Frame
Baseline to 3 months' follow-up
Title
Change in hip joint contact stress
Description
Hip joint contact pressure will be assessed using modelling
Time Frame
Baseline to 12 months' follow-up
Title
Hip morphology
Description
Hip morphology will be assessed using imaging
Time Frame
Baseline
Title
Change in sport activity level
Description
Sport activity level will be assessed using the Hip Sports Activity Scale
Time Frame
Baseline to 3 months' follow-up
Title
Change in sport activity level
Description
Sport activity level will be assessed using the Hip Sports Activity Scale
Time Frame
Baseline to 6 months' follow-up
Title
Change in sport activity level
Description
Sport activity level will be assessed using the Hip Sports Activity Scale
Time Frame
Baseline to 12 months' follow-up
Title
Hip surgery rate
Description
Number of patients who will decide to undergo hip surgery
Time Frame
6 months' follow-up
Title
Hip surgery rate
Description
Number of patients who will decide to undergo hip surgery
Time Frame
12 months' follow-up
Title
Dropout
Description
Number of patients who will not complete the non-surgical intervention protocol
Time Frame
3 months' follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 to 50 years;
Diagnosis of FAIS;
Availability of magnetic resonance arthrography and anteroposterior pelvic radiography of the involved hip;
Signed informed consent form.
Exclusion Criteria:
Previous hip surgery;
Any surgery on the lower extremities in the last 6 months;
Hip dysplasia: lateral center edge angle <25°;
Hip osteoarthritis: Tönnis grade >1;
BMI: >35 kg/m2;
Significant cardiopulmonary diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola C Casartelli, PhD
Phone
0443857971
Ext
+41
Email
nicola.casartelli@kws.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola C Casartelli, PhD
Organizational Affiliation
Schulthess Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schulthess Clinic
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola C Casartelli, PhD
Phone
0443857971
Ext
+41
Email
nicola.casartelli@kws.ch
12. IPD Sharing Statement
Learn more about this trial
Exercise Therapy for Femoroacetabular Impingement Syndrome
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