Exercise Therapy for Femoroacetabular Impingement Syndrome (SWEaT)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Femoroacetabular Impingement Syndrome
• Intervention / Treatment: Other: Exercise therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicola C Casartelli, PhD; Phone Number: +41 0443857971; Email: nicola.casartelli@kws.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Recruiting
    • Schulthess Clinic
    • Contact: Nicola C Casartelli, PhD; Phone Number: +41 0443857971; Email: nicola.casartelli@kws.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise therapy; 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.	Other: Exercise therapy; Education; Hip-specific strengthening exercises; Functional lower limb strengthening exercises; Core stability exercises; Postural balance exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 6 months' follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 12 months' follow-up
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	Baseline to 3 months' follow-up
Change in hip joint contact stress	Hip joint contact pressure will be assessed using modelling	Baseline to 3 months' follow-up
Change in hip joint contact stress	Hip joint contact pressure will be assessed using modelling	Baseline to 12 months' follow-up
Hip morphology	Hip morphology will be assessed using imaging	Baseline
Change in sport activity level	Sport activity level will be assessed using the Hip Sports Activity Scale	Baseline to 3 months' follow-up
Change in sport activity level	Sport activity level will be assessed using the Hip Sports Activity Scale	Baseline to 6 months' follow-up
Change in sport activity level	Sport activity level will be assessed using the Hip Sports Activity Scale	Baseline to 12 months' follow-up
Hip surgery rate	Number of patients who will decide to undergo hip surgery	6 months' follow-up
Hip surgery rate	Number of patients who will decide to undergo hip surgery	12 months' follow-up
Dropout	Number of patients who will not complete the non-surgical intervention protocol	3 months' follow-up

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Collaborators: Kantonsspital Winterthur KSW
• Investigators: Principal Investigator: Nicola C Casartelli, PhD, Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Femoracetabular Impingement
• Other Study ID Numbers: SchulthessKlinik

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No