Femoroacetabular Impingement SyndromeSWEaTNCT04502043
Exercise Therapy for Femoroacetabular Impingement Syndrome
A study testing Exercise therapy in people with Femoroacetabular Impingement Syndrome, run by Schulthess Klinik at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femoroacetabular Impingement Syndrome
- What is being tested?
- Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2019to Mar 2024
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Schulthess Clinic
Zurich, 8008
Nicola C Casartelli, PhD, 0443857971 ext. +41, nicola.casartelli@kws.ch
About this study
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
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).
Read the 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.
- Conditions
- Femoroacetabular Impingement Syndrome
- Being tested
- Exercise therapy
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
- Education
- Hip-specific strengthening exercises
- Functional lower limb strengthening exercises
- Core stability exercises
- Postural balance exercises
| Study group | Role | What they receive |
|---|---|---|
| Exercise therapy | Experimental | 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. Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 6 months' follow-up
Secondary outcomes (11)
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
Measured: 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
Measured: Baseline to 3 months' follow-up
Change in hip joint contact stress
Hip joint contact pressure will be assessed using modelling
Measured: Baseline to 3 months' follow-up
Change in hip joint contact stress
Hip joint contact pressure will be assessed using modelling
Measured: Baseline to 12 months' follow-up
Hip morphology
Hip morphology will be assessed using imaging
Measured: Baseline
Change in sport activity level
Sport activity level will be assessed using the Hip Sports Activity Scale
Measured: Baseline to 3 months' follow-up
Change in sport activity level
Sport activity level will be assessed using the Hip Sports Activity Scale
Measured: Baseline to 6 months' follow-up
Change in sport activity level
Sport activity level will be assessed using the Hip Sports Activity Scale
Measured: Baseline to 12 months' follow-up
Hip surgery rate
Number of patients who will decide to undergo hip surgery
Measured: 6 months' follow-up
Hip surgery rate
Number of patients who will decide to undergo hip surgery
Measured: 12 months' follow-up
Dropout
Number of patients who will not complete the non-surgical intervention protocol
Measured: 3 months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Aug 2019
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular Impingement SyndromeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW
- Responsible party
- Sponsor
- Investigators
- Nicola C Casartelli, PhD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502043
- Sponsor's protocol ID
- SchulthessKlinik
- Acronym
- SWEaT
- Status last verified
- Dec 2023
- First submitted
- 14 Jun 2019
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04502043
- Acronym / sponsor ID
- SWEaT / SchulthessKlinik
- Conditions
- Femoroacetabular Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Kantonsspital Winterthur KSW
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Aug 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy | Experimental | Other: Exercise therapyExercise therapy consists of improving dynamic hip joint stability by means of hip-specific and functional lower limb strengthening, core stability and postural balance exercises. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Exercise therapy* Education * Hip-specific strengthening exercises * Functional lower limb strengthening exercises * Core stability exercises * Postural balance exercises | Other | Exercise therapy |
Primary outcome
Change in hip pain, function and quality of life
Time frame: Baseline to 6 months' follow-up
Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items
11 secondary outcomes
Change in hip pain, function and quality of life
Time frame: Baseline to 12 months' follow-up
Change in hip pain, function and quality of life
Time frame: Baseline to 3 months' follow-up
Change in hip joint contact stress
Time frame: Baseline to 3 months' follow-up
Change in hip joint contact stress
Time frame: Baseline to 12 months' follow-up
Hip morphology
Time frame: Baseline
Change in sport activity level
Time frame: Baseline to 3 months' follow-up
Change in sport activity level
Time frame: Baseline to 6 months' follow-up
Change in sport activity level
Time frame: Baseline to 12 months' follow-up
Hip surgery rate
Time frame: 6 months' follow-up
Hip surgery rate
Time frame: 12 months' follow-up
Dropout
Time frame: 3 months' follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
Nicola C Casartelli, PhD principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy in people with Femoroacetabular Impingement Syndrome, run by Schulthess Klinik at 1 site in Switzerland.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola C Casartelli, PhD (0443857971 ext. +41, nicola.casartelli@kws.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hip pain, function and quality of life (time frame: Baseline to 6 months' follow-up). 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 19 Dec 2023.