- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03703362
Resistance Training for Patients Diagnosed With External Snapping Hip
April 13, 2021 updated by: University of Aarhus
Resistance Training for Patients Diagnosed With External Snapping Hip. A Feasibility Study
The purpose of this study is to investigate whether targeted progressive resistance training is safe and feasible for patients with external snapping hip.
Dropout rates, adverse events and training adherence are investigated.
The secondary purpose is to investigate whether it is possible through targeted progressive resistance training to improve participants' muscle strength, functional status and hip-related quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Snapping hip (coxa saltans) is a disorder where the hip tends to make an audible click-through movement, often but not necessarily associated with pain.
A prevalence of 5-10% of the general population has been reported.
Snapping hip is divided into three forms of snapping hip; intraarticular, internal and external snapping hip.
External snapping hip (coxa saltans external) is the most common form, and patients may experience pain when the iliotibial band or anterior part of the gluteus maximus slides over the greater trochanter at femur.
Patients with external snapping hip are typically between 15 and 40 years, and physically active.
Study Type
Interventional
Enrollment (Actual)
9
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
-
-
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Aarhus, Denmark, 8000
- Aarhus University Hospital
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Horsens, Denmark, 8700
- Horsens Regional Hospital
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Silkeborg, Denmark, 8600
- Silkeborg Regional Hospital
-
-
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with Greater Trochanteric Pain Syndrome at the Orthopedic Surgery Department at Aarhus University Hospital in the period 2013-2015. In case of too few participants from this sample, we plan to include patients diagnosed during 2018
- Minimum 18 years old
- Able to read and understand Danish
- Have experienced jump/click from the outside of the hip associated with pain within the last 14 days
- Have a residence of a maximum of 55 km from Aarhus C
- The participants must not have participated in regular resistance training of the hip muscles for more than 1 day per week in the last 6 months leading up to the start of the intervention
- The participants must not have undergone a total hip replacement, a Periacetabular Osteotomy, a Z-plastic surgery or arthroscopy in the hip within 6 months before the start of the intervention or have a planned hip surgery during the intervention period
- The participants must not suffer from neurological, rheumatological, metabolic or respiratory diseases that will influence the effect of the intervention
- The participants must not have a planned vacation lasting more than 14 days during the intervention period, while not having the opportunity to extend the training period accordingly
Exclusion Criteria:
- BMI >40
- No longer suffering from external snapping hip
- Pregnancy
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: Progressive resistance training
Progressive resistance training tested in patients with external snapping hip
|
30 supervised training-sessions over 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events.
Time Frame: Measured at each training session during the 12 week intervention.
|
A muscle or joint injury caused by the training program reported by a patient, or a canceled training session due to pain associated with exercise, or other harmful incidents associated with the training program.
|
Measured at each training session during the 12 week intervention.
|
|
Pain during exercise.
Time Frame: Measured for each exercise performed during the 12 week intervention.
|
Pain during the exercises, measured by the Visual Analogue Scale (VAS).
The score range from 0-10, where 0 means no pain and 10 means maximum pain
|
Measured for each exercise performed during the 12 week intervention.
|
|
Adherence to the training.
Time Frame: Measured during the 12 week intervention.
|
Measured by how many of the training sessions the participants completed.
High adherence defined >80% of completed sessions.
Drop out is defined as a person included in the study who chooses to leave before the final test.
|
Measured during the 12 week intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle strength measured by dynamometer.
Time Frame: Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
|
Muscle strength in hip-abduction and hip-extension is measured isometrically, eccentrically and concentrically with a dynamometer (model Humac Norm).
|
Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
|
|
Change in hip function.
Time Frame: Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
|
Hip function is measured with the questionnaire the Copenhagen Hip and Groin Outcome Score (HAGOS).
HAGOS consists of 37 items in 6 subscales: 7 items to cover symptoms, 10 items to cover pain, 5 items to cover physical function in daily living, 8 items to cover physical function in sport and recreation, 2 items to cover participation in physical activities and 5 items to cover hip and groin related quality of life.
There is no total score.
Each subscale has a range from 0-100.
A high score indicates no problem and a low score indicates severe problems.
|
Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
|
|
Hypermobility status.
Time Frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
|
Hypermobility status is measured with the Beighton Score.
The test consists of 9 activities and each of the 9 tests can result in a score of 0 or 1 depending on whether the patient can perform the test or not.
A total score is summed and has a range of 0-9.
Hypermobility is defined by a score of 5 or higher.
|
Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
|
|
Change in one repetition muscle strength.
Time Frame: At the start of the intervention and 12 weeks later at the end of the intervention.
|
Muscle strength is measured with the One-Repetition-Max test for hip-abduction and leg press.
|
At the start of the intervention and 12 weeks later at the end of the intervention.
|
|
Change in hip function.
Time Frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
|
Change in hip function is measured with a Loaded stair test.
|
Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
|
|
Hip awareness.
Time Frame: Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
|
Hip awareness is measured with the Forgotten Joint Score questionnaire (FJS), where each patient completes the 12 questions regarding awareness of their affected hip.
Each question is answered with one of the following options; never, almost never, seldom, sometimes and mostly, corresponding to a score of 1-5.
The sum of the scores will be converted into a score between 0-100.
A high score will indicate lack of awareness and a low score will indicate great awareness of the affected hip.
|
Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Inger Mechlenburg, Aarhus Universitetshospital
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)
August 8, 2018
Primary Completion (Actual)
March 30, 2019
Study Completion (Actual)
March 30, 2019
Study Registration Dates
First Submitted
May 29, 2018
First Submitted That Met QC Criteria
October 5, 2018
First Posted (Actual)
October 11, 2018
Study Record Updates
Last Update Posted (Actual)
April 14, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SnappingHip
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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