Resistance Training for Patients Diagnosed With External Snapping Hip
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03703362|
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coxa Saltans External||Other: Resistance training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Feasibility study|
|Masking:||None (Open Label)|
|Official Title:||Resistance Training for Patients Diagnosed With External Snapping Hip. A Feasibility Study|
|Actual Study Start Date :||August 8, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: Progressive resistance training
Progressive resistance training tested in patients with external snapping hip
Other: Resistance training
30 supervised training-sessions over 12 weeks
- 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.
- 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
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703362
|Contact: Troels Kjeldsenfirstname.lastname@example.org|
|Contact: Inger Mechlenburgemail@example.com|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Principal Investigator: Inger Mechlenburg, PhD|
|Horsens Regional Hospital||Recruiting|
|Horsens, Denmark, 8700|
|Contact: Bent Lund, MD 0045 2490 1231 firstname.lastname@example.org|
|Silkeborg Regional Hospital||Recruiting|
|Silkeborg, Denmark, 8600|
|Contact: Lone R Mikkelsen, MSc. +45 8722 2851 email@example.com|
|Principal Investigator: Lone R Mikkelsen, MSc.|