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| ID | Type | Description | Link |
|---|---|---|---|
| 4308-00012B | Other Grant/Funding Number | Independent Research Fund Denmark |
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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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External snapping hip is characterised by an audible and painful snap during hip movement among physical active people around 15-40 years old. Progressive resistance training has been suggested as a new potential treatment path in treating patients with external snapping hip. The investigators conducted a feasibility study and found that patients reported less pain and improved their physical function, quality of life and muscle strength after 12 weeks of progressive resistance training. The overall aim of the project is to compare hip pain in patients with external snapping hip treated with progressive resistance training to a wait-and-see approach, in a randomised controlled trial. This study has the potential to establish a new and specific treatment option for patients with external snapping hip, to be used nationally and internationally.
This trial is an international multicentre randomised controlled assessor-blinded crossover trial, following the CONSORT guidelines. The intervention is a 12-week progressive resistance training programme, and the trial is designed with three follow-up time points. After the baseline test, the patients will be randomised in a 1:1 ratio to either the intervention or the control group using the Research Electronic Data Capture (REDCap) source hosted at Aarhus University. For both groups, the first test will be the baseline test, conducted before the randomisation. The second test will be conducted 6 weeks after randomisation, the third test will be conducted 12 weeks after randomisation and the fourth and last test will be conducted 24 weeks after randomisation. The primary outcome will be the change from baseline to the third follow-up, and the trial will be powered based on this period. The lasting effect of the intervention will be evaluated from baseline to the fourth follow-up test for the intervention group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group: Wait and see approach | Other | The control group are randomized to 12 weeks of waiting time followed by 12 weeks of progressive resistance training. |
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| Intervention group: progressive resistance training | Experimental | The intervention group are randomized to 12 weeks of progressive resistance training followed by 12 weeks of self guided exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive resistance training | Other | The progressive resistance program consist of a five-minute aerobic warm-up on either an ergometer bike, treadmill or rowing machine followed by six resistance training exercises: landmine twist, walking lunges, leg press, hip abduction, hip adduction and hip flexion. All training sessions (three per week) will be supervised for the first two weeks. After that, there will be one weekly supervised training session and two self-directed sessions. The subjects will be scheduled for 36 training sessions over 12 weeks, of which 16 will be supervised. Each training session is designed based on the findings from the feasibility study and is expected to last approximately one hour. If a subject cannot perform all scheduled sessions in a week, additional sessions will be planned for the following week to obtain the 16 supervised sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| HAGOS Pain | The HAGOS is a patient-reported questionnaire consisting of six different subscales. The pain subscale consists of 10 questions, which are all answered using standardised answer options following a 0-4-point Likert Scale. The scores are transformed into a subscale score ranging from 0 (worst) to 100 (best). A minimal clinically relevant difference of the HAGOS pain subscale has been reported to be 9.7 points among a group of patients undergoing hip arthroscopy for femoroacetabular impingement. | Baseline, week 6, week 12 and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HAGOS | The remaining five subscales of HAGOS: symptoms, function in daily living (ADL), function in sport and recreation (Sports/Rec), participation in physical activities (PA) and hip and/or groin-related quality of life (QOL). The scores are transformed into a subscale score ranging from 0 (worst) to 100 (best). | Baseline, week 6, week 12 and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-5L | The patient-reported questionnaire: the European Quality of life 5 Dimensions with 5 Levels (EQ-5D-5L) where the participant answers six questions in relation to health-related quality of life | Baseline, week 12 and week 24 |
| iPCQ |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa U Tønning, MHSc | Contact | +4526474080 | lisatoenning@clin.au.dk | |
| Inger Mechlenburg, DMSc | Contact | 4521679062 | lisatoenning@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Stig S Jakobsen, PhD | Department of Orthopedic Surgery, Aarhus University Hospital, DK | Study Director |
| Lisa U Tønning, MHSc | Department of Orthopedic Surgery, Aarhus University Hospital, DK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Universitetshospital | Not yet recruiting | Aalborg | 9000 | Denmark |
Anonymized patient-level data will be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed.
Data will be available after publication of the trial upon reasonably request.
Applications for data access will be reviewed by the author group. The applicant will be required to sign a data access agreement.
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| Waiting time | Behavioral | 12 weeks of waiting time |
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| Self guided exercise | Behavioral | 12 weeks of self guided exercise |
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| UCLA-AS | The patient-reported questionnaire: the University of California Los Angeles Activity Scale. There is only one question with 10 answers, ranging from 1 (worst) to 10 (best). | Baseline, week 12 and week 24 |
| GPE | The patient-reported questionnaire: the Global Perceived Effect, where the participant answers four questions about the effect of the treatment received. Each question has 7 possible answers, ranging from 1 (best) to 7 (worst). | Baseline, week 12 and week 24 |
| Single leg hop test | The objective measures include the single-leg hop for a distance test to test hip function. The hop distance is measured in cm. | Baseline, week 12 and week 24 |
| 30 second unilateral sit-to-stand test | The unilateral 30 second Sit to Stand test (unilateral 30STS) is a clinical test of lower extremity function. The unilateral 30STS tests how many correct repetitions of a sit to stand from a chair, a participant can complete in 30 seconds. | Baseline, week 12 and week 24 |
| Number of training sessions the participant participated in | Adherence to the exercise protocol will be evaluated based on information from the physiotherapists and a self-reported training diary. Good adherence will be defined as participation in more than ≥70% of all training sessions (both supervised and self-training). | Throughout the study, summed in week 24 |
| Adverse events | The physiotherapist will record any adverse events occurring during the study period. | Throughout the study, summed in week 24 |
The patient-reported questionnaire: the Productivity Costs Questionnaire, where information on productivity is collected .
| Baseline, week 12 and week 24 |
| HUQ | Health Utilisation Questionnaire (HUQ) where information on healthcare and medicine is collected. | Baseline, week 12 and week 24 |
| Usage of analgesics due to hip-related pain | The participants will be asked if they take any analgesics due to hip-related pain. If yes, they will be further asked what type of medicine (Paracetamol/NSAID/Morfin/Other) and how often (Never/Monthly/Weekly/Daily). | Baseline, week 12 and week 24 |
| Inger Mechlenburg, DMSc | Department of Clinical Medicine, Aarhus University, DK | Study Director |
| Ulrik Dalgas, PhD | Department of Public Health, Sports, Aarhus University, DK | Study Director |
| Troels Kjeldsen, PhD | Department of Orthopedic Surgery, Aarhus University Hospital, DK | Study Director |
| Cara Lewis, PhD | Department of Physical Therapy, Boston University, Boston, US | Study Director |
| Martin Lamm, MSc | Department of Orthopedic Surgery, Aarhus University Hospital, DK | Study Director |
| Joanne L Kemp, PhD | La Trobe Sport and Exercise Medicine Research Centre, La Trobe University, Melbourne, Australia | Study Director |
| Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
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| Rigshospitalet | Not yet recruiting | Copenhagen | 2100 | Denmark |
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| Bispebjerg og Frederiksberg Hospital | Not yet recruiting | Copenhagen | 2400 | Denmark |
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| Regionshospitalet Gødstrup | Not yet recruiting | Herning | 7400 | Denmark |
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| Nordsjællands Hospital - Hillerød | Not yet recruiting | Hillerød | 3400 | Denmark |
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| Regionshospitalet Horsens | Recruiting | Horsens | 8700 | Denmark |
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| Hvidovre Hospital | Not yet recruiting | Hvidovre | 2650 | Denmark |
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| Sjællands Universitetshospital - Køge | Not yet recruiting | Køge | 4600 | Denmark |
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| Næstved, Slagelse og Ringsted Hospital | Not yet recruiting | Næstved | 4700 | Denmark |
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| Odense Universitetshospital | Not yet recruiting | Odense | 5000 | Denmark |
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| Regionshospitalet Randers | Not yet recruiting | Randers | 8930 | Denmark |
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| Sygehus Lillebælt - Vejle | Not yet recruiting | Vejle | 7100 | Denmark |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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