Progressive Resistance Training for Adults With External Snapping Hip (Snappy Hip)
Snappy Hip Trial: A Randomized Crossover Trial Comparing the Clinical and Cost-effectiveness of Progressive Resistance Training Compared to Usual Care on Pain for Adults With External Snapping Hip
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Lisa U Tønning, MHSc
- Phone Number: +4526474080
- Email: lisatoenning@clin.au.dk
Study Contact Backup
- Name: Inger Mechlenburg, DMSc
- Phone Number: 4521679062
- Email: lisatoenning@clin.au.dk
Study Locations
-
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Aalborg, Denmark, 9000
- Not yet recruiting
- Aalborg Universitetshospital
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Contact:
- Jens Kristinsson
- Phone Number: 004597660000
- Email: hjk@rn.dk
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Aarhus N, Denmark, 8200
- Recruiting
- Aarhus University Hospital
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Contact:
- Inger Mechlenburg, DMSc
- Phone Number: +4521679062
- Email: inger.mechlenburg@clin.au.dk
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Contact:
- Lisa U Tønning, PhD
- Phone Number: +4526474080
- Email: lisatoenning@clin.au.dk
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Principal Investigator:
- Lisa U Tønning, MHSc
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Copenhagen, Denmark, 2400
- Not yet recruiting
- Bispebjerg og Frederiksberg Hospital
-
Contact:
- Søren Overgaard
- Phone Number: 004538635000
- Email: soeren.overgaard@regionh.dk
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Copenhagen, Denmark, 2100
- Not yet recruiting
- Rigshospitalet
-
Contact:
- Peter Horstmann
- Phone Number: 004535453545
- Email: peter.frederik.horstmann.02@regionh.dk
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Herning, Denmark, 7400
- Not yet recruiting
- Regionshospitalet Gødstrup
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Contact:
- Christina F Frandsen
- Phone Number: 004578430000
- Email: chrifroe@rm.dk
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Hillerød, Denmark, 3400
- Not yet recruiting
- Nordsjællands Hospital - Hillerød
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Contact:
- Samir Sarvan
- Phone Number: 004548294829
- Email: samir.sarvan@regionh.dk
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Horsens, Denmark, 8700
- Recruiting
- Regionshospitalet Horsens
-
Contact:
- Jeppe Lange, PhD
- Phone Number: 004578425000
- Email: jeppe.lange@clin.au.dk
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Hvidovre, Denmark, 2650
- Not yet recruiting
- Hvidovre Hospital
-
Contact:
- Per Hölmich
- Phone Number: 0045 38623862
- Email: per.hoelmich@regionh.dk
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Køge, Denmark, 4600
- Not yet recruiting
- Sjællands Universitetshospital - Køge
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Contact:
- Eva Wetke
- Phone Number: 004556631500
- Email: ewe@regionsjaelland.dk
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Næstved, Denmark, 4700
- Not yet recruiting
- Næstved, Slagelse og Ringsted Hospital
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Contact:
- Henrik Vilsner
- Phone Number: 004556512000
- Email: hvl@regionsjaelland.dk
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Odense, Denmark, 5000
- Not yet recruiting
- Odense Universitetshospital
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Contact:
- Louise D Petersen
- Phone Number: 004566113333
- Email: louise.dyhring.petersen@rsyd.dk
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Randers, Denmark, 8930
- Not yet recruiting
- Regionshospitalet Randers
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Contact:
- Daniel Wæver
- Phone Number: 004578420000
- Email: DANWAE@rm.dk
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Vejle, Denmark, 7100
- Not yet recruiting
- Sygehus Lillebælt - Vejle
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Contact:
- Henriette Holm
- Phone Number: 004579405000
- Email: Henriette.Bruhn.Appel.Holm@rsyd.dk
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Age 18-40 years (10)
- Experienced lateral hip joint "snapping" with pain discomfort within the last 14 days
- Able to demonstrate the audible and/or visible lateral "snapping" during lateral hip joint movementor popping sound when the hip joint moves
- Capable of commuting to the training facility
- Proficient in reading and understanding Danish or English
Exclusion criteria:
- Previous surgery on the affected hip
- Planned surgery on lower extremities within the trial period
- Anterior or medial hip discomfort that substantially exceeds the lateral hip discomfort
- Any contraindication to exercise
- Neurological, rheumatoid, or mental conditions affecting the hip function
- Ongoing active cancer treatment
- Planned vacation for more than 14 days within the intervention period
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Control group: Wait and see approach
The control group are randomized to 12 weeks of waiting time followed by 12 weeks of progressive resistance training.
|
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.
Other Names:
12 weeks of waiting time
Other Names:
|
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Experimental: Intervention group: progressive resistance training
The intervention group are randomized to 12 weeks of progressive resistance training followed by 12 weeks of self guided exercise
|
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.
Other Names:
12 weeks of self guided exercise
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HAGOS Pain
Time Frame: Baseline, week 6, week 12 and week 24
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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.
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Baseline, week 6, week 12 and week 24
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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UCLA-AS
Time Frame: Baseline, week 12 and week 24
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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).
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Baseline, week 12 and week 24
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GPE
Time Frame: Baseline, week 12 and week 24
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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).
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Baseline, week 12 and week 24
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Single leg hop test
Time Frame: Baseline, week 12 and week 24
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The objective measures include the single-leg hop for a distance test to test hip function.
The hop distance is measured in cm.
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Baseline, week 12 and week 24
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30 second unilateral sit-to-stand test
Time Frame: Baseline, week 12 and week 24
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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.
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Baseline, week 12 and week 24
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Number of training sessions the participant participated in
Time Frame: Throughout the study, summed in week 24
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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).
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Throughout the study, summed in week 24
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Adverse events
Time Frame: Throughout the study, summed in week 24
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The physiotherapist will record any adverse events occurring during the study period.
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Throughout the study, summed in week 24
|
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HAGOS
Time Frame: Baseline, week 6, week 12 and week 24
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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
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EQ-5D-5L
Time Frame: Baseline, week 12 and week 24
|
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
|
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iPCQ
Time Frame: Baseline, week 12 and week 24
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The patient-reported questionnaire: the Productivity Costs Questionnaire, where information on productivity is collected .
|
Baseline, week 12 and week 24
|
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HUQ
Time Frame: Baseline, week 12 and week 24
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Health Utilisation Questionnaire (HUQ) where information on healthcare and medicine is collected.
|
Baseline, week 12 and week 24
|
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Usage of analgesics due to hip-related pain
Time Frame: Baseline, week 12 and week 24
|
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).
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Baseline, week 12 and week 24
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Stig S Jakobsen, PhD, Department of Orthopedic Surgery, Aarhus University Hospital, DK
- Principal Investigator: Lisa U Tønning, MHSc, Department of Orthopedic Surgery, Aarhus University Hospital, DK
- Study Director: 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 record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Snappy Hip Tirial
- 4308-00012B (Other Grant/Funding Number: Independent Research Fund Denmark)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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