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Resistance Training for Patients Diagnosed With External Snapping Hip

Primary Purpose

Coxa Saltans External

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coxa Saltans External focused on measuring Resistance training, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital
  • Horsens Regional Hospital
  • Silkeborg Regional Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Progressive resistance training

Arm Description

Progressive resistance training tested in patients with external snapping hip

Outcomes

Primary Outcome Measures

Adverse events.
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.
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.
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.

Secondary Outcome Measures

Change in muscle strength measured by dynamometer.
Muscle strength in hip-abduction and hip-extension is measured isometrically, eccentrically and concentrically with a dynamometer (model Humac Norm).
Change in hip function.
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.
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.
Muscle strength is measured with the One-Repetition-Max test for hip-abduction and leg press.
Change in hip function.
Change in hip function is measured with a Loaded stair test.
Hip awareness.
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.

Full Information

First Posted
May 29, 2018
Last Updated
April 13, 2021
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03703362
Brief Title
Resistance Training for Patients Diagnosed With External Snapping Hip
Official Title
Resistance Training for Patients Diagnosed With External Snapping Hip. A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxa Saltans External
Keywords
Resistance training, Feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive resistance training
Arm Type
Experimental
Arm Description
Progressive resistance training tested in patients with external snapping hip
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
30 supervised training-sessions over 12 weeks
Primary Outcome Measure Information:
Title
Adverse events.
Description
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.
Time Frame
Measured at each training session during the 12 week intervention.
Title
Pain during exercise.
Description
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
Time Frame
Measured for each exercise performed during the 12 week intervention.
Title
Adherence to the training.
Description
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.
Time Frame
Measured during the 12 week intervention.
Secondary Outcome Measure Information:
Title
Change in muscle strength measured by dynamometer.
Description
Muscle strength in hip-abduction and hip-extension is measured isometrically, eccentrically and concentrically with a dynamometer (model Humac Norm).
Time Frame
Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
Title
Change in hip function.
Description
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.
Time Frame
Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.
Title
Hypermobility status.
Description
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.
Time Frame
Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
Title
Change in one repetition muscle strength.
Description
Muscle strength is measured with the One-Repetition-Max test for hip-abduction and leg press.
Time Frame
At the start of the intervention and 12 weeks later at the end of the intervention.
Title
Change in hip function.
Description
Change in hip function is measured with a Loaded stair test.
Time Frame
Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.
Title
Hip awareness.
Description
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.
Time Frame
Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inger Mechlenburg
Organizational Affiliation
Aarhus Universitetshospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Horsens Regional Hospital
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Silkeborg Regional Hospital
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark

12. IPD Sharing Statement

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Resistance Training for Patients Diagnosed With External Snapping Hip

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