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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
      • Horsens, Denmark, 8700
        • Horsens Regional Hospital
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Progressive resistance training
Progressive resistance training tested in patients with external snapping hip
Other: Resistance training
30 supervised training-sessions over 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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