NCT03703362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

April 14, 2021

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

May 29, 2018

Last Update Submit

April 13, 2021

Conditions

Keywords

Resistance trainingFeasibility

Outcome Measures

Primary Outcomes (3)

  • 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.

    Measured at each training session during the 12 week intervention.

  • 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

    Measured for each exercise performed during the 12 week intervention.

  • 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.

    Measured during the 12 week intervention.

Secondary Outcomes (6)

  • Change in muscle strength measured by dynamometer.

    Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.

  • Change in hip function.

    Measured at inclusion, two weeks after inclusion, and when the 12 week intervention has ended.

  • Hypermobility status.

    Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.

  • Change in one repetition muscle strength.

    At the start of the intervention and 12 weeks later at the end of the intervention.

  • Change in hip function.

    Measured at inclusion, two weeks after inclusion and when the 12 week intervention has ended.

  • +1 more secondary outcomes

Study Arms (1)

Progressive resistance training

EXPERIMENTAL

Progressive resistance training tested in patients with external snapping hip

Other: Resistance training

Interventions

30 supervised training-sessions over 12 weeks

Progressive resistance training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • BMI \>40
  • No longer suffering from external snapping hip
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Inger Mechlenburg

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

October 11, 2018

Study Start

August 8, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

April 14, 2021

Record last verified: 2018-05

Locations