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the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study

Primary Purpose

Femoroacetabular Impingement

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapist-led training
Sponsored by
Horsens Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged 18-50 years old
  2. Diagnosed with FAIS according to the Warwick agreement
  3. Patients having cam morphology should have an alpha angle of > 55 degrees on an anterior-posterior radiograph.
  4. Patients having pincer should have a lateral centre edge angle of >39 degrees on an anterior-posterior radiograph.
  5. Lateral joint space width should be >3 mm.
  6. Body mass index is below 30.
  7. Motivated for participation in a 12 week training program with 8 physical attendances.

Exclusion Criteria:

  1. Received physiotherapist-led treatment in the past 3 months,
  2. Previous hip surgery in included hip or other major hip injury,
  3. Systemic conditions e.g. rheumatoid arthritis, cancer,
  4. Chronical pain syndromes,
  5. Unable to perform testing procedures,
  6. Unable to attend a 12-week treatment program or baseline and follow-up assessments
  7. Contraindications to radiographs (e.g. pregnancy)
  8. Unable to read or understand questionnaires and/or instructions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Physiotherapist-led training

    Arm Description

    Physiotherapy-led training of patients with FAIS

    Outcomes

    Primary Outcome Measures

    Number of completed exercise sessions
    Number of completed exercise sessions. A high adherence is defined as attendance of > 75% of planned sessions
    Completion of training program
    The training program is considered completed if patients are not dropping out of the study before the end of the 12 weeks. Completion rate will be calculated as % patients who completed the study

    Secondary Outcome Measures

    The Copenhagen Hip and Groin Outcome Score (HAGOS)
    HAGOS is a questionnaire developed for young, active persons experiencing hip and/or groin pain. It consists of 6 subscales: Pain, Symptoms, Activities of Daily Living, Sport, Participation in Sport and Hip-related quality of life. The main subscales used in this study are HAGOS pain and sport.
    The International Hip Outcome Tool (iHOT-33)
    iHOT-33 is a questionnaire focussing at patients' hip related quality of life in 33 questions. Both a total score and sub scales: "Symptoms and functional limitations", "Sports and recreational activities", "Job related concerns" and "Social, emotional and lifestyle concerns", are extracted from the questionnaire.
    The Hip Sports Activity Scale (HSAS)
    Current physical activity measured from 0 to 8 points, 0 being no activity and 8 being an athlete
    Maximal hip muscle strength
    Change (Nm/kg) in maximal hip flexion, extension, abduction and adduction from 0-12 weeks
    One-legged hop for distance
    Change (cm) i hop distance from 0-12 weeks
    Y-balance board
    Change (cm) in ability to perform on the y balance board from 0-12 weeks
    Patient Acceptable Symptom State
    Patient Acceptable Symptom State (yes/no): Change in number of patients reporting yes vs. no from baseline to 12 weeks

    Full Information

    First Posted
    August 12, 2021
    Last Updated
    August 26, 2021
    Sponsor
    Horsens Hospital
    Collaborators
    University of Aarhus, La Trobe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05031390
    Brief Title
    the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
    Official Title
    the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Horsens Hospital
    Collaborators
    University of Aarhus, La Trobe University

    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 aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).
    Detailed Description
    The aim of this study is to investigate the feasibility of a 12-weeks (progressive) exercise program in patients with FAIS. Feasibility is evaluated on the recruitment strategy, patient adherence to the exercises and their experiences with and motivation for performing exercises. Furthermore, the investigators wish to investigate the variation of data before and after the exercise program to help estimate a suitable sample size for a future randomized controlled trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femoroacetabular Impingement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Physiotherapist-led training
    Arm Type
    Experimental
    Arm Description
    Physiotherapy-led training of patients with FAIS
    Intervention Type
    Procedure
    Intervention Name(s)
    Physiotherapist-led training
    Intervention Description
    Patients will undergo a 12-week physiotherapist-led training program consisting of 8 supervised sessions and home-based training in between
    Primary Outcome Measure Information:
    Title
    Number of completed exercise sessions
    Description
    Number of completed exercise sessions. A high adherence is defined as attendance of > 75% of planned sessions
    Time Frame
    0-12 weeks
    Title
    Completion of training program
    Description
    The training program is considered completed if patients are not dropping out of the study before the end of the 12 weeks. Completion rate will be calculated as % patients who completed the study
    Time Frame
    0-12 weeks
    Secondary Outcome Measure Information:
    Title
    The Copenhagen Hip and Groin Outcome Score (HAGOS)
    Description
    HAGOS is a questionnaire developed for young, active persons experiencing hip and/or groin pain. It consists of 6 subscales: Pain, Symptoms, Activities of Daily Living, Sport, Participation in Sport and Hip-related quality of life. The main subscales used in this study are HAGOS pain and sport.
    Time Frame
    Change from 0-12 weeks
    Title
    The International Hip Outcome Tool (iHOT-33)
    Description
    iHOT-33 is a questionnaire focussing at patients' hip related quality of life in 33 questions. Both a total score and sub scales: "Symptoms and functional limitations", "Sports and recreational activities", "Job related concerns" and "Social, emotional and lifestyle concerns", are extracted from the questionnaire.
    Time Frame
    Change from 0-12 weeks
    Title
    The Hip Sports Activity Scale (HSAS)
    Description
    Current physical activity measured from 0 to 8 points, 0 being no activity and 8 being an athlete
    Time Frame
    Change from 0-12 weeks
    Title
    Maximal hip muscle strength
    Description
    Change (Nm/kg) in maximal hip flexion, extension, abduction and adduction from 0-12 weeks
    Time Frame
    Change from 0-12 weeks
    Title
    One-legged hop for distance
    Description
    Change (cm) i hop distance from 0-12 weeks
    Time Frame
    0-12 weeks
    Title
    Y-balance board
    Description
    Change (cm) in ability to perform on the y balance board from 0-12 weeks
    Time Frame
    0-12 weeks
    Title
    Patient Acceptable Symptom State
    Description
    Patient Acceptable Symptom State (yes/no): Change in number of patients reporting yes vs. no from baseline to 12 weeks
    Time Frame
    0-12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18-50 years old Diagnosed with FAIS according to the Warwick agreement Patients having cam morphology should have an alpha angle of > 55 degrees on an anterior-posterior radiograph. Patients having pincer should have a lateral centre edge angle of >39 degrees on an anterior-posterior radiograph. Lateral joint space width should be >3 mm. Body mass index is below 30. Motivated for participation in a 12 week training program with 8 physical attendances. Exclusion Criteria: Received physiotherapist-led treatment in the past 3 months, Previous hip surgery in included hip or other major hip injury, Systemic conditions e.g. rheumatoid arthritis, cancer, Chronical pain syndromes, Unable to perform testing procedures, Unable to attend a 12-week treatment program or baseline and follow-up assessments Contraindications to radiographs (e.g. pregnancy) Unable to read or understand questionnaires and/or instructions
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Signe Kierkegaard, PhD
    Phone
    004578427882
    Email
    signkier@rm.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Signe Kierkegaard, PhD
    Organizational Affiliation
    Regionshospitalet Horsens
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Pilot study with few participants.

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