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Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients

Primary Purpose

Facioscapulohumeral Muscular Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arm cycling
Sponsored by
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facioscapulohumeral Muscular Dystrophy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-60 years
  2. Genetically confirmed diagnosis of FSHD
  3. Willing to attend the assessment session
  4. Able to understand the participant information sheet and provide written informed consent

Exclusion Criteria:

  1. Aged <18 years or >60 years
  2. Co-morbidity that would affect their ability to perform arm cycling
  3. Unwilling to complete the assessments of the study
  4. Unable to understand the participant information sheet and provide written informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm cycling

    Arm Description

    Participants will perform arm cycling using a table-top arm cycler. Cadence and resistance of the exercise will be determined as per each individual's tolerance. All exercise will be supervised by the neuromuscular specialist physio, to ensure it is completed safely. Participants will be able to have plenty of breaks during the assessments.

    Outcomes

    Primary Outcome Measures

    Oxford Shoulder Score
    A 12 item patient-reported shoulder instability questionnaire. Each of the questions presents five possible responses corresponding to a score of 0 (most disability/pain) to 4 (least disability/pain). when the twelve items are summed, the questionnaire then produces a single score with a range from 0 (most disability/pain) to 48 (least disability/pain).

    Secondary Outcome Measures

    Range of movement
    A physiotherapist-assessed score of amount of movement at a joint in degrees, using goniometer. Range of movement is measured for both left and right shoulder joints in abduction, flexion and extension. Range of movement is measured for both left and right elbow joints in flexion and extension.
    Strength of muscles at shoulder and elbow joints
    Assessment of muscle strength at at shoulder and elbow joints, by physiotherapist using a hand held dynamometer device. Using the dynamometer, the physiotherapist pushes against the joint and the patient resists. The dynamometer then provides a strength reading in Newton Metres of Torque. Both left and right shoulders will be assessed in abduction, flexion and extension. Both left and right elbows will be assessed in extension and flexion.
    Resistance of arm cycling
    Patients will be asked to complete the arm cycling exercise at whatever resistance they feel most comfortable. Chosen resistance will be recorded.
    Cadence of arm cycling
    Patients will be asked to complete the arm cycling exercise at whatever speed they feel most comfortable. The chosen cadence (speed) in cycles per minute will be recorded.
    Borg Rate of Perceived Exertion (RPE)
    A patient-reported score of effort during exercise. The score ranges from 6 (no exertion at all) to 20 (maximal exertion). Patients will be asked to exercise at a level that is comfortable to them and indicate which RPE score they feel that they are working to, for each cycle of the arm cycling exercise.
    Video analysis
    Video analysis of shoulder and elbow joint angles during arm cycling. Analysis software will be used to measure patient wrist, elbow and shoulder flexion and extension as well as trunk orientation during the exercise session.

    Full Information

    First Posted
    February 4, 2020
    Last Updated
    February 11, 2020
    Sponsor
    Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04267354
    Brief Title
    Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
    Official Title
    Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 14, 2016 (Actual)
    Primary Completion Date
    July 14, 2018 (Actual)
    Study Completion Date
    July 18, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

    4. Oversight

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

    5. Study Description

    Brief Summary
    The investigators believe that arm cycling has the potential to be effective in maintaining or improving shoulder muscle functioning. However, there is no evidence for its safety or effectiveness in the upper extremity. The aim of the study is to establish the ability of FSHD sufferers to perform arm cycling to underpin the future design of an arm exercise trial. The study hypothesis is that the limited range of shoulder movement and muscle weakness should not impact the ability of FSHD sufferers to perform arm cycling.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Facioscapulohumeral Muscular Dystrophy

    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 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm cycling
    Arm Type
    Experimental
    Arm Description
    Participants will perform arm cycling using a table-top arm cycler. Cadence and resistance of the exercise will be determined as per each individual's tolerance. All exercise will be supervised by the neuromuscular specialist physio, to ensure it is completed safely. Participants will be able to have plenty of breaks during the assessments.
    Intervention Type
    Other
    Intervention Name(s)
    Arm cycling
    Intervention Description
    The arm cycle will be placed on table with height adjusted to be the same as the acromion (highest point on shoulder). Participants will start arm cycling at a low intensity and increase as per tolerance. They will exercise for a maximum of two minutes at a time, followed by a rest period for 30 seconds. In this manner 5 cycles of exercise and rest will be performed. The exercise sessions are anticipated to last a maximum of 20 minutes, depending on the patient's abilities.
    Primary Outcome Measure Information:
    Title
    Oxford Shoulder Score
    Description
    A 12 item patient-reported shoulder instability questionnaire. Each of the questions presents five possible responses corresponding to a score of 0 (most disability/pain) to 4 (least disability/pain). when the twelve items are summed, the questionnaire then produces a single score with a range from 0 (most disability/pain) to 48 (least disability/pain).
    Time Frame
    At one-off study visit: Prior to completion of exercise session
    Secondary Outcome Measure Information:
    Title
    Range of movement
    Description
    A physiotherapist-assessed score of amount of movement at a joint in degrees, using goniometer. Range of movement is measured for both left and right shoulder joints in abduction, flexion and extension. Range of movement is measured for both left and right elbow joints in flexion and extension.
    Time Frame
    At one-off study visit: Prior to completion of exercise session
    Title
    Strength of muscles at shoulder and elbow joints
    Description
    Assessment of muscle strength at at shoulder and elbow joints, by physiotherapist using a hand held dynamometer device. Using the dynamometer, the physiotherapist pushes against the joint and the patient resists. The dynamometer then provides a strength reading in Newton Metres of Torque. Both left and right shoulders will be assessed in abduction, flexion and extension. Both left and right elbows will be assessed in extension and flexion.
    Time Frame
    At one-off study visit: Prior to completion of exercise session
    Title
    Resistance of arm cycling
    Description
    Patients will be asked to complete the arm cycling exercise at whatever resistance they feel most comfortable. Chosen resistance will be recorded.
    Time Frame
    At one-off study visit: During exercise session
    Title
    Cadence of arm cycling
    Description
    Patients will be asked to complete the arm cycling exercise at whatever speed they feel most comfortable. The chosen cadence (speed) in cycles per minute will be recorded.
    Time Frame
    At one-off study visit: During exercise session
    Title
    Borg Rate of Perceived Exertion (RPE)
    Description
    A patient-reported score of effort during exercise. The score ranges from 6 (no exertion at all) to 20 (maximal exertion). Patients will be asked to exercise at a level that is comfortable to them and indicate which RPE score they feel that they are working to, for each cycle of the arm cycling exercise.
    Time Frame
    At one-off study visit: During exercise session
    Title
    Video analysis
    Description
    Video analysis of shoulder and elbow joint angles during arm cycling. Analysis software will be used to measure patient wrist, elbow and shoulder flexion and extension as well as trunk orientation during the exercise session.
    Time Frame
    At one-off study visit: During exercise session
    Other Pre-specified Outcome Measures:
    Title
    Patient suggestions
    Description
    A free-text questionnaire asking patients to report any suggestions that they may have regarding factors that may limit their performance during this type of exercise, particularly if it were to be completed at home. There is no score for this question.
    Time Frame
    At one-off study visit: Immediately after completion of exercise session
    Title
    Patient willingness to continue
    Description
    A free-text questionnaire asking patients to report whether they would be willing to continue with this sort of exercise at home, should it be proved effective. There is no score for this question.
    Time Frame
    At one-off study visit: Immediately after completion of exercise session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18-60 years Genetically confirmed diagnosis of FSHD Willing to attend the assessment session Able to understand the participant information sheet and provide written informed consent Exclusion Criteria: Aged <18 years or >60 years Co-morbidity that would affect their ability to perform arm cycling Unwilling to complete the assessments of the study Unable to understand the participant information sheet and provide written informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richa Kulshrestha, MBBS, MRCPCH
    Organizational Affiliation
    The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients

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