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
About this trial
This is an interventional treatment trial for Facioscapulohumeral Muscular Dystrophy
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.
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
NCT ID
NCT04267354
First Posted
February 4, 2020
Last Updated
February 11, 2020
Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
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
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Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
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