Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
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|ClinicalTrials.gov Identifier: NCT04267354|
Recruitment Status : Completed
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Facioscapulohumeral Muscular Dystrophy||Other: Arm cycling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients|
|Actual Study Start Date :||December 14, 2016|
|Actual Primary Completion Date :||July 14, 2018|
|Actual Study Completion Date :||July 18, 2018|
Experimental: Arm cycling
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.
Other: Arm cycling
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.
- Oxford Shoulder Score [ Time Frame: At one-off study visit: Prior to completion of exercise session ]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).
- Range of movement [ Time Frame: At one-off study visit: Prior to completion of exercise session ]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 [ Time Frame: At one-off study visit: Prior to completion of exercise session ]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 [ Time Frame: At one-off study visit: During exercise session ]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 [ Time Frame: At one-off study visit: During exercise session ]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) [ Time Frame: At one-off study visit: During exercise session ]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 [ Time Frame: At one-off study visit: During exercise session ]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.
- Patient suggestions [ Time Frame: At one-off study visit: Immediately after completion of exercise session ]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.
- Patient willingness to continue [ Time Frame: At one-off study visit: Immediately after completion of exercise session ]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.
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267354
|Principal Investigator:||Richa Kulshrestha, MBBS, MRCPCH||The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust|
|Responsible Party:||Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust|
|Other Study ID Numbers:||
|First Posted:||February 12, 2020 Key Record Dates|
|Last Update Posted:||February 12, 2020|
|Last Verified:||February 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Nervous System Diseases
Genetic Diseases, Inborn