Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients

Facioscapulohumeral Muscular Dystrophy Clinical Trial

Official title:

Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267354
• Other study ID #: RL1 627
• Status: Completed
• Phase: N/A
• Start date: December 14, 2016
• Est. completion date: July 18, 2018

Study information

• Verified date: February 2020
• Source: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 18, 2018
• Est. primary completion date: July 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facioscapulohumeral Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient suggestions	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.	At one-off study visit: Immediately after completion of exercise session
Other	Patient willingness to continue	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.	At one-off study visit: Immediately after completion of exercise session
Primary	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).	At one-off study visit: Prior to completion of exercise session
Secondary	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.	At one-off study visit: Prior to completion of exercise session
Secondary	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.	At one-off study visit: Prior to completion of exercise session
Secondary	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.	At one-off study visit: During exercise session
Secondary	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.	At one-off study visit: During exercise session
Secondary	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.	At one-off study visit: During exercise session
Secondary	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.	At one-off study visit: During exercise session