Arm cycling in FSHD
Research type
Research Study
Full title
Arm cycling in Facioscapulohumeral Dystrophy (FSHD) patients
IRAS ID
211391
Contact name
Tracey Willis
Contact email
Clinicaltrials.gov Identifier
researchregistry1408, Researchregistry.com
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Summary of Research
This study will take part in two stages. Stage one aims to test our hypothesis that shoulder muscle weakness and reduced range of movements at upper limb joints would not affect arm cycling ability of FSHD patients. Twenty FSHD patients will be invited to attend the RJAH Orthopaedic Hospital for a single session lasting approximately 2 hours. Firstly the range of passive and active movements at participant's shoulder and elbow joints will be measured and the Oxford Shoulder Score (OSS) completed. The OSS is a 12 item shoulder instability validated questionnaire used to assess the degree of pain and disability caused by shoulder pathology. The participants will then perform arm cycling using a table-top arm cycler. Cadence, resistance and arm cycling duration of the exercise will be determined as per each individual's tolerance.
Following the exercise session, the following measures will be assessed:
•Patient rating of perceived exertion (‘effort’) during arm cycling
•Patient selected resistance and cadence (both relate to the intensity of cycling)
•Subjective description of ease of doing arm cycling.
•Patient suggestions about factors that limit their performance.
•Video analysis of shoulder and elbow joint angles during arm cycling.The second stage will be to measure FSHD patient muscle strength and movement (as well as muscle morphology as measured by magnetic resonance imaging (MRI)) both before and after a 12 week at-home arm cycling exercise programme. We aim to assess whether the exercise programme has improved or maintained strength and function. This will also test whether arm cycling is a feasible exercise in this patient group.
In this current application, we are applying for ethical approval of stage one only. We plan to then use the results gathered from stage one to help in the design and application for funding and ethical approval of stage two.
Summary of Results
WHO?
We recruited 15 adults (9 females and 6 males) with FSHD into the study, aged 18-60 years (mean age 44 years).
WHAT?
• Each participant attended RJAH and completed a questionnaire on shoulder ability (the Oxford Shoulder Score), range of movement and muscle strength of the shoulder and elbow measured.
• Participants then completed supervised arm cycling using a table-top arm cycler.
• Participants started cycling with low resistance and increased speed and resistance as tolerated, for a maximum cycling period of two minutes. Five cycle periods were performed with a rest of 30 seconds between.
• Participant rating of effort required was recorded for each cycle.
• Four days after the assessment, participants were contacted to see if any discomfort was felt following the exercise.
RESULTS
• All participants completed the study
assessments
• No adverse effects were seen by any of the participants in the study • Participants with greater muscle strength cycled at higher speed • Participants with greater Oxford Shoulder Score results cycled faster • This study confirmed that arm cycling is a feasible exercise for people with FSHD Graph showing average arm cycling speed compared to Oxford Shoulder Score. Each dot represents a participant WHAT’S NEXT?
• We now plan to design a larger trial to assess whether arm cycling provides muscular and/or cardiovascular benefit to people with FSHD • We expect that the future trial will compare the arm function and strength in two groups of people with FSHD:
─ Group 1: Completing a 12-week at-home
arm cycling exercise programme
─ Group 2: Not completing the exercise
programme
Both groups will have regular functional, strength and cardiovascular assessments This study was funded by the Orthopaedic Institute LtdREC name
North West - Greater Manchester East Research Ethics Committee
REC reference
16/NW/0673
Date of REC Opinion
5 Oct 2016
REC opinion
Favourable Opinion