Facioscapulohumeral Muscular DystrophyNCT04267354
Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
A study testing Arm cycling in people with Facioscapulohumeral Muscular Dystrophy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Facioscapulohumeral Muscular Dystrophy
- What is being tested?
- Arm cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2016to 18 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Being tested
- Arm cycling
- Medical subject headings
- Muscular Dystrophy, Facioscapulohumeral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm cyclingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm cycling | Experimental | 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. Receives: Other: Arm cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At one-off study visit: Prior to completion of exercise session
Secondary outcomes (6)
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.
Measured: At one-off study visit: Prior to completion of exercise session
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.
Measured: At one-off study visit: Prior to completion of exercise session
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.
Measured: At one-off study visit: During exercise session
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.
Measured: At one-off study visit: During exercise session
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.
Measured: At one-off study visit: During exercise session
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.
Measured: At one-off study visit: During exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start14 Dec 2016
- Primary completion14 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facioscapulohumeral Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Richa Kulshrestha, MBBS, MRCPCH, Principal investigator, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267354
- Sponsor's protocol ID
- RL1 627
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
- ClinicalTrials.gov ID
- NCT04267354
- Acronym / sponsor ID
- RL1 627
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 14 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm cycling | Experimental | Other: Arm cyclingParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm cyclingThe 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. | Other | Arm cycling |
Primary outcome
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).
6 secondary outcomes
Range of movement
Time frame: At one-off study visit: Prior to completion of exercise session
Strength of muscles at shoulder and elbow joints
Time frame: At one-off study visit: Prior to completion of exercise session
Resistance of arm cycling
Time frame: At one-off study visit: During exercise session
Cadence of arm cycling
Time frame: At one-off study visit: During exercise session
Borg Rate of Perceived Exertion (RPE)
Time frame: At one-off study visit: During exercise session
Video analysis
Time frame: At one-off study visit: During exercise session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richa Kulshrestha, MBBS, MRCPCH principal investigator
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Arm cycling in people with Facioscapulohumeral Muscular Dystrophy, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Shoulder Score (time frame: At one-off study visit: Prior to completion of exercise session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.