Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients

NCT ID: NCT04267354

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-14
• Study Completion Date: 2018-07-18

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.

Conditions

Facioscapulohumeral Muscular Dystrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Arm cycling

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richa Kulshrestha, MBBS, MRCPCH

Role: PRINCIPAL_INVESTIGATOR

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Other Identifiers

RL1 627

Identifier Type: -

Identifier Source: org_study_id