Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients

NCT04267354 | Completed

• 1 other identifier: RL1 627
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Range of movement

  At one-off study visit: Prior to completion of exercise session

• Strength of muscles at shoulder and elbow joints

  At one-off study visit: Prior to completion of exercise session

• Resistance of arm cycling

  At one-off study visit: During exercise session

• Cadence of arm cycling

  At one-off study visit: During exercise session

• Borg Rate of Perceived Exertion (RPE)

  At one-off study visit: During exercise session

Other Outcomes (2)

• Patient suggestions

  At one-off study visit: Immediately after completion of exercise session

• Patient willingness to continue

  At one-off study visit: Immediately after completion of exercise session

Study Arms (1)

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.

Other: Arm cycling

Interventions

Arm cycling 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.

Arm cycling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

MeSH Terms

Conditions

Muscular Dystrophy, Facioscapulohumeral

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Richa Kulshrestha, MBBS, MRCPCH

  The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 12, 2020
• Study Start: December 14, 2016
• Primary Completion: July 14, 2018
• Study Completion: July 18, 2018
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share