6 minutes assisted leg and arm cycling test: feasibility, validity, test-retest responsivity and responsivity in patients with neuromuscular and metabolic disorders

Recruiting

• Conditions: congenital neuromusclar disease; muscle diseases; 10028396; 10021605; 10029317

• Registration Number: NL-OMON35872
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

Dependent on the disease, see paragraph 4.1 for more information.
General criteria:
6-18 years old

Exclusion Criteria

Dependent on the disease, see paragraph 4.1 for more information.
General criteria:
Sever cardiomyopathy
Severe behavioural problems
High likelihood of falls
Hemiparesis

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of successful tests (see definition in Chapter 2): feasibility<br /><br>Number of revolutions cycled in 6 minutes on the Dynamic bicycle: good to<br /><br>strong correlation between endurance and function status (MFM).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Number of revolutions cycled at 1, 2, 3, 4 and 5 minutes on the Dynamic bicycle<br /><br>Test- retest values (number of revolutions) for the A6MCT within two weeks<br /><br>(arms and legs)<br /><br>Responsivitiy of the A6MCT and the correlations with the 6MWT, timed tests and<br /><br>the MFM over one year<br /><br>EMG during the cycling on the Dynamic bicycle (only in patients)<br /><br>Heart rate (beats/min) during the cycling on the Dynamic bicycle<br /><br>Subjective fatigue (OMNI) during the cycling on the Dynamic bicycle<br /><br>Distance (m) walked in 6 minutes<br /><br>Timed up and go tests:<br /><br>*Time (s) to walk or run 10 meters<br /><br>*Time (s) to stand up from the floor<br /><br>*Brooke and Vignos scale<br /><br><br /><br>Gender<br /><br>Age<br /><br>Height<br /><br>Body weight</p><br>