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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35872

Enrollment

130

Registered

2011-12-29

Start date

2012-04-26

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital neuromusclar disease muscle diseases

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percentage of successful tests (see definition in Chapter 2): feasibility Number of revolutions cycled in 6 minutes on the Dynamic bicycle: good to strong correlation between endurance and function status (MFM).	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results