Exercise testing in ambulatory pediatric patients with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy: a pilot study

Exercise testing in ambulatory pediatric patients with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy: a pilot study - Exercise testing in Muscular Dystrophy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35527

Enrollment

Registered

2012-01-23

Start date

2012-02-01

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

muscle disease Muscular dystrophy

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Genetically confirmed diagnosis of DMD or BMD Ability to follow instructions regarding testing Parental and child informed consent 6-20 years of age Ability to walk >= 20 meter without assistive devices

Exclusion criteria

Exclusion criteria: Concomitant medical problems that might intervene with the outcomes of the testing Previous episodes of rhabdomyolysis Reduced cardiac function that does not allow cardio pulmonary maximal exercise testing (according to pediatric cardiologist)

Design outcomes

Primary

Measure	Time frame
Feasibility: Feasibility outcome parameters include measurement completion, acceptability and adverse events: Measurement completion: Measurement completion rate is defined as the number of participants able to complete the exercise test. A premature determined exercise test can be caused by insufficient motivation and/or understanding of the test protocol. In this study, measurement completion for the 6MWT is defined as a test performance according ATS guidelines (27). Measurement completion of the CPET is defined as a test according Rowlands criteria on physiological responses (table 1) or a minimal test durance of six minutes. Rowlands criteria are subdivided in subjective and objective criteria, where every child has to meet the first and at least one of the latter. A minimal accepted measurement completion rate for both tests is set at 90%. Acceptability: The willingness to perform the test again in the future based on experienced burden will be assessed with a Visual Analoge Scaleafter each exercise test. A higher score expresses less willingness to perform the test again in the future. During the 6MWT the fall frequency, duration from fall to fall recovery and number and duration of resting periods will be measured. Adverse events: Adverse events following exercise testing will be monitored: Physical complaints will both be evaluated with a Visual Analoge Scale before and after the exercise test and every morning and evening in the seven consecutive days following the exercise test. Two day days after each exercise test a semi-structured interview will be conducted by telephone with each participant and his parents. Clinical features of muscle damage will be checked and reported (appendix 1) (28,29). (Research protocol page 15-16)	—

Measure

Time frame

Feasibility: Feasibility outcome parameters include measurement completion, acceptability and adverse events: Measurement completion: Measurement completion rate is defined as the number of participants able to complete the exercise test. A premature determined exercise test can be caused by insufficient motivation and/or understanding of the test protocol. In this study, measurement completion for the 6MWT is defined as a test performance according ATS guidelines (27). Measurement completion of the CPET is defined as a test according Rowland*s criteria on physiological responses (table 1) or a minimal test durance of six minutes. Rowland*s criteria are subdivided in subjective and objective criteria, where every child has to meet the first and at least one of the latter. A minimal accepted measurement completion rate for both tests is set at 90%. Acceptability: The willingness to perform the test again in the future based on experienced burden will be assessed with a *Visual Analoge Scale*after each exercise test. A higher score expresses less willingness to perform the test again in the future. During the 6MWT the fall frequency, duration from fall to fall recovery and number and duration of resting periods will be measured. Adverse events: Adverse events following exercise testing will be monitored: Physical complaints will both be evaluated with a *Visual Analoge Scale* before and after the exercise test and every morning and evening in the seven consecutive days following the exercise test. Two day days after each exercise test a semi-structured interview will be conducted by telephone with each participant and his parents. Clinical features of muscle damage will be checked and reported (appendix 1) (28,29). (Research protocol page 15-16)

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Countries

Netherlands

Outcome results