The primary objective of this project is to contribute to the knowledge of the optimal medical care of DMD patients with regard to the optimal level of physical activity by examining the effects of training primarily upon muscle endurance and/or the…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes for study 1 will be muscle endurance and functional abilities
of the lower and upper extremities, as assessed with bicycle ergometry and the
Motor Function Measure (MFM). The primary outcome for study 2 will be
functional abilities of the upper extremity (reaching, lifting, manipulating),
as assessed with the Action Research Arm Test (ARAT).
Secondary outcome
Secondary outcomes for both studies will be at the level of body functions and
structures (e.g. muscle tissue), activities (e.g. activities in daily life) and
participation (e.g. health related quality of life).
Background summary
"Use it or lose it" is a well known saying and is to some extent also
applicable to boys with Duchenne Muscular Dystrophy (DMD). Boys with DMD have
reduced muscle mass, muscle strength, muscle endurance and, therefore, loss of
functionality. The increasing effort to perform certain activities, fear of
falling and the need of personal aids (like an electric wheelchair) may limit
leg and arm functions as a result of disuse. An important aim in the management
of DMD is to preserve functional abilities as long as possible, since there is
still no curative (pharmaco)therapy. It is hypothesized that, in the case of
disuse, training may help to gain functional abilities or preserve them.
Study objective
The primary objective of this project is to contribute to the knowledge of the
optimal medical care of DMD patients with regard to the optimal level of
physical activity by examining the effects of training primarily upon muscle
endurance and/or the functional abilities of boys in different stages in the
course of DMD.
Study design
The NUD study will consist of two studies: study 1 *Dynamic leg and arm
exercise training for ambulant or recently wheelchair confined boys with DMD*
and study 2 *Functional training with arm support for boys with DMD who have
been wheelchair confined for several years*. Study 1 will be an explorative
(randomized controlled) trial with multiple baseline measurements. Boys will be
randomly assigned to either the intervention group or the control group
(waiting list). Repeated measurements will be done during the first two months,
followed by a six months training intervention period. The control group will
get the same intervention after the waiting period. Study 2 will be a repeated
measures design, starting with a two months period for baseline measurements,
followed by a six months period in which a training intervention is given.
Intervention
The intervention of study 1 will consist of a low-to-moderate intensity dynamic
exercise training. Boys will train their legs and arms with active-passive
cycling equipment. The intervention of study 2 will be a functional training of
the non-dominant arm and hand with arm support.
Study burden and risks
Burden associated with participation will be limited, since measurements are
non-invasive. Most measurements will be done at home and training intensity and
frequency will be relatively low. This low training intensity will also
strongly reduce the risk of muscle damage. In addition, it is expected that the
interventions are beneficial and may help to gain functional abilities or
preserve them for a longer period. If the results are positive, the principles
of this training may be applicable to other neuromuscular disorders.
Reinier Postlaan 4
6525 GG Nijmegen
NL
Reinier Postlaan 4
6525 GG Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Study 1 'Dynamic leg and arm exercise training for ambulant or recently wheelchair confined boys with DMD':
- Boys with a DNA established diagnosis of Duchenne Muscular Dystrophy
- Boys who are at the end of their ambulation phase and experience difficulty in at least one of the following activities: walking at normal speed, climbing stairs at normal speed, raising from the floor
- Boys who are recently wheelchair confined (1-2 years after stop walking) and are able to stand (un)supported (eventually help needed), are able to touch the top of their head with both hands without assistance ;Study 2 'Functional training with arm support for boys with DMD who have been wheelchair confined for several years'
- Boys with a DNA established diagnosis of Duchenne Muscular Dystrophy
- Boys who are a few years wheelchair confined (2-5 years after stop walking)
- Boys who have problems with lifting their arms and reaching, and are unable to touch the top of their head, are able to use their hands for daily activities and experience difficulties in lifting their arms and reaching
Exclusion criteria
Study 1'Dynamic leg and arm exercise training for ambulant or recently wheelchair confined boys with DMD':
- Other disabling diseases influencing mobility
- Boys with a clinical symptomatic cardiomyopathy
- Boys who are wheelchair confined and/or: are unable to stand and/or are unable to touch the top of their head with both hands
- Boys <=5 years old ;Study 2 'Functional training with arm support for boys with DMD who have been wheelchair confined for several years'
- Other disabling diseases influencing mobility
- Boys who are able to stand
- Boys who are unable to use their hands
- Boys >20 years old
- Boys who already use an arm support
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21842.091.08 |