The primary objective of this study is to evaluate the safety and feasibility of 3 months martial arts based training program for DMD patients. The secondary objective is to gain a first impression on the program*s ability to optimally use one*s…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of our study is the feasibility of the exercise program,
which we consider achieved as the mean adherence rate > 70% of the trainings
sessions and no injuries or adverse effects occur.
Secondary outcome
Secondary outcome measures are: self-perception measured with the CBSK,
strength measured with the hand-held dynamometer, passive range of motion
measured with a goniometer, psychosocial questionnaires, quality of life
questionnaire and functional scales.
Background summary
Duchenne muscular dystrophy (DMD) is a progressive X-linked disorder
characterized by progressive muscle wasting and weakness, resulting in loss of
functional abilities. Functional deterioration leads to loss of independence
and a reduced quality of life. Previous studies have indicated that physical
training programs delay functional deterioration. Nevertheless, the level of
inactivity increases as boys and men with DMD get older. This results in
reduced participation on both physical and social level. Therefore, a training
program aimed at optimally using one*s capacity, slowing down physical
deterioration and improving psychosocial wellbeing, may have great benefits for
boys and men with DMD. We think that a physical and psychosocial training
program, based on martial arts, can have positive effects for boys and men with
DMD.
Study objective
The primary objective of this study is to evaluate the safety and feasibility
of 3 months martial arts based training program for DMD patients. The secondary
objective is to gain a first impression on the program*s ability to optimally
use one*s capacity, slow down physical deterioration and improve psychosocial
wellbeing, and to evaluate participant experiences and compliance, in order to
see if there is a base to conduct the training on a broader scale.
Study design
Explorative feasibility study
Intervention
a 3 month martial arts based training program for DMD patients.
Study burden and risks
The risks associated with participation are negligible. The burden of
participation is low, as the intervention consists of a 1.5 hour weekly
training session, which is comparable to regular sport participation. Expected
benefits are improved physical and psychosocial health.
Reinier postlaan 4
Nijmegen 6500 HB
NL
Reinier postlaan 4
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- DNA established diagnosis of DMD
- Able to touch the top of the head with both hands
Exclusion criteria
- Participants younger than 4 years
- Other disabling diseases influencing physical or psychosocial function
- Not being able to follow instructions or moderate to severe cognitive limitations (IQ<70)
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 | NL67757.091.18 |