The aim of this pilot study is to assess the effect of low intensity mastication training in patients with a mitochondrial disease on masticatory performance, efficacy, endurance, bite force and the feasibility of this training .
ID
Source
Brief title
Condition
- Metabolic and nutritional disorders congenital
- Inborn errors of metabolism
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1.Performance, using Mixing Ability Test: Mixing Index is derived.
2.Efficacy, using Test of Mastication and Swallowing Solids (TOMASS): Z-scores
are calculated (table1) for total bites, total masticatory cycles, total
swallows and total time.
3.Endurance, using the 6 Minutes Mastication Test (6MMT): Number of chewing
cycles per minute and total number of chewing cycles are measured. The
percentage difference between minute 1 and minute 6 is computed A numeric
visual analogue scale (0-10) assess masticatory muscle pain and fatigue
directly after the test and after 5 minutes.
4. Bite force, using VU University Bite Force gauge (VU-BFG): Maximum bite
force is measured taking the highest score in Newton.
Secondary outcome
Secondary parameters are outcomes of the Mandibulaire functiebeperking
vragenlijst (F1.1), and answers of the participants on the feasibility
questionnaire (F1.2).
Background summary
Patients with mitochondrial diseases often complain about fatigue, muscle pain,
loss of muscle strength and diminished endurance in physical activities. Easily
fatigued muscles during mastication is a frequently reported clinical symptom
in patients with mitochondrial disease
Current usual care of these complaints during mastication is the adaption of
food.
Although current usual care is based on compensatory strategies, aerobic
training (cycling, during 8 weeks)) was found to have meaningful effects in
skeletal muscle endurance in patients with a mitochondrial disease (mutation
3243 A * G), with no adverse effects of the training. Furthermore, a study on
efficacy of low intensity mastication training using chewing gum was performed
in patients with Duchenne muscular dystrophy, which showed improvement of the
masticatory performance after a 4 week training (30 minutes, 3 times a day, 5
days a week).
Study objective
The aim of this pilot study is to assess the effect of low intensity
mastication training in patients with a mitochondrial disease on masticatory
performance, efficacy, endurance, bite force and the feasibility of this
training .
Study design
Ten participants with mitochondrial disease will be asked to participate in the
low intensity mastication training during 8 weeks.
A comparison group of ten adult participants with mitochondrial diseases (age
and sex matched to the adults in the intervention group) will serve as control
group.
Intervention
The intervention will consist of an 8 weeks low intensity mastication training
using sugar free chewing gum. The instructions for training are 1 piece of
sugar free chewing gum per exercise, 3 exercises a day of each 20 minutes, 5
days a week. Participants are free to choose the time of training, with an
interval of at least 4 hours between the two exercises.
Participants are asked to keep a diary (f2) to check for compliance and
potential complications.
Participants in the control group will be asked to do nothing additional to
their daily routine. They are supposed to continue using the compensatory
strategies (if applicable) they have already learned.
Study burden and risks
- Time investment: two times 20-30 minutes, at the start and end of the study;
- When assigned to the intervention group: 20 minutes, 3 times a day, 5 days a
week, during 8 weeks chewing on a sugar free chewing gum. This burden is in
proportion because it is a low intensity training and the participant is free
to choose the time of training, thereby fitting in his daily routine. Besides a
two days rest period per week is included to increase compliance;
- It is possible to experience more fatigued muscles during mastication.
- It is possible to experience lack of energy caused by the intervention.
During training, there is an increased energy demand, which theoretically could
increase the oxidative stress. However, this was not found in studies with
endurance training in patients with a mitochondrial disease.
In conclusion the mastication training used in this study has an acceptable,
low overall risk.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Genetically confirmed mitochondrial disease and aged >18.
Exclusion criteria
- Not able to participate on the measurements at baseline, due to physical problems.
- Problems with oral intake, defined as a Functional Oral Intake Scale (FOIS), score 1 * 4 (see Appendix 1 in Protocol) (Crary, 2005)
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 | NL64078.091.17 |