This project aims to determine the effects of an extensive exercise program in MCI patients with respect to the progression of the disease
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is cognitive performance, determined by a
neuropsychological test battery.
Secondary outcome
Secondary outcomes are physical fitness, cerebral autoregulation,
cerebrovascular reactivity, prefrontal oxygenation, arterial stiffness,
endothelial function, quality of life, epigenetics and cerebral structure
Background summary
A lack of physical exercise plays a major role in the pathophysiology of
vascular, metabolic, and metastatic diseases. Regular physical exercise has
been successfully proven to counteract this deconditioning. Human and animal
studies have demonstrated that regular physical activity targets brain function
by increasing cognitive reserve. There is also evidence of structural changes
caused by exercise in preventing or delaying the genesis of neurodegeneration.
A considerable number of studies have targeted the effects of physical activity
on functional and structural brain changes in patients at greater risk for
Alzheimer*s disease (AD). Epidemiological studies have shown that leisure-time
physical activity at midlife is associated with a decreased risk of dementia
and AD later in life. Although initial studies indicate enhanced behavioural
performance in dementia patients after three months of exercise, little is
known about the effect of an extensive, controlled and regular exercise regimen
on the progressive neuropathology of patients with MCI.
It is hypothesized that mild cognitive impairment (MCI)-related specific
decreases in cognitive and psychomotor functioning will show less progression
or even be improved after a one-year aerobic exercise intervention as compared
to a group of patients undergoing non-aerobic exercise (gymnastic exercises) as
well as to a control group provided with no intervention.
Study objective
This project aims to determine the effects of an extensive exercise program in
MCI patients with respect to the progression of the disease
Study design
Single blind randomised intervention study with pragmatic approach. The two
training groups are randomized, the contropgroup is not randomised. The
controlgroup consists of participants eligible to participate, but for whom it
is practical not possible to participate, for example due to living too far
away.
Intervention
Patients are classified in 3 groups. One group receives a standardized one-year
extensive aerobic exercise intervention (3 units à 45min / week, according to
WHO recommendations). The second group receives non-aerobic exercise (3 units à
45min / week) and the third group is provided with no intervention.
Study burden and risks
Participants of this study will visit the Radboudumc 7 times in one year,
taking approximately
18 hours in total. Only non-invasive measurements will be performed and all
procedures have been used on healthy MCI patients before and were well
tolerated.
The training sessions of the aerobic and non-aerobic will cost about 150*45
minutes=112 hours. The exercise intervention will be safe for elderly with MCI,
as is piloted before. Only muscle soreness and tiredness may be caused by the
training. The aerobic and non-areobic intervention are expected to be
beneficial for cognition and physical functioning. Also the social part may be
important of the study. By training in groups, people are socially active and
experience the trainings as fun together.
Reinier Postlaan 4
Nijmegen 6500HB
NL
Reinier Postlaan 4
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of Mild cognitive impairment (MCI) (Peterson criteria or practical identification)
Physical ability sufficient to allow performance of endurance exercise training
Exclusion criteria
Diagnosis of dementia/Alzheimer's disease
Engagement in moderate-intensity aerobic exercise training for more than 30 minutes, 3 times per week, during past 2 years
History of brain damage
History of myocardial infarction
Unstable chronical disease
Uncontrolled hypertension
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 | NL54544.091.15 |