We aim to assess whether aerobic exercise leads to increased cerebral perfusion in patients with vascular cognitive impairment.
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in cerebral perfusion, measured with arterial spin labeling (ASL) - MRI
Secondary outcome
Change in cognitive functions on neuropsychological testing;
Change in cardiac function and structure (measured with parameters on cardiac
MRI);
Change in brain structure (measured with parameters on brain MRI);
Change in physical fitness;
Change in blood biomarkers;
Change in neuropsychiatric measures and quality of life;
Change in cerebral autoregulation and cerebral vasomotor reactivity;
Background summary
Over the last 40 years, the relationship between physical activity and
cognitive functioning has been studied in cross-sectional, prospective and
longitudinal studies. These studies show a positive relationship between
physical activity and cognitive functioning. Randomized controlled trials
(RCTs) show that aerobic exercise improves cognitive functioning, in particular
executive functioning, in healthy elderly. Research in patients with cognitive
disorders and dementia show mixed results, possibly by methodological problems.
Vascular cognitive impairment (VCI) is one of the most important causes of
cognitive impairment and dementia. Despite the increasing prevalence of
cerebrovascular disease, few intervention studies focus on non-pharmacological
treatment for this specific group. One promising approach to delay or prevent
the progression of VCI might be aerobic exercise. The biological mechanism
underlying the positive effect of physical activity on cognitive functioning is
poorly understood. Understanding the mechanism is essential to support the use
of physical activity as preventive therapy. Available data have lead to the
hypothesis that the possible beneficial effect of aerobic exercise on cognition
is explained by an improved CBF, which might be mediated by an improved cardiac
output.
Study objective
We aim to assess whether aerobic exercise leads to increased cerebral perfusion
in patients with vascular cognitive impairment.
Study design
Multi-center single-blind randomized controlled trial.
All participants will undergo the same standardized set of clinical,
neuropsychiatric, physical fitness and imaging tests to assess cognitive
functioning, daily functioning, presence of neuropsychiatric symptoms and the
structural and functional brain and cardiac status. After baseline measurement,
participants in the intervention-group will receive an aerobic exercise
program, while the control group doesn't. After 14 weeks the same standardized
set of tests will be repeated.
Participants will be invited to participate in a sub study to assess the effect
of aerobic exercise on cerebral auto regulation and cerebral vasomotor
reactivity.
Intervention
Participants are randomized into an aerobic exercise program or into a control
condition. The aerobic exercise program aims to improve cardiorespiratory
fitness. The program takes 14 weeks in total, with a frequency of 3 times a
week (42 sessions in total). Participants are provided with a bicycle ergometer
at home. Each session consists of an interval training, based on the peak heart
rate. Of the 42 exercise sessions, 13 sessions are supervised by an student
physical therapy. Supervised sessions are frequent in the beginning of the
intervention program and become less frequent during the course of the program.
Participants in the control condition receive two information meetings during
which information about VCI is provided, in addition to usual care.
Study burden and risks
All research data are collected through standard medical procedures and no
experimental intervention is conducted. The additional risk of this study is
considered negligible. The burden of participation consists of time investment
at both baseline and follow-up measurements (approximately 6 hours per
measurement). Participants in the intervention-group will also invest time in
their aerobic exercise program (approximately 42 hours). However, this study
will contribute to knowledge of the effect of physical activity on cerebral
perfusion.
De Boelelaan 1118
Amsterdam 1081 HV
NL
De Boelelaan 1118
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients with vasculair cognitive impairment, age: 50-80yr, cognitive
complaints, independency in daily life, clinical dementia rating <= 0 / 0,5;
MMSE >22, presence of a primary caregiver
Exclusion criteria
Diagnosis of dementia; contra-indication for MRI; major neurological /
psychiatric / cardiac or other medical disease that affects cognition and
mobility
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51973.029.15 |
| OMON | NL-OMON22385 |