Our aim is to investigate the cognitive effects of an interactive cycling training in early stage dementia patients (in comparison to an aerobic cycling training and a control group).In addition we will investigate whether the effects of training…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcome measure is change in executive functioning, before and
after the training intervention, in the interactive cycling group. Executive
function will be measured with neuropsychological tests. Furthermore verbal and
visual-spatial memory will be assessed.
Secondary outcome
Secondary outcome measures are physical functioning measured with
performance-based tests, Brain Derived Neurothropic Factor (BDNF) measured via
blood sample, prefrontal cortex activation measured with functional Near
Infrared Spectroscopy (by fNIRS) and changes in activities of daily living
(ADL), mood and quality of life, as measured by questionnaires
Background summary
There is no cure for dementia. Physical activity could be an alternative to
medications in an effort to slow dementia-related cognitive decline. In healthy
older subjects physical activity leads to improved cognition. In people with
dementia the results are mixed. Recent research shows that exercise in
combination with exposure to cognitive stimuli can lead to improved cognitive
functioning in elderly with cognitive impairment. However further research is
needed. In addition, it is unknown whether effects are moderated by APOEe4
status, the most important biological risk factor for dementie.
Study objective
Our aim is to investigate the cognitive effects of an interactive cycling
training in early stage dementia patients (in comparison to an aerobic cycling
training and a control group).
In addition we will investigate whether the effects of training are modified
by APOEe4 carriers state.
We expect that interactive cycling leads to a greater improvement in executive
functioning compared to an aerobic bicycle training. We expect stronger
effects in APOEe4 carriers than in non-carriers.
Study design
The design is a single blinded RCT.
Intervention
The interactive cycling training consists of cycling on a home-trainer. During
the cycling participants follow the route on a screen and have to conduct
simple cognitive tasks. Participants will train 3 times a week for 12 weeks
and are instructed to gradually increase their exercise frequency to 45 minutes
per session. The aerobic cycling training consists of cycling on a stationary
bike. Participants will also train 3 times a week for 12 weeks and are
instructed to gradually increase their exercise frequency to 45 minutes per
session. The intervention in the control group consists of flexibility
exercises with the same duration and frequency.
Study burden and risks
The burden consists of participation in the intervention (27 hours) and
measurements (approximately 5.5 hours) over a period of 24 weeks.
The in- and exclusion criteria are strict, e.g. no severe pulmonary or
cardiovascular disease, to minimize the risk for the participant and avoid the
presence of adverse events. Also, the interventions are supervised by well
trained master students on a one-to-one basis, directly supervised by the
physician-researcher, thereby increasing patient safety. With these strict
measures we expect that there will be no extra risk involved in participation
in the study. . For some of the participants in the cycling or interactive
cycling group, especially those who were not practicing any kind of physical
exercise prior to the study, there is a slight possibility that they might feel
some muscle soreness and fatigue after training. However, the training will be
customized on someone's individual capacities. The training will be performed
at the location the participant prefers.
The tests are feasible and safe for older persons with dementia. If possible,
the tests will be performed at the participants home. However, some tests need
to be performed at the Radboudumc because of available material for testing
(for example, functional Near Infrared Spectroscopy (fNIRS)).
Reinier Postlaan 4
Nijmegen 6500 HB
NL
Reinier Postlaan 4
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of dementia
Mini Mental State Examination (Folstein and Folstein 1975) score > 20
Clinical Dementia Rating (CDR) score 0.5 -1.0, and still capable to give informed consent
Having insufficient physical activity according to the ACSM guideline for older adults (maximum of 30 minutes five days a week moderate intensity)
Exclusion criteria
Wheelchair bound
Use of specifically dementia targeted nutritional supplements (e.g. Souvenaid) within the last 3 months
Cardiovascular problems that limit physical activity
Serious neurological or orthopedic disorder that limit physical activity
Diagnosis of severe depression, bipolar disorder or psychotic disorder (DSM-IV)
Current alcohol or drug abuse (DSM-IV)
Problems with the Dutch language
Severe hearing or visual problems not able to correct with the use of a hearing
device/glasses
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 | NL52581.091.15 |