This study exists of two parts:Cross-sectional study: what are the precise characteristics of physical functioning in EOD patients in comparison to a control group? Not all EOD patients show apathy and physical inactivity. It will be examined…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters in the cross-sectional study will be measures
concerning physical functioning (question 1a) and measures concerning global
cognitive functioning, mental speed, and executive functioning (question 1b).
Primary study parameters in the intervention study will be measures concering
global cognitive functioning, mental speed, instrumental activities of daily
living, and quality of live.
Secondary outcome
Secundary measures concern mood and rest-activity rhythm.
Background summary
Development of early-onset dementia (EOD) is very radical and disabling for
both patient and family, due to the still prominent role of the patient in
society. Except for knowledge on cognitive disorders not much is known about
other disabling disorders in EOD. Several characteristics of EOD, like apathy
and loss of initiative, could lead to motor inactivity, which can lead to motor
disability. Strong evidence is found on a strong association between physical
aerobe activity and cognition in people of both middle age as in the elderly.
Study objective
This study exists of two parts:
Cross-sectional study: what are the precise characteristics of physical
functioning in EOD patients in comparison to a control group? Not all EOD
patients show apathy and physical inactivity. It will be examined whether
cognitive differerences are present between EOD patients who are physically
active and EOD patients who are not.
Intervention study: Is an aerobe activity program able to slow down the
progressive nature (concerning cognition (especially executive functioning),
mood, and rest-activity rhythm in EOD patients who participate in such a
program in comparison to EOD patients who participate in a flexibility program
(which is non-aeroob)? Is an aeroob activity program able to slow down the
progressive nature to a higher extent when the program is directly guided in
contrast to when the program is indirectly guided?
Study design
Centre randomised intervention study.
Intervention
Participants with EOD who participate in the intervention part of this study
will be randomised into a 3 month enduring program: Directly Guided Aerobe
Activity Program (aerobe activity, such as running, 3 times al week, 60
minutes); Directly Guided Flexibility Program (flexibility training and
relaxation exercises); Indirectly Guided Aerobe Activity Program (*therapy*,
stimulation of aerobe activity at home).
Study burden and risks
The risks are minimal, during the intervention there will be guarded against
falling. Patients could be burdened by the neuropsychological and motor
assessment, which can be tiring.
Van der Boechorststraat 1
1081 BT Amsterdam
NL
Van der Boechorststraat 1
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Main study:
- Diagnosis of early-onset dementia (onset of complaints < 66 years) (among others Alzheimer's disease, Vascular dementia, Frontotemporal dementia).
- Relatively early stage of dementia (MMSE * 16)
- Primary caregiver available;Extension:
- Diagnosis of (pre)senile dementia, or presence of similar symptoms due to a different
condition.
- Participant has to be able to walk, or when the participant is bound to a wheelchair he has to be physically active.
- Gradual progression of cognitive disorders
Exclusion criteria
Main study:
- Bound to a wheelchair
- Neurodegenerative diseases at which motor symptoms are the primary problems, such as M. Parkinson and M. Huntington.
- Cardiovascular problems, such as severe cardiac problems or severe hypertension.
- Abuse of alcohol or other substances
- Trauma capitis in the medical history, at which a loss of consiousness was present of more than 15 minutes
- Extended history of psychiatry (major depression , bipolar disroder, psychosis)
- Severe visual problems
- Severe auditive problems
- Insufficient mastery of the Dutch language;Extension: same exclusion criteria
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 | NL27426.029.09 |