Part 1: Main objective: Investigate the relation between level of physical (in)activity and cognition in healthy elderly and to examine the possible moderating effects of (Apolipoprotein E e4) APOEe4 status and IGF-1 and BDNF levels and blood…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main outcome measure is cognitive function, measured with neuropsychological
tests.
Secondary outcome
Secondary outcome measures are physical functioning measured with
performance-based field tests, IGF-1 and BDNF serum levels, blood metabolite
concentrations and ADLS, mood and quality of life, measured by questionnaire.
Background summary
To delay or possibly offset cognitive decline increasing emphasis has been
placed on the development of preventive strategies and identification of risk
factors. The present study focusses on two well established risk factors for
developing cognitive decline and Alzheimer dementia; genetic susceptibility
and physical inactivity in healthy elderly. An important population of people
at increased risk for developing dementia is carriers of the APOEe4 allele.
Apolipoprotein E (APOE) is a cholesterol carrier that supports lipid transport
and brain injury repair and is the strongest genetic risk factor for AD.
Individuals carrying the e4 allele (14% of the population) have an increased
risk of developing AD with younger age at onset.
Besides genetic susceptibility lifestyle appears to play a modifying role in
the development of cognitive decline and dementia. Physical activity offsets
the cognitive decline that occurs in late adulthood and diminishes the
likelihood of developing dementia. APOEe4 carriers might be prone to physical
inactivity. For this group increasing physical activity could offer protection
against (future) cognitive decline.
Study objective
Part 1: Main objective: Investigate the relation between level of physical
(in)activity and cognition in healthy elderly and to examine the possible
moderating effects of (Apolipoprotein E e4) APOEe4 status and IGF-1 and BDNF
levels and blood metabolite concentrations.
Part 2: Investigate the effects of an increase in physical activity generated
by a lifestyle intervention in (inactive) APOEe4 carriers and non-carriers on
physical activity level, physical fitness and cognition and to examine the
possible moderating role of APOEe4 status and BDNF and IGF-1 levels and blood
metabolite concentrations.
Study design
The design of study 1A is a cross sectional study. Study 1B is a single blind
Randomized Controlled Trial.
Intervention
In part 2 of the study the participants in the experimental group participate
in the COACH program, a lifestyle training developed to increase daily physical
activity. The COACH method consists of 7 individual coaching session directed
at counselling the participants in reaching their personal activity goals. The
intervention for the control group consists of individual guidance in the
stretching and toning of the muscles. The sessions are scheduled periodically,
spread over a period of 6 months, plus one follow up session after 3 months.
Participants in the experimental group are required to keep track of their
daily level of physical activity by means of a pedometer.
Study burden and risks
The burden in study 1 consists of keeping track of daily activity by means of
wearing a pedometer for 2 consecutive weeks and participation in assessment of
cognitive (approximately 70 minutes) and daily functioning (approximately 20
minutes) and physical fitness (approximately 37 minutes). The researchers will
contact participants twice by telephone to ask participants about their
experiences with the pedometer. Total 240 minutes. Blood samples to determine
levels of IGF-1 and BDNF and blood metabolite concentrations and saliva samoles
to determine APOEe4 status will be taken once.
The burden in the second part of the study consists of participation in the
intervention (8 coaching session of 45 minutes each = 6h ) and assessment of
cognitive (approximately 70 minutes) and daily functioning (approximately 20
minutes) and physical fitness (approximately 37 minutes) after a period of 6
months and follow up measurement after another 3 months (5 hours):
approximately 10 hours and 30 minutes in total.
Participants in the experimental group will be guided towards a more active
lifestyle which requires a daily increase in activity.
Participants in the experimental group are required to keep track of their
daily level of physical activity by means of a pedometer.
Participants in the control group are required to keep track of their daily
level of physical activity twice for 2 months by means of a pedometer.
Participants in the control group will participate individually guided
stretching and toning sessions (7 x 45 minutes) and one coaching session 45 min
at follow up (6 hour) and in the assessment of cognitive (approximately 70
minutes) and daily functioning (approximately 20 minutes) and physical fitness
(approximately 37 minutes) after a period of 6 months and at follow up
measurement after another 3 months. Approximately 11 hours and 30 minutes in
total. Blood samples to determine IGF-1 and BDNF serum levels will be taken at
the end of the intervention and at follow up assessment. All activities in this
study are self-chosen and lie within the range of normal activities of daily
life. Participants are guided individually in finding suitable ways of
improving their daily physical activity level.
Van der Boechorststraat 7-9
Amsterdam 1081
NL
Van der Boechorststraat 7-9
Amsterdam 1081
NL
Listed location countries
Age
Inclusion criteria
- Age * 55 years
- Males and females
- Able to perform the Timed Up & Go Test with or without assistive device
- Mini Mental State Examination (Folstein, Folstein, & McHugh, 1975) score higher than 25
- In the second part of the study only those participants who display low levels of physical activity as measured in Part 1 of the study are recruited and included
Exclusion criteria
- Weelchair-bound
- diagnosed with dementia or mild cognitive impairment
- diagnosed with a neurodegenerative disease
- diagnosed with a progressive or terminal disease
- diagnosed with serious cardiovascular disease, such as heart failure that limit physical activity
- epilepsy
- (history of) substance abuse
- (history of) major psychiatric illness (e.g. depression)
- severe visual or auditory problems
- insufficient proficiency of the Dutch language
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 | NL53306.029.15 |