The objective is to investigate the effects of a combined strength and aerobic exercise program on cognition, physical functioning, social functioning and ADL.
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the differences between cognition (memory and
executive functioning) between pre-, post-, and delayed post measurement.
Secondary outcome
The secondary study parameters are the differences between physical test
performances, ADL questionnaires and affective functioning questionnaires
between pre-, post-, and delayed post measurement.
Background summary
Dementia presents a major public health problem that impacts people*s ability
to maintain cognitive, physical and social function. There are indications that
physical activity can enhance cognition in older people with dementia. However,
the number of studies is limited, the outcomes ambiguous and only studies with
aerobic exercise programs were performed. This study focuses on the effects of
combined strength and aerobic exercise in older people with dementia to
evaluate the theory that there are stronger effects on cognition, physical
functioning, ADL and social funtioning in comparison with an aerobic exercise
program and controls who recieve social visits.
Study objective
The objective is to investigate the effects of a combined strength and aerobic
exercise program on cognition, physical functioning, social functioning and
ADL.
Study design
The study design is a randomized clinical trial. After pre-stratification on
MMSE score, the participants will be randomized over three groups: combined
strength and aerobic exercise, aerobic exercise only, control intervention
(social visits). Measurements will take place, blinded for group, before the
intervention (pretest), after the 10 weeks intervention (posttest) and at
follow-up 10 weeks after the posttest.
Intervention
The intervention consists of a supervised physical exercise program which will
be offered for 30 minutes a day, five days a week, during 10 weeks. The
combined strength and aerobic group walk on 3 days per week and perform
strength training on 2 days per week. The aerobic group will walk on 5 days per
week. The controls receive social visits with the same frequency and duration.
Study burden and risks
Burden for the participants are the exercise program, as well as the physical
test battery and neuropsychological test battery which are performed three
times with 10 weeks in between. The total test battery takes approximately 65
minutes per session for each participant and 20 minutes for healthcare
personnel. Exercises and tests are safe and feasible in frail older people with
dementia. All activities in this study are within the range of normal
activities of daily life. Participants are provided with individual
supervision. Therefore, the risks involved in this study are even less than the
normal risks of daily life. All groups receive the same amount of social
interaction. Supervised activities that are performed in physical active groups
are the same as in activities of daily live.
Antonius Deusinglaan 1
9713AV Groningen
NL
Antonius Deusinglaan 1
9713AV Groningen
NL
Listed location countries
Age
Inclusion criteria
The patient will be included if he/she is diagnosed with dementia, is mobile with or without using an assistive walking device and has a Mini Mental State Examination (MMSE) score between 10 and 22 (range MMSE = 0-30) (n=153). In addition, 30 participants with MCI/mild dementia and a MMSE score between 23-27 will be included.
Exclusion criteria
Participants are excluded if the patient has a MMSE score < 10 or > 22, are not able to perform the Timed Up & Go Test, are wheelchair bound, have cardiovascular problems (e.a. severe high blood pressure or cardiac problems), have problems with the Dutch language, have a history of alcoholism, have severe visual problems, have severe auditive problems.
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 | NL32037.042.10 |
| OMON | NL-OMON22579 |