The main objective of the study is to investigate the effects of three different passive exercise interventions (Therapeutic Motion Simulation (TMS), Whole Body Vibration (WBV) and a combination of TMS and WBV) on quality of life and physical daily…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the improvement or reduction in decline of quality
of life and physical functioning.
Secondary outcome
Secondary outcomes are cognitive functioning, need for care, care burden and
balance.
Background summary
Physical exercise is beneficial for quality of life and cognitive and physical
functioning of people with dementia. In addition, cognitive functions can be
positively influenced by means of physical exercise. However, physical exercise
is not always feasible due to physical impairments or lack of supervision. This
study aims to proof that an alternative for active exercise in the form of
passive exercise in an multisensory environment is effective to influence
quality of life and physical and cognitive functioning of people with
dementia.
Study objective
The main objective of the study is to investigate the effects of three
different passive exercise interventions (Therapeutic Motion Simulation (TMS),
Whole Body Vibration (WBV) and a combination of TMS and WBV) on quality of life
and physical daily functioning of people with dementia. The secondary objective
is to investigate the effects of the three passive exercise interventions on
cognitive functioning, need for care, care burden and balance.
Study design
The study design is a single-blind randomized controlled intervention study.
Intervention
In all three interventions a robotized exercise platform with chair (and
television screen) is used. During TMS the platform moves congruently with a
movie on the screen. During WBV the platform vibrates with 30Hz. All three
interventions have a duration of 6 weeks and a frequency of 4 times per week.
Group 1 receives TMS during 10 minutes per session, group 2 WBV during 4
minutes per session, group 3 a combination of TMS and WBV during 10 minutes per
session and the control groups receives normal care.
Study burden and risks
The interventions will be performed in the living environment of the
participants. The visits are of short duration (interventions of 4-10 minutes
per session), but the number of visits is considerably (27 visits including
intervention and measurements). The interventions are generally experienced as
pleasant and not as uncomfortable or tiring. For the participants with
dementia, the measurements include a questionnaire, neuropsychological tests
with tasks in which the participant has to respond to questions and three short
balance tests. The interventions are therapeutic and safe . All sessions,
interventions and measurements, are guided individually. Therefore, there are
no risks associated with participation other than the normal risks of daily
life. The experimental groups might benefit from the intervention by
enhancement of quality of life and physical and cognitive functioning. For the
control group no benefits are expected, but they may value the attention
related to the measurements.
A. Deusinglaan 1
Groningen 9713AV
NL
A. Deusinglaan 1
Groningen 9713AV
NL
Listed location countries
Age
Inclusion criteria
Diagnoses of dementia
Age 65 years or older
Low level of physical activity (no activity of minimally moderate intensity (>3METs) during 10 minutes continuously per day)
Exclusion criteria
Serious auditory disorders
Colour blindness
Excessive alcohol- or drug use
Serious progressive or terminal disease
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 | NL58022.042.16 |