Passive exercise for an active brain in dementia|
|- candidate number||26968|
|- NTR Number||NTR6290|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-mrt-2017|
|- Secondary IDs||733050611 ZonMw (deltaplan dementia)|
|- Public Title||Passive exercise for an active brain in dementia|
|- Scientific Title||Passive exercise for an active brain in dementia|
|- hypothesis||The central hypothesis is that TMS and WBV due to their own specific working mechanisms both will lead to an improvement in quality of life, daily functioning and cognitive functioning, but that the combination of TMS and WBV will lead to an stronger cognitive effect. In addition, improvement of daily functioning and improved cognition will lead to a reduction in need for care, because both are strongly related to the independence of older people with dementia.|
|- Healt Condition(s) or Problem(s) studied||Dementia|
|- Inclusion criteria||- Officially diagnoses with dementia|
- 65 years or older
- Low levels of physical activity (no activity of minimally moderate intensity (>3METs) during 10 minutes continuously per day)
|- Exclusion criteria||- Contra-indication for exercise|
- Serious auditory disorders
- Colour blindness
- Excessive alcohol- or drug use
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-nov-2016|
|- planned closingdate||1-jan-2019|
|- Target number of participants||196|
|- Interventions||Therapeutic motion stimulation (TMS). |
TMS uses a platform with a television screen (see Figure 2). On the screen movies are shown from the perspective of a vehicle, for instance, horse or motor riding in a nice environment. Herewith, the platform moves congruently with the movies. This way, the participant on the platform exercises in a passive way. In addition, the participant is stimulated multisensory: visually, auditory and proprioceptive.
Whole body vibration (WBV).
During WBV the same platform is used, but now the platform vibrates with a frequency of 30Hz and an amplitude of 1-2 mm. Such vibrations are very mild and can be safely applied without risks of adverse events, even in frail and cognitively impaired older populations
TMS + WBV
WBV is integrated in the TMS movies. The movies now include parts with the mild 30Hz vibrations, such as sitting on a Harley and waiting for a traffic light, cycling over uneven surfaces or sailing over small waves.
The control group will not receive a placebo intervention but only regular care, since this is prescribed by Deltaplan Dementia.
|- Primary outcome||The primary outcome measures are quality of life (QOL) and daily functioning of people with dementia.|
|- Secondary outcome||secondary outcome measures include cognitive functioning, need of care, family caregiver burden and physical functioning of the participants and their (in)formal caregivers.|
|- Timepoints||Baseline measurement (T0)|
Post measurement (T1)
Follow-up measurement (T2)
QOL will be assessed by questionnaires (EQ-5D-5L,
Qualidem, and TOPICS-MDS)
Daily functioning will also be assessed by questionnaires (Barthel index, and TOPICS-MDS)
Cognitive functioning is assessed by multiple neuropsychological tests (MMSE, alertness, trailmaking test A, Stroop, digit span forward and backward, phonemic and semantic fluency)
Physical functioning is assessed by a couple of physical tests (Timed Up and Go test, FICSIT-4 test, and the 6 meter walking test)
Need for care will be assessed by the TOPICS-MDS.
Careburden will be assessed by multiple questionnaires (TOPICS-MDS, caregiver strain index, zarit burden interview)
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Marelle Heesterbeek|
|- CONTACT for SCIENTIFIC QUERIES|| M.J.G. Heuvelen, van|
|- Sponsor/Initiator ||University of Groningen|
(Source(s) of Monetary or Material Support)
|ZonMw, Vita Motion Technology|
|- Brief summary||Rationale: 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 functioning and cognitive of people with dementia.|
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.
Study population: The study population consists of people diagnosed with dementia, age 65 years or older, Mini Mental State Examination score > 15, and a sedentary lifestyle (defined as no physical activity of at least moderate intensity during at least a block of 10 minutes a day ).
Intervention (if applicable): 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.
Main study parameters/endpoints: The main study parameter is the improvement or reduction in decline of quality of life and physical functioning.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 (26 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.
|- Main changes (audit trail)|
|- RECORD||29-mrt-2017 - 10-jun-2018|
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