Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2024-09-27
2027-04-30
Brief Summary
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Detailed Description
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The goal of this pilot randomized controlled trial is to evaluate the effect of an exergaming intervention in people with MNCD. The main questions it aims to answer are:
* How does an exergaming intervention effects gait speed, cognitive and motor functions as well as depressive symptoms and quality of life in residents of a long-term care facilities.
* How does an exergaming intervention effects physical activity and sleep in residents of a long-term care facilities.
Methods: Investigators plan to include 48 participants living in long-term care facilities. Participants will participate in a 12 weeks active dance video game (3x 15minute per week) or will get care as usual. The Short Physical Perfomance Battery (SPPB), The Montréal Cognitive Assessment (MoCA), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Quality of Life in Alzheimer\'s (QoL-AD), Katz activities of daily living (Katz-ADL), Geriatric Sleep Questionnaire (GSQ-6), number\'s of falls in the last 12 weeks, physical activity and sleep parameters of the motions sensor GENEactiv and sleep parameters of the contacless sensorbox Sleepiz are measured at baseline and post intervention.
For all outcomes, descriptive statistics will be computed first. Normality distribution of data will be checked using the Shapiro-Wilk test and Q-Q-plots. The assumptions of homogeneity of variance and of sphericity will be checked using Levene's test and Mauchly's test, respectively. In case all assumptions are met, a two-way analysis of covariance (ANCOVA) will be computed for all primary and secondary outcomes with the pre-test as covariate for the predicting group factor and the posttest as outcome variable. Therefore, the outcome is the differences of the pre- and post-test with the baseline as the influencing variable. In case not all assumptions for ANCOVA are met, Quade non-parametric tests will be used. The level of significance will be set to p ≤ 0.05 (two-sided).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Exergaming
Individual active dance game training on Dividat Senso
Exergaming on Dividat Senso
The active dance video game is played with the Dividat Senso (Dividat \| Senso: cognitive-motor training). It consists of a dance disc with four arrows (up, down, left, right), and the game is played on a large screen (which is connected to the PC). The screen indicates which arrow the person should step on, thus controlling the game through body movements. The games give the person feedback in the form of auditory, visual, and somatosensory stimuli.
Usual Care
Customised care and support as required
Usual Care
Standardised care with meal service, individual activities (e.g. hiking group, walking group, exercise group, handicrafts, gardening group, singing, painting or lunch) and customized care and support as required.
Interventions
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Exergaming on Dividat Senso
The active dance video game is played with the Dividat Senso (Dividat \| Senso: cognitive-motor training). It consists of a dance disc with four arrows (up, down, left, right), and the game is played on a large screen (which is connected to the PC). The screen indicates which arrow the person should step on, thus controlling the game through body movements. The games give the person feedback in the form of auditory, visual, and somatosensory stimuli.
Usual Care
Standardised care with meal service, individual activities (e.g. hiking group, walking group, exercise group, handicrafts, gardening group, singing, painting or lunch) and customized care and support as required.
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental-Status-Examination (MMSE) Score of ≥5 and ≤26 out of e maximum of 30
Exclusion Criteria
* Unstable cardiovascular condition or other medical condition that does not allow for safe participation according to the recommendations of the American College of Sports Medicine
* Planned transfer to another facility within the next 3 months
* Acute behavioural problems
ALL
No
Sponsors
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Eastern Switzerland University of Applied Sciences
OTHER
Responsible Party
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Eling de Bruin
Prof. Dr. Eling de Bruin
Principal Investigators
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Eling de Bruin, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Eastern Swiss University of Applied Sciences
Locations
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Sonnweid AG
Wetzikon, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Markus Baumgartner, PD
Role: primary
References
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Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Bellettiere J, Lamonte MJ, Unkart J, Liles S, Laddu-Patel D, Manson JE, Banack H, Seguin-Fowler R, Chavez P, Tinker LF, Wallace RB, LaCroix AZ. Short Physical Performance Battery and Incident Cardiovascular Events Among Older Women. J Am Heart Assoc. 2020 Jul 21;9(14):e016845. doi: 10.1161/JAHA.120.016845. Epub 2020 Jul 14.
Cassidy B, Arena S. The Short Physical Performance Battery as a Predictor of Functional Decline. Home Healthc Now. 2022 May-Jun 01;40(3):168-169. doi: 10.1097/NHH.0000000000001070. No abstract available.
Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
Lindbergh CA, Dishman RK, Miller LS. Functional Disability in Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2016 Jun;26(2):129-59. doi: 10.1007/s11065-016-9321-5. Epub 2016 Jul 8.
Sanford AM. Mild Cognitive Impairment. Clin Geriatr Med. 2017 Aug;33(3):325-337. doi: 10.1016/j.cger.2017.02.005. Epub 2017 May 17.
Tisher A, Salardini A. A Comprehensive Update on Treatment of Dementia. Semin Neurol. 2019 Apr;39(2):167-178. doi: 10.1055/s-0039-1683408. Epub 2019 Mar 29.
Erickson KI, Raji CA, Lopez OL, Becker JT, Rosano C, Newman AB, Gach HM, Thompson PM, Ho AJ, Kuller LH. Physical activity predicts gray matter volume in late adulthood: the Cardiovascular Health Study. Neurology. 2010 Oct 19;75(16):1415-22. doi: 10.1212/WNL.0b013e3181f88359. Epub 2010 Oct 13.
Guure CB, Ibrahim NA, Adam MB, Said SM. Impact of Physical Activity on Cognitive Decline, Dementia, and Its Subtypes: Meta-Analysis of Prospective Studies. Biomed Res Int. 2017;2017:9016924. doi: 10.1155/2017/9016924. Epub 2017 Feb 7.
Vancampfort D, Solmi M, Firth J, Vandenbulcke M, Stubbs B. The Impact of Pharmacologic and Nonpharmacologic Interventions to Improve Physical Health Outcomes in People With Dementia: A Meta-Review of Meta-Analyses of Randomized Controlled Trials. J Am Med Dir Assoc. 2020 Oct;21(10):1410-1414.e2. doi: 10.1016/j.jamda.2020.01.010. Epub 2020 Feb 19.
Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252.
Dimitrov DM, Rumrill PD Jr. Pretest-posttest designs and measurement of change. Work. 2003;20(2):159-65.
Other Identifiers
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2024-00113.
Identifier Type: -
Identifier Source: org_study_id
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