Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631742
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Exergaming Revolution in Dementia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of an Exergaming Intervention on Physical Activity and Sleep in People With Major Neurocognitive Disorders Living in Long-term Care Facilities a Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GameDementia
Brief Summary:
This pilot randomized controlled trial evaluates the effect of a 12 weeks exergaming training in people with major neurocognitive disorders MNCD living in long-term care facilities
Detailed Description:
Background Major neurocogntivie disorders MNCD are categorised as public health priority by the World Health Organisation To date there are no disease-modifying treatments that can cure MNCD or effectively halt its progression However lifestyle changes that increase physical activity andor reduce vascular risk factors are effective in protecting against brain atrophy and cognitive decline Therefore it has been suggested to focus on non-pharmacological therapies that target people39s lifestyle such as multimodal treatment strategies that encompass multiple domains including physical exercise and cognitive stimulation Exergames which combine exercise with feedback on performance fun relaxation and socialising are promising for older people
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 Alzheimer39s QoL-AD Katz activities of daily living Katz-ADL Geriatric Sleep Questionnaire GSQ-6 number39s 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 Levenes test and Mauchlys 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 005 two-sided
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 Alzheimer39s QoL-AD Katz activities of daily living Katz-ADL Geriatric Sleep Questionnaire GSQ-6 number39s 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 Levenes test and Mauchlys 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 005 two-sided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None