Exergaming Revolution in Dementia (GameDementia)

October 7, 2024 updated by: Eling de Bruin, Eastern Switzerland University of Applied Sciences

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 and/or 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 people's 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 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).

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Zurich
      • Wetzikon, Zurich, Switzerland, 8620
        • Recruiting
        • Sonnweid AG
        • Contact:
          • Markus Baumgartner, PD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neurocognitive disorder based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to the criteria of the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)
  • Mini-Mental-Status-Examination (MMSE) Score of ≥5 and ≤26 out of e maximum of 30

Exclusion Criteria:

  • MMSE <5
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exergaming
Individual active dance game training on Dividat Senso
Other: 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.
Other: Usual Care
Customised care and support as required
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery
Time Frame: Baseline
The SPPB is developed by the National Institute of Aging (NIA). It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (> 65 years of age). The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardised procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
Baseline
Short Phyiscal Performance Battery
Time Frame: after 12 weeks
The SPPB is developed by the National Institute of Aging (NIA). It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (> 65 years of age). The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardised procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: Baseline, after 12 weeks
The MoCA is a objective instrument, which is designed for milder forms of major neurocognitive disorders, contains 12 items to assess seven cognitive domains: memory, language, executive functions, visuospatial skills, attention, concentration, abstraction, calculation, and orientation. The maximal total score is 30 and higher total score indicate less cognitive impairment. A cut-off score of 26 signifies mild cognitive impairment.
Baseline, after 12 weeks
Neuropsychiatric Inventory Questionnaire
Time Frame: Baseline, after 12 weeks
The NPI-Q assesses psychopathological problems and is designed to be a self-administered questionnaire completed by caregivers. The questionnaire screening symptom severity and caregiver distress of the following 12 domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviour, night-time behaviour disturbance, and appetite and eating abnormalities. The symptom severity scale ranging from 1 to 3. The caregiver distress scale ranging from 0 to 5. The NPI total score is calculated by multiplying the frequency and severity rates per domain and adding them up. The total score ranges from 0 to 144, with higher score indicating hight severity and higher distress.
Baseline, after 12 weeks
Cornell Scale for Depression in Dementia
Time Frame: Baseline, after 12 weeks
The observation based CSDD, in the form of an interview with the caregiver assesses symptoms of depression. The CSDD consists of 19 items and each one is scored on a 3-point scale ranging from 0 to 2. Items are clustered into five categories: mood, behavioural disturbance, physical signs, cyclic functions, and ideational disturbance. The maximum score is 38, and higher score indicating more depressive symptoms.
Baseline, after 12 weeks
Quality of Life in Alzheimer's
Time Frame: Baseline, after 12 weeks
The QOL-AD is a brief, 13-item which assesses individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. It is designed to acquire a rating of the patient's Quality of Life from both the patient and the caregiver. It uses simple and straightforward language and responses and includes assessments of the caregivers complete the measure as a questionnaire about their patients' QOL, while patients complete it in interview format about their own QOL. The 13 items are rated on a four-point Likert scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52. The sum of all items; patient and caregiver reports can be evaluated separately and/or combined into a single score if desired.
Baseline, after 12 weeks
Katz ADL
Time Frame: Baseline, after 12 weeks
The interviewer-administered Katz ADL Index assesses participants' function in terms of level of independence or dependence when performing certain daily living activities. It consists of six items: bathing, dressing, transfers, toileting, continence, and feeding. Each item is scored 0 (dependence) or 1 (independence) with a maximum score of 6, which indicates more independence.
Baseline, after 12 weeks
Geriatric Sleep Questionnaire
Time Frame: Baseline, after 12 weeks
Self-reported Questionnaire assesses overall sleep quality. Item score are summed up with the maximal total score of 30. Higher score indicate poorer sleep quality.
Baseline, after 12 weeks
Numbers of falls in the last 12 weeks
Time Frame: Baseline, after 12 weeks
Numbers of Falls during 12 weeks prior to baseline and during the 12 weeks to follow up according to the patient's medical record will be assessed.
Baseline, after 12 weeks
Motion Sensor GENEactiv
Time Frame: Basline, after 12 weeks
GENEActiv is a lightweight and waterproof medical device that delivers continuous recording of high-resolution acceleration that allows a person's daily activities to be classified, second by second, in terms of the time spent lying, sitting, standing, stepping and sleep parameters such as total sleep time, sleep efficiency and body temperature (e.g., circadian rhythm).
Basline, after 12 weeks
Contactless Sensorbox Sleepiz
Time Frame: Baseline, after 12 weeks
Radar-based contactless technology measuring body position and respiratory rate.
Baseline, after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Switzerland University of Applied Sciences

Investigators

  • Principal Investigator: Eling de Bruin, Prof. Dr., Eastern Swiss University of Applied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-00113.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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