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Feasibility of a Novel Exergame-Based Training Concept for Older Adults With Mild Neurocognitive Disorder

NCT04996654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-10-12

No results posted yet for this study

Summary

The primary objective of this pilot study is to evaluate the feasibility (i.e. recruitment, adherence, compliance, attrition), usability (i.e. system usability), and acceptance (i.e. enjoyment, training motivation and perceived usefulness) of a newly developed exergame-based intervention concept for older adults with mNCD. As a secondary objective, preliminary effects of the intervention on cognition, brain resting-state functional connectivity, gait, cardiac autonomic regulation, and psychosocial factors (i.e. quality of life, and levels of depression, anxiety, and stress) will be explored. This allows to synthesize data for a sample size calculation on basis of a formal power calculation for a future RCT.

A two-arm, parallel-group, single-blinded (i.e. outcome evaluator of pre- and post-measurements blinded to group allocation) pilot randomized controlled study with an allocation ration of 2 : 1 (i.e. intervention : control) including 17 - 25 older adults with mNCD will be conducted between June and December 2021. The active control group will proceed with usual care as provided by the memory clinics where the patients are recruited. The intervention group will perform a twelve-week training intervention according to a newly developed exergame-based intervention concept in addition to usual care. Primary outcomes will be assessed throughout the training intervention period. The measurements of all secondary outcomes will be conducted at ETH Hönggerberg within two weeks prior to starting (PRE) and after completing (POST) the study intervention.

Conditions

  • Mild Neurocognitive Disorder

Interventions

BEHAVIORAL

Exergame

According to the training concept, each participant is instructed to train 5x/week for 21 min per session resulting in a weekly exercise volume of 105 min. All training sessions are planned to take place at participant's homes using the exergame training system Dividat Senso (Dividat AG, Schindellegi, Switzerland; CE certification).

BEHAVIORAL

Usual Care

An active control group will proceed with usual care as provided by the memory clinics where the patients are recruited.

Sponsors & Collaborators

  • Eling DeBruin

    lead OTHER

Principal Investigators

  • Eling D de Bruin, PhD · ETH Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2022-06-21
Completion
2022-06-21

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04996654 on ClinicalTrials.gov