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RECRUITING
NCT07074639
NA

Cognitive-Motor Exergame Training in Frail Adults

Sponsor: Eleftheria Giannouli

View on ClinicalTrials.gov

Summary

This international multicentre pragmatic randomized controlled trial (RCT) aims to evaluate the effectiveness of personalized, home-based cognitive-motor training using exergames in improving cognitive and motor functions in frail adults. A total of 344 frail participants from five European countries will be enrolled. Participants in the intervention group will engage in a personalized exergame program, while the control group will follow the Otago Exercise Program. Both groups will undergo 12 weeks of training. The primary outcome is balance, a critical component of functional independence and fall prevention, and a common denominator affected in both physical and cognitive frailty. Secondary outcomes including cognitive and motor fall-risk factors, fall incidence, cost-effectiveness, and psychosocial outcomes.

Official title: S.M.A.R.T: A Pragmatic Randomised Controlled Trial of Personalized Cognitive-Motor Exergame Training in Frail Community-Dwelling Adults

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2025-06-16

Completion Date

2027-05-31

Last Updated

2025-07-20

Healthy Volunteers

No

Conditions

Interventions

OTHER

Personalized, home-based motor-cognitive exergame training

The simultaneous cognitive-motor training in this study will be delivered using the exergame platform "Senso Flex" by Dividat (Dividat AG, Schindellegi, Switzerland), which is a pressure-sensitive foldable mat that connects to standard televisions (or any big screen). Games will be allocated across three primary domains: cognition (consisting of five sub-domains), balance (consisting of four sub-domains) and endurance. The five sub-domains of cognition are visuospatial orientation (Cognition A), memory (Cognition B), response inhibition (Cognition C), choice reaction time (Cognition D) and task switching (Cognition E). The four sub-domains of balance are mediolateral weight-shifting (Balance A), multidimensional weight-shifting (Balance B), free walking/stepping (Balance C) and mediolateral stepping (Balance D). The training sessions will be personalized in terms of difficulty level.

OTHER

Otago Exercise Program

Participants in the CG will receive the evidence-based OEP on fall prevention. The OEP was selected as an active control to mirror usual care in real-world clinical settings and support the pragmatic nature of our study design. The program will be implemented in the form of a booklet, designed to provide a comprehensive guide for improving balance, strength, and overall physical function. Specifically tailored for older adults, the program includes a variety of exercises targeting key areas such as lower limb strength, balance, and flexibility. It features step-by-step instructions, illustrations, and tips to ensure exercises are performed safely and effectively.

Locations (1)

Institute of Human Movement Sciences and Sport, ETH Zürich

Zurich, Switzerland