NCT05991011

Brief Summary

While the association of physical and/or motor and/or cognitive components with training can generate synergistic effects and thus create an efficient cognitive enrichment program, very few studies have focused on finding an optimal combined program for older adults. According to the model of Herold and his colleagues, there are two modalities of simultaneous combined training: Thinking While Moving (TwM), when the additional cognitive task is not linked to the motor task, and Moving While Thinking (MwT), when the cognitive task is integrated into the motor task. They assume the latter approach is the most promising for improving cognitive reserve. Nevertheless, to the investigators' knowledge, only one study has compared these two modalities in older adults and none has broadened the question by comparing several MwT trainings. The goal of this interventional study will be to compare the cognitive, dual-task, and physical effects of 6 physical and/or cognitive programs in healthy but inactive older adults. The main questions it will aims to answer are:

  • Will the Moving While Thinking and Thinking While Moving programs have the same effects?
  • If they have different effects, which will be the best way to improve cognitive, dual-task, and physical functions? The study is being set up between 2023 and 2025 to compare the cognitive, dual- ask and physical effects of 6 programs (3 months, 2 sessions of 1 hour per week). Three experimental MwT programs will be studied: Immersive and interactive wall exergames (I2WE), Complex Cognitive and Motor Activities (2CMA), and exergames with Switch (EXER). They will be compared to an experimental TwM program of stationary bike simultaneous to the Switch (Video games + bike) and 2 control programs: inactive video games (VG) and stationary bike (BIKE). A control group (CON) will be also created. Cognitive, dual-task, and physical pre-tests (before the program), post-tests (after the program), and retention tests (3 months after the end of the program) will be realized to evaluate the effects of the programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

July 13, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

exergamescombined trainingcognitive functiondual taskolder adultsvideo gamesphysical activity

Outcome Measures

Primary Outcomes (5)

  • Change Visuospatial memory

    Visuospatial memory will be evaluated with the Spatial Span Test, a subtest of the Weschler Memory Scale. In the first part, the participant reproduces in the same order a sequence of cubes designated by the examiner. In the second, the participant reproduces a sequence of movements in reverse order. The number of cubes increases progressively and determines the spatial span and the backward spatial span. For each level, the participant always performs 2 trials and scores 1 point for each successful trial. The test ends when 2 errors are made at the same level.

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • Change Flexibility

    Flexibility will be evaluated with the Trail Making Test. Part A consists in linking a series of increasing numbers from 1 to 25 by selecting the appropriate number. In part B, the participants connect 2 series of symbols in alternation: 1 of numbers and 1 of letters. This has to be done without lifting the pen from the paper and as quickly as possible. If mistakes are made, the examiner informs the participant, who has to correct them. Flexibility is highlighted specifically by analyzing the time difference in the result B-A, a purer measure of flexibility.

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • Change Inhibition with witty

    It will be performed with a set of eight semaphores which are equipped with a LED matrix. The participant will be standing, facing a specially designed rack with semaphores. They will have to turn off as fast as possible the lights that appear, according to the instructions given, and will have to move back their hand to the middle of their hips. The tests consist of 20 trials, each trial starts 1500ms after the previous response. The total time to complete the tests will be recorded in milliseconds. In part A, the participant will have to turn off the semaphores that were randomly lit up red. The others remained unenlightened. In part B, the participant will have to turn off the semaphores that were randomly lit up with the green letter O. The others lit up with other colors associated with a letter. In part C, the participant will have to turn off the semaphores randomly lit up with the green letter O. The others lit up in green are associated with another letter.

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • Change cognitive-cognitive Dual task

    To evaluate the cognitive-cognitive Dual Task capacity, the cognitive tasks will be first realized separately as a single task, and then concomitantly. For the Sound counting task, the participant will have to count in their mind the number of high-pitched sounds among low-pitched sounds that they heard, for 2 minutes. At the end of the 2 minutes, the participant will have to give the number of high-pitched sounds counted. The percentage between the number given by the participant and the correct number will be calculated. For the Go no Go Test, the participant will have to press a key as quickly as possible when they see the "X" symbol and not press when they see the "+" symbol, for 2 minutes. The reaction time, the number of correct answers, and errors will be recorded.

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • Change physical-cognitive Dual Task

    To evaluate the physical-cognitive Dual Task capacity, the cognitive and the physical task will be first realized separately as a single task, and then concomitantly. For the Operation counting task, the participant will subtract 7 from a starting number (e.g., 286) as many times as possible for one minute. The number of correct answers, as well as errors, will be recorded. For the STEP test, the participant will do as many repetitions as possible, going up and down a step, one foot after the other, for 2 minutes.

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

Secondary Outcomes (8)

  • Upper body strength change

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • Lower body flexibility change

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • Dynamical balance change

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • Upper body flexibility change

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • Endurance change

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • +3 more secondary outcomes

Other Outcomes (6)

  • Perceived pleasure

    within 1 week after the program

  • Feeling questionnaire

    within 1 week after the program

  • General Lifestyle change

    Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.

  • +3 more other outcomes

Study Arms (7)

I2WE (Immersive and interactive wall exergames)

EXPERIMENTAL
Other: Immersive and Interactive Wall Exergames

2CMA (Complex Cognitive and Motor Activities)

EXPERIMENTAL
Other: Complex Cognitive and Motor Activities program

EXER

EXPERIMENTAL
Other: exergames program

VG (video games)

ACTIVE COMPARATOR
Other: video games program

BIKE (bike)

ACTIVE COMPARATOR
Other: Bike

VG-bike (Video games + bike)

ACTIVE COMPARATOR
Other: Video games + bike

CON (control group)

NO INTERVENTION

Interventions

This intervention will be performed using the Neo One device. It was chosen because of the variety and quality of the games offered which are accessible to older people. The target intensity of core workout will be moderate. Five to 7 five-minutes games will be selected from 19 games. A variety of materials will be used (e.g., basketball, rugby, handball ball, balloon, chair, hoop, rhythm ladder, tennis racket). The games will be made more complex by selecting difficulty settings (easy, normal, hard) and by adding extra exercises to add cooperative and/or oppositional situations to the games where they are not initially implemented and to increase the physical and/or motor complexity. Interventions will last 12 weeks, with 2 sessions of 1-h per week (24 h in total). The sessions will consist in 10 minutes of warmup, 45 minutes of the main session using the Neo One device and 5 minutes of cooldown with full body stretching exercises, in groups of 4 participants.

I2WE (Immersive and interactive wall exergames)

The intervention will last 12 weeks, with 2 sessions of 1-h per week (24 h in total). The sessions will consist in 10 minutes of warmup, 45 minutes of the main sessions involving cooperation and opposition exercises inspired by team sports (basketball, volleyball, rugby) and individual sports (boxing, weight training), and 5 minutes of cooldown with full body stretching exercises, in groups of 6 participants. The target intensity of body workout will be moderate. The first part will be focused on endurance and the second on muscle strengthening and coordination work in the form of circuit training. A variety of equipment will be used (e.g., tennis balls, basketballs, volleyballs, rugby balls, balloons, elastics, chairs, blocks). The number of partners and/or opponents will be changed regularly.

2CMA (Complex Cognitive and Motor Activities)

The intervention will last 12 weeks, with 2 sessions of 1-h per week (24 h in total). The sessions will be performed using the Nintendo Switch device, physically active (standing). The sessions will consist in 10 minutes of warmup, 45 minutes of the main session using the Nintendo Switch device and 5 minutes of cooldown with full body stretching exercises, in groups of 4 participants. The games (Fitness Boxing 2, Switch Sport, Just Dance 2020, 2021, 2023, Let's Get Fit, Mario and Sonic at the Olympic Games Tokyo 2020, Instant Sport, Ring Fit, Zumba Burn It Up!) will be carried out in the form of circuit training, in pairs or groups of 4. The games will be made more complex by selecting difficulty settings (easy, normal, hard) and by adding extra exercises to add cooperative and/or oppositional situations to the games where they are not initially implemented and to increase the physical and/or motor complexity.

EXER

The intervention will last 12 weeks, with 2 sessions of 1-h per week (24 h in total). The sessions will be performed using the Nintendo Switch device, while being inactive (sitting). The sessions will consist in one-hour single and multi-players games, using the Nintendo Switch device, in groups of 6 participants.

VG (video games)
BikeOTHER

The intervention will last 12 weeks, with 2 sessions of 1-h per week (24 h in total). In this active comparator intervention, the sessions will consist in 10 minutes of warmup, 45 minutes of the main sessions involving riding a stationary bike at about 50% of Heart Rate Reserve, and 5 minutes of cooldown with full body stretching exercises, in groups of 6 participants.

BIKE (bike)

The intervention will last 12 weeks, with 2 sessions of 1-h per week (24 h in total). In this experimental arm, the sessions will consist in 10 minutes of warmup, 45 minutes of the main sessions involving riding a stationary bike (like BIKE program at about 50% of Heart Rate Reserve) and at the same time playing on a Nintendo Switch (like VG program), and 5 minutes of cooldown with full body stretching exercises, in groups of 6 participants.

VG-bike (Video games + bike)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be over 60 years old
  • have a MMSE score above 27
  • engage in less than 2.5 hours of physical activity per week assessed by the QAPPA
  • score 3 or higher on a subjective health Likert-scale (1= very poor to 5= very good)
  • be retired
  • have no major pathology
  • have normal or corrected vision and hearing
  • have no difficulty bending or using their shoulders
  • do not frequently play video games or exergames
  • present a medical certificate not contraindicating physical activity).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Club seniors Kennedy

Créteil, 94000, France

Location

Centre Sportif Arthur Ashe

Montreuil, 93100, France

Location

UFR STAPS Paris Cité

Paris, 75015, France

Location

Related Publications (7)

  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PMID: 7154893BACKGROUND
  • de Souto Barreto P. Construct and convergent validity and repeatability of the Questionnaire d'Activite Physique pour les Personnes Agees (QAPPA), a physical activity questionnaire for the elderly. Public Health. 2013 Sep;127(9):844-53. doi: 10.1016/j.puhe.2012.10.018. Epub 2012 Nov 10.

    PMID: 23148890BACKGROUND
  • Eggenberger P, Schumacher V, Angst M, Theill N, de Bruin ED. Does multicomponent physical exercise with simultaneous cognitive training boost cognitive performance in older adults? A 6-month randomized controlled trial with a 1-year follow-up. Clin Interv Aging. 2015 Aug 17;10:1335-49. doi: 10.2147/CIA.S87732. eCollection 2015.

    PMID: 26316729BACKGROUND
  • 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.

    PMID: 1202204BACKGROUND
  • Gellish RL, Goslin BR, Olson RE, McDonald A, Russi GD, Moudgil VK. Longitudinal modeling of the relationship between age and maximal heart rate. Med Sci Sports Exerc. 2007 May;39(5):822-9. doi: 10.1097/mss.0b013e31803349c6.

    PMID: 17468581BACKGROUND
  • Herold F, Hamacher D, Schega L, Muller NG. Thinking While Moving or Moving While Thinking - Concepts of Motor-Cognitive Training for Cognitive Performance Enhancement. Front Aging Neurosci. 2018 Aug 6;10:228. doi: 10.3389/fnagi.2018.00228. eCollection 2018.

    PMID: 30127732BACKGROUND
  • Kraft E. Cognitive function, physical activity, and aging: possible biological links and implications for multimodal interventions. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2012;19(1-2):248-63. doi: 10.1080/13825585.2011.645010.

    PMID: 22313174BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Off-Road Motor Vehicles

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor VehiclesTransportationTechnology, Industry, and Agriculture

Study Officials

  • Alexandra Perrot

    Université Paris-Saclay

    STUDY DIRECTOR
  • Pauline Maillot

    Université Paris Cité

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 14, 2023

Study Start

February 13, 2023

Primary Completion

December 15, 2024

Study Completion

May 15, 2025

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations