Comparison of the Cognitive, Dual-task and Physical Effects of 6 Programs With Older Adults

Alexandra Perrot

Status: Enrolling

Conditions: Physical Fitness; Cognitive Function

Treatments: Other: Video games + bike; Other: Bike; Other: exergames program; Other: video games program; Other: Immersive and Interactive Wall Exergames; Other: Complex Cognitive and Motor Activities program

Study type: Interventional

Funder types: Other

Identifiers

NCT05991011

UParis-Saclay

Details and patient eligibility

About

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.

Full description

All subjects must give their informed consent for inclusion before they participate in the study. The study will be conducted in accordance with the Declaration of Helsinki, and the protocol has been approved by the University Paris Saclay Ethics Committee of Research (N°462) who stated that a Protection of Persons Committee was not necessary. The sample size calculation was performed using G. Power. The investigators calculated a sample size sufficient to detect small effect sizes (η2 = .04). Therefore, f = 0.20, α = 0.05, p = 0.95, power = 0.95, were chosen to favor clinically significant effect sizes. To test the main hypotheses of the present study, 133 participants are required. To compensate for possible dropouts, 35 more participants will be included. The 7 groups will be composed of 24 participants each, for a total of 168 participants.

The training interventions will be carried out in different places and at different times:

• Montreuil for I2WE and 2CMA (February to May 2023)
• Créteil for EXER (September to December 2023)
• Paris for BIKE and VG-BIKE (February to May 2024)
• Orsay for VG (September to December 2023). Pre- and post-tests will be carried out before and after the training period to evaluate the cognitive, DT, and physical benefits of each program, and retention tests 3 months after the end of the program.

Statistical analysis plan: Data will be analyzed with JASP software. The statistical analysis will allow us to determine the effects of the 7 different groups on the cognitive, DT, and physical functions. The analysis will include only subjects who completed all the pre- and post-tests. Data from the pre-tests, post-tests, and retention tests will be presented using descriptive statistics (mean, standard deviation) to describe the participants' characteristics and performances on assessments. Before performing the inferential statistical tests, all relevant hypotheses will be tested, and if they are met, statistical analysis will be conducted. For primary and secondary measures, repeated ANOVA will be used to test the interaction between pre-test, post-test, retention test x training groups. If a significant interaction is found, a Bonferroni post-hoc test will be performed. Effects sizes will be calculated to study the power of the results.

Enrollment: 168 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 7 patient groups

I2WE (Immersive and interactive wall exergames)

Experimental group

Treatment:

Other: Immersive and Interactive Wall Exergames

2CMA (Complex Cognitive and Motor Activities)

Experimental group

Treatment:

Other: Complex Cognitive and Motor Activities program

EXER

Experimental group

Treatment:

Other: exergames program

VG (video games)

Active Comparator group

Treatment:

Other: video games program

BIKE (bike)

Active Comparator group

Treatment:

Other: Bike

VG-bike (Video games + bike)

Active Comparator group

Treatment:

Other: Video games + bike

CON (control group)

No Intervention group