NCT05991011

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

Moving While Thinking or Thinking While Moving? Comparison of the Cognitive, Dual-task and Physical Effects of 6 Programs With Older Adults

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Alexandra Perrot · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Physical Fitness
• Cognitive Function

Interventions

Type	Name	Description
OTHER	Immersive and Interactive Wall Exergames	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.
OTHER	Complex Cognitive and Motor Activities program	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.
OTHER	exergames program	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.
OTHER	video games program	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.
OTHER	Bike	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.
OTHER	Video games + 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.

Timeline

• Start date: 2023-02-13
• Primary completion: 2024-12-15
• Completion: 2025-05-15
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

3 sites across 1 country: France