Clinical trial NCT05991011: Comparison of the Cognitive, Dual-task and Physical Effects of 6 Programs With Older Adults
Official title: Moving While Thinking or Thinking While Moving? Comparison of the Cognitive, Dual-task and Physical Effects of 6 Programs With Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Fitness
Cognitive Function
Keywords: exergames
combined training
cognitive function
dual task
older adults
video games
physical activity
Lead sponsor: Université Paris-Saclay
Sponsor class: OTHER
Collaborators: name: Université Paris Cité
First posted: 2023-08-14
Enrollment: 168
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change Visuospatial memory
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Change Flexibility
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Change Inhibition with witty
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Change cognitive-cognitive Dual task
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Change physical-cognitive Dual Task
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
Secondary outcomes:
measure: Upper body strength change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Lower body flexibility change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Dynamical balance change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Upper body flexibility change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Endurance change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Upper body strength change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Upper body strength 2 change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Coordination change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
Other outcomes:
measure: Perceived pleasure
timeFrame: within 1 week after the program
measure: Feeling questionnaire
timeFrame: within 1 week after the program
measure: General Lifestyle change
timeFrame: Within 1 week before the program, within 1 week after the program, and 3 months after the end of the program.
measure: Physical effort intensity
timeFrame: up to 12 weeks
measure: perceived physical effort intensity
timeFrame: up to 12 weeks
measure: perceived cognitive effort intensity
timeFrame: up to 12 weeks
Locations:
city: Créteil
country: France
facility: Club seniors Kennedy
city: Montreuil
country: France
facility: Centre Sportif Arthur Ashe
city: Paris
country: France
facility: UFR STAPS Paris Cité
Study officials:
affiliation: Université Paris-Saclay
name: Alexandra Perrot
role: STUDY_DIRECTOR
affiliation: Université Paris Cité
name: Pauline Maillot
role: STUDY_DIRECTOR
References:
citation: Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.