Comparison of Three Motor-cognitive Training Programs

Cognitive Decline Clinical Trial

— EXECO  

Official title:

Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504643
• Other study ID #: 2019-A03263-54
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2024
• Source: Aix Marseille Université
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Understanding how to delay age-related physical and mental declines is an issue for aging research. It has been shown that isolated aerobic, coordination and cognitive training improve brain functions and cognitive performances. Moreover, the combination of them leads to greater effects. Different combination modalities are possible: training programs demanding cognitive resources within the activity performed in a natural environment like Nordic Walking (or Tai chi, Dance...); or as in a conceptually-grounded circuit training where training components are systematically combined and their intensity controlled. The aim of this study is to compare three training programs: a Nordic walking one (NW), and two conceptual grounded, circuits training (CT-c; CT-fit). CT-c implemented by dual-task (DT) exercises, while CT-fit characterized by cognitive charge embodied in the movements through the use of technology. An improvement in physical, motor, and cognitive functions is expected by all three groups. However, our primary hypothesis is that the CT-fit will impact executive functions more. 45 healthy independent living community dwellers participants aged 65 to 80 will be recruited. Participants will be included after a general medical examination (geriatric screening and cycle-ergometer maximal effort test). The main exclusion criteria are signs of cognitive impairment, (MMSE <26/30), and physical impairments. Participants will be randomly divided into the 3 groups (NW, CT-c, CT-fit): The training program will last 8 weeks, 1 hour 3 times a week. Pre and post-tests will include cognitive assessment (MoCA; TMT; Stroop task, Happy Neuron™ working memory test, Rey Complex Figure copy task and dual-task capacities through the DT-OTMT); motor fitness assessment (Bipedal upright standing, Unipedal balance test, walking speed and size of the base of support, Timed Up & Go, Chair sit and reach test and Four square stepping test) and physical assessment (10 m incremental shuttle walking test, maximal handgrip force, 30s chair rise stand). Improving cognitive functions by adding new technology embodied in a systematically combined training (exergame), would result to be the best solution to optimize training for aging people.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• Considered apt for moderate physical activity practice (validated by a maximal VO2 cycle-ergometer test by a cardiologist)
• Sedentary or moderately active (objectified by the categories obtained at the IPAQ)
• Cognitively healthy (objectified by a score at the MMSE of 26 and above)

Exclusion Criteria:

• Colorblindness
• Uncorrected earing and/or visual impairment
• Presence of a known psychiatric or neurologic condition
• Under psychotropic treatment or beta-blockers

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• Technology-assisted circuit training
Circuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks
• Conventional circuit training
Conventional circuit training including single and dual task 3 times a week for one hour during 8 weeks
• Nordic walking
Classic nordic walking 3 times a week for one hour during 8 weeks

Locations

Country	Name	City	State
France	Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Aix Marseille Université

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in working memory function through HappyNeuron Software	Assessment for changing in working memory function tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Primary	Changes in inhibition processes through Stroop task test	Assessment for changing of inhibition processes tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Primary	Changes in switching capacities through Trial Making Test part A and part B (TMT-A and TMT-B)	Assessment for changing of switching capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Primary	Changes in visuospatial capacities through Rey complex Figure copy task	Assessment for changing of visuospatial capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Primary	Changes in dual task capacities through Walking Oral Trail Making Test part A and part B (OTMT-A and OTMT-B)	Assessment for chainging for dual task capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Primary	Changes in global cognition capacity through the Moca test	Assessment for changing for general cognition tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Secondary	Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests	Assessment for balance using a force platform for the bipedal upright standing (AMTI, Advanced Mechanical Technology, Inc., MA, USA). Both assessments tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Secondary	Changes in Gait pattern assessment	Assessment to test gait pattern using a Gait rite (walking at usual speed on a gait rite - GAITRite system, CIR Systems, Havertown, PA, United States) tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Secondary	Changes in functional mobility through the Timed Up & Go test	Assessment for functional mobility tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Secondary	Changes for flexibility through the Chair-sit and reach test	Assessment for functional flexibility tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Secondary	Changes in motor coordination through the Four- Square Stepping test	Assessment for functional motor coordination tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Secondary	Changes in muscular strength through Maximal handgrip force test	Assessment for muscular strength (using JAMAR® hand dynamometer) tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months
Secondary	Changes in cardiovascular capacities through Shuttle walk test	Assessment for cardiovascular capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.	Through study completion, an average of 9 months