Clinical trial NCT04504643: Comparison of Three Motor-cognitive Training Programs
Official title: Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Keywords: aging, cognition, cognitive-motor training, Nordic walking
Lead sponsor: Aix Marseille Université
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in working memory function through HappyNeuron Software
timeFrame: Through study completion, an average of 9 months
measure: Changes in inhibition processes through Stroop task test
timeFrame: Through study completion, an average of 9 months
measure: Changes in switching capacities through Trial Making Test part A and part B (TMT-A and TMT-B)
timeFrame: Through study completion, an average of 9 months
measure: Changes in visuospatial capacities through Rey complex Figure copy task
timeFrame: Through study completion, an average of 9 months
measure: Changes in dual task capacities through Walking Oral Trail Making Test part A and part B (OTMT-A and OTMT-B)
timeFrame: Through study completion, an average of 9 months
measure: Changes in global cognition capacity through the Moca test
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests
timeFrame: Through study completion, an average of 9 months
measure: Changes in Gait pattern assessment
timeFrame: Through study completion, an average of 9 months
measure: Changes in functional mobility through the Timed Up & Go test
timeFrame: Through study completion, an average of 9 months
measure: Changes for flexibility through the Chair-sit and reach test
timeFrame: Through study completion, an average of 9 months
measure: Changes in motor coordination through the Four- Square Stepping test
timeFrame: Through study completion, an average of 9 months
measure: Changes in muscular strength through Maximal handgrip force test
timeFrame: Through study completion, an average of 9 months
measure: Changes in cardiovascular capacities through Shuttle walk test
timeFrame: Through study completion, an average of 9 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)
Study officials:
affiliation: Aix Marseille Université
name: Jean-Jacques Temprado, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: