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Comparison of Three Motor-cognitive Training Programs (EXECO)

Primary Purpose

Cognitive Decline

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Technology-assisted circuit training
Conventional circuit training
Nordic walking
Sponsored by
Aix Marseille Université
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline focused on measuring aging, cognition, cognitive-motor training, Nordic walking

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Technology-assisted circuit training

Conventional circuit training

Nordic Walking

Arm Description

Multicomponent circuit training using FItLight Trainer™ as an embodied tool to perform motor task. The circuit training is composed by aerobic, muscular, coordination and balance exercises.

Multicomponent circuit training composed by aerobic, muscular, balance and coordination exercises. Coordination exercises wll be charged of simple dual task cognitive exercises (counting backwards, or making some easy math calculations, repeating words backward, finding words of the same family).

The training sessions are performed in a natural parc, which offers pathways of different lengths and levels of difficulty that will increase over the weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 2, 2020
Last Updated
August 5, 2020
Sponsor
Aix Marseille Université
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1. Study Identification

Unique Protocol Identification Number
NCT04504643
Brief Title
Comparison of Three Motor-cognitive Training Programs
Acronym
EXECO
Official Title
Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aix Marseille Université

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline
Keywords
aging, cognition, cognitive-motor training, Nordic walking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technology-assisted circuit training
Arm Type
Experimental
Arm Description
Multicomponent circuit training using FItLight Trainer™ as an embodied tool to perform motor task. The circuit training is composed by aerobic, muscular, coordination and balance exercises.
Arm Title
Conventional circuit training
Arm Type
Experimental
Arm Description
Multicomponent circuit training composed by aerobic, muscular, balance and coordination exercises. Coordination exercises wll be charged of simple dual task cognitive exercises (counting backwards, or making some easy math calculations, repeating words backward, finding words of the same family).
Arm Title
Nordic Walking
Arm Type
Experimental
Arm Description
The training sessions are performed in a natural parc, which offers pathways of different lengths and levels of difficulty that will increase over the weeks.
Intervention Type
Other
Intervention Name(s)
Technology-assisted circuit training
Intervention Description
Circuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks
Intervention Type
Other
Intervention Name(s)
Conventional circuit training
Intervention Description
Conventional circuit training including single and dual task 3 times a week for one hour during 8 weeks
Intervention Type
Other
Intervention Name(s)
Nordic walking
Intervention Description
Classic nordic walking 3 times a week for one hour during 8 weeks
Primary Outcome Measure Information:
Title
Changes in working memory function through HappyNeuron Software
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in inhibition processes through Stroop task test
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in switching capacities through Trial Making Test part A and part B (TMT-A and TMT-B)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in visuospatial capacities through Rey complex Figure copy task
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in dual task capacities through Walking Oral Trail Making Test part A and part B (OTMT-A and OTMT-B)
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in global cognition capacity through the Moca test
Description
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.
Time Frame
Through study completion, an average of 9 months
Secondary Outcome Measure Information:
Title
Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in Gait pattern assessment
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in functional mobility through the Timed Up & Go test
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes for flexibility through the Chair-sit and reach test
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in motor coordination through the Four- Square Stepping test
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in muscular strength through Maximal handgrip force test
Description
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.
Time Frame
Through study completion, an average of 9 months
Title
Changes in cardiovascular capacities through Shuttle walk test
Description
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.
Time Frame
Through study completion, an average of 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Jacques Temprado, Ph.D.
Phone
+33 4 91 17 22 55
Email
jean-jacques.temprado@univ-amu.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Temprado, Ph.D.
Organizational Affiliation
Aix Marseille Université
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Temprado, Ph.D.
Phone
+33 4 91 17 22 55
Email
jean-jacques.temprado@univ-amu.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Three Motor-cognitive Training Programs

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