- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04504643
Comparison of Three Motor-cognitive Training Programs (EXECO)
Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Jacques Temprado, Ph.D.
- Phone Number: +33 4 91 17 22 55
- Email: jean-jacques.temprado@univ-amu.fr
Study Locations
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Marseille, France
- Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)
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Contact:
- Jean-Jacques Temprado, Ph.D.
- Phone Number: +33 4 91 17 22 55
- Email: jean-jacques.temprado@univ-amu.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Technology-assisted circuit training
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.
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Circuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks
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Experimental: Conventional circuit training
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).
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Conventional circuit training including single and dual task 3 times a week for one hour during 8 weeks
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Experimental: Nordic Walking
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.
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Classic nordic walking 3 times a week for one hour during 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in working memory function through HappyNeuron Software
Time Frame: Through study completion, an average of 9 months
|
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.
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Through study completion, an average of 9 months
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Changes in inhibition processes through Stroop task test
Time Frame: Through study completion, an average of 9 months
|
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.
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Through study completion, an average of 9 months
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Changes in switching capacities through Trial Making Test part A and part B (TMT-A and TMT-B)
Time Frame: Through study completion, an average of 9 months
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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
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Changes in visuospatial capacities through Rey complex Figure copy task
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Changes in dual task capacities through Walking Oral Trail Making Test part A and part B (OTMT-A and OTMT-B)
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Changes in global cognition capacity through the Moca test
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Changes in Gait pattern assessment
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Changes in functional mobility through the Timed Up & Go test
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Changes for flexibility through the Chair-sit and reach test
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Changes in motor coordination through the Four- Square Stepping test
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Changes in muscular strength through Maximal handgrip force test
Time Frame: Through study completion, an average of 9 months
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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.
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Through study completion, an average of 9 months
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Changes in cardiovascular capacities through Shuttle walk test
Time Frame: Through study completion, an average of 9 months
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Jacques Temprado, Ph.D., Aix Marseille Université
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A03263-54
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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