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Clinical Trials/NCT04504643
NCT04504643
Completed
N/A

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

Aix Marseille Université1 site in 1 country45 target enrollmentOctober 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognitive Decline
Sponsor
Aix Marseille Université
Enrollment
45
Locations
1
Primary Endpoint
Changes in working memory function through HappyNeuron Software
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
April 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aix Marseille Université
Responsible Party
Principal Investigator
Principal Investigator

Jean-Jacques TEMPRADO

Professor

Aix Marseille Université

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

Outcomes

Primary Outcomes

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.

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

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

Time Frame: Through study completion, an average of 9 months

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 global cognition capacity through the Moca test

Time Frame: Through study completion, an average of 9 months

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.

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.

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

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.

Secondary Outcomes

  • Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests(Through study completion, an average of 9 months)
  • Changes in functional mobility through the Timed Up & Go test(Through study completion, an average of 9 months)
  • Changes in motor coordination through the Four- Square Stepping test(Through study completion, an average of 9 months)
  • Changes in cardiovascular capacities through Shuttle walk test(Through study completion, an average of 9 months)
  • Changes for flexibility through the Chair-sit and reach test(Through study completion, an average of 9 months)
  • Changes in Gait pattern assessment(Through study completion, an average of 9 months)
  • Changes in muscular strength through Maximal handgrip force test(Through study completion, an average of 9 months)

Study Sites (1)

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