NCT04504643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

August 2, 2020

Last Update Submit

February 15, 2024

Conditions

Keywords

aging, cognition, cognitive-motor training, Nordic walking

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (7)

  • Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests

    Through study completion, an average of 9 months

  • Changes in Gait pattern assessment

    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 for flexibility through the Chair-sit and reach 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

  • +2 more secondary outcomes

Study Arms (3)

Technology-assisted circuit training

EXPERIMENTAL

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.

Other: Technology-assisted circuit training

Conventional circuit training

EXPERIMENTAL

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).

Other: Conventional circuit training

Nordic Walking

EXPERIMENTAL

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.

Other: Nordic walking

Interventions

Circuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks

Technology-assisted circuit training

Conventional circuit training including single and dual task 3 times a week for one hour during 8 weeks

Conventional circuit training

Classic nordic walking 3 times a week for one hour during 8 weeks

Nordic Walking

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Marseille, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Jean-Jacques Temprado, Ph.D.

    Aix Marseille Université

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2020

First Posted

August 7, 2020

Study Start

October 1, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations