NCT04806022

Brief Summary

The dual task (walking and cognitive task at the same time) is increasingly used in geriatrics in protocols for detecting people who are falling and/or for highlighting cognitive disorders. However, frail elderly people tend to get tired quickly and a lack of awareness of the effects of fatigue on dual-task performance could alter the diagnosis. There are two types of fatigue: mental fatigue and peripheral muscle fatigue. Each participant will do both types of fatigue over 2 appointments spaced by 7 days so that the subject can recover from induced fatigue. The sequence of fatigue tasks will be randomized. At the first appointment (day 0):

  • The subject must walk on 10m with round trip for 1min.
  • the subject must do the arithmetic count of 3 in 3
  • Then comes the evaluation in double task (walking and counting at once for 1min). The subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time.
  • mental fatigue task or muscle fatigue task (randomized)
  • post-fatigue assessment (the same as pre-fatigue assessment)
  • Pre-fatigue assessment :
  • The subject must walk on 10m with round trip for 1min.
  • the subject must do the arithmetic count of 3 in 3
  • Then comes the evaluation in double task (walking and counting at once for 1min). The subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time.
  • mental fatigue task or muscle fatigue task (randomized)
  • post-fatigue assessment (the same as pre-fatigue assessment)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2022

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 10, 2021

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Dual task performance after muscular fatigue

    Dual task performance (DTEspeed motor performance; DTEcog cognitive performance) will be compared before and after a protocol of peripheral mental and muscular fatigue. For Dual Task Performance, the cognitive task performance (maximum count count - error count) performed alone (single ST task) and performed while walking (double ST task) will be compared.

    at inclusion (day 0)

  • Dual task performance after cognitive fatigue

    Dual task performance (DTEspeed motor performance; DTEcog cognitive performance) will be compared before and after a protocol of peripheral mental and muscular fatigue. For Dual Task Performance, the cognitive task performance (maximum count count - error count) performed alone (single ST task) and performed while walking (double ST task) will be compared.

    at day 7

Study Arms (2)

Mental Fatigue Task first

EXPERIMENTAL

* First appointment : 1. Pre-fatigue assessment 2. mental fatigue task 3. post-fatigue assessment * 7 resting days * second appointment 1. Pre-fatigue assessment 2. Muscle fatigue task 3. post-fatigue assessment

Other: Fatigability assessment

Muscle fatigue task first

EXPERIMENTAL

* First appointment : 1. Pre-fatigue assessment 2. Muscle fatigue task 3. post-fatigue assessment * 7 resting days * second appointment 1. Pre-fatigue assessment 2. mental fatigue task 3. post-fatigue assessment

Other: Fatigability assessment

Interventions

Each participant will do both types of fatigue over 2 appointments spaced by 7 days so that the subject can recover from induced fatigue. The sequence of fatigue tasks will be randomized.

Mental Fatigue Task firstMuscle fatigue task first

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 40 years old

You may not qualify if:

  • psychiatric disorders
  • Severe hearing or vision loss
  • Motor or sensory disability that may interfere with test completion
  • Old group
  • to 90 years old
  • less than 3 Fried's criteria of fragility
  • walking ability without technical assistance (at least 10m).
  • psychiatric disorders
  • Severe hearing or vision loss
  • Motor or sensory disability that may interfere with test completion
  • Old frail group
  • to 90 years old
  • or more Fried's criteria of fragility
  • walking ability without technical assistance (at least 10m).
  • psychiatric disorders
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

Related Publications (1)

  • Piche E, Gerus P, Zory R, Jaafar A, Guerin O, Chorin F. Effects of muscular and mental fatigue on spatiotemporal gait parameters in dual task walking in young, non-frail and frail older adults. Aging Clin Exp Res. 2023 Oct;35(10):2109-2118. doi: 10.1007/s40520-023-02506-8. Epub 2023 Aug 3.

Study Officials

  • Olivier GUERIN

    Nice University Hospital, Gerontology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 19, 2021

Study Start

January 19, 2022

Primary Completion

September 30, 2022

Study Completion

October 6, 2022

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations