Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly

October 6, 2022 updated by: Centre Hospitalier Universitaire de Nice

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):

  1. 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.
  2. mental fatigue task or muscle fatigue task (randomized)
  3. post-fatigue assessment (the same as pre-fatigue assessment)

7 resting days

Second appointment (day 7)

  1. 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.
  2. mental fatigue task or muscle fatigue task (randomized)
  3. post-fatigue assessment (the same as pre-fatigue assessment)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nice, France, 06000
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Young group

Inclusion Criteria:

  • 20 to 40 years old

Exclusion Criteria:

  • psychiatric disorders
  • Severe hearing or vision loss
  • Motor or sensory disability that may interfere with test completion

Old group

Inclusion Criteria:

  • 65 to 90 years old
  • less than 3 Fried's criteria of fragility
  • walking ability without technical assistance (at least 10m).

Exclusion Criteria:

  • psychiatric disorders
  • Severe hearing or vision loss
  • Motor or sensory disability that may interfere with test completion

Old frail group

Inclusion Criteria:

  • 65 to 90 years old
  • 3 or more Fried's criteria of fragility
  • walking ability without technical assistance (at least 10m).

Exclusion Criteria:

  • psychiatric disorders
  • Severe hearing or vision loss
  • Motor or sensory disability that may interfere with test completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mental Fatigue Task first
  • 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
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.
Experimental: Muscle fatigue task first
  • 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dual task performance after muscular fatigue
Time Frame: at inclusion (day 0)

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
Time Frame: at day 7

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olivier GUERIN, Nice University Hospital, Gerontology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

October 6, 2022

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-PP-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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