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

NCT ID: NCT04806022

Last Updated: 2022-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2022-10-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elderly

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Fatigability assessment

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

Fatigability assessment

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fatigability 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 20 to 40 years old


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


* 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

Old group


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

Old frail group


* psychiatric disorders
* Severe hearing or vision loss
* Motor or sensory disability that may interfere with test completion
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Olivier GUERIN

Role: PRINCIPAL_INVESTIGATOR

Nice University Hospital, Gerontology Department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Nice

Nice, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-PP-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Successful Aging and Frailty
NCT03963050 UNKNOWN NA