- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806022
Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly
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):
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)
7 resting days
Second appointment (day 7)
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)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06000
- CHU de Nice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
Investigators
- Principal Investigator: Olivier GUERIN, Nice University Hospital, Gerontology Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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