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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04806022
Other study ID # 21-PP-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2022
Est. completion date October 6, 2022

Study information

Verified date October 2022
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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): 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)


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date October 6, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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
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