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

Primary Purpose

Elderly

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fatigability assessment
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Elderly

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mental Fatigue Task first

Muscle fatigue task first

Arm Description

First appointment : Pre-fatigue assessment mental fatigue task post-fatigue assessment 7 resting days second appointment Pre-fatigue assessment Muscle fatigue task post-fatigue assessment

First appointment : Pre-fatigue assessment Muscle fatigue task post-fatigue assessment 7 resting days second appointment Pre-fatigue assessment mental fatigue task post-fatigue assessment

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2021
Last Updated
October 6, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04806022
Brief Title
Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly
Official Title
Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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): 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mental Fatigue Task first
Arm Type
Experimental
Arm Description
First appointment : Pre-fatigue assessment mental fatigue task post-fatigue assessment 7 resting days second appointment Pre-fatigue assessment Muscle fatigue task post-fatigue assessment
Arm Title
Muscle fatigue task first
Arm Type
Experimental
Arm Description
First appointment : Pre-fatigue assessment Muscle fatigue task post-fatigue assessment 7 resting days second appointment Pre-fatigue assessment mental fatigue task post-fatigue assessment
Intervention Type
Other
Intervention Name(s)
Fatigability assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dual task performance after muscular fatigue
Description
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.
Time Frame
at inclusion (day 0)
Title
Dual task performance after cognitive fatigue
Description
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.
Time Frame
at day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GUERIN
Organizational Affiliation
Nice University Hospital, Gerontology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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

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