ElderlyNCT04806022
Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly
A study testing Fatigability assessment in people with Elderly, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Fatigability assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2022to 6 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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)
- Conditions
- Elderly
- Being tested
- Fatigability assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigability assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mental Fatigue Task first | Experimental | * 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 Receives: Other: Fatigability assessment |
| Muscle fatigue task first | Experimental | * 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 Receives: Other: Fatigability assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion (day 0)
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.
Measured: at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start19 Jan 2022
- Primary completion30 Sep 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GUERIN, Principal investigator, Nice University Hospital, Gerontology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806022
- Sponsor's protocol ID
- 21-PP-02
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2021
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Piche E, Gerus P, Zory R, Jaafar A, Guerin O, Chorin F. Effects of muscular and mental fatigue on spatiotemporal gait parameters in dual task walking in young, non-frail and frail older adults. Aging Clin Exp Res. 2023 Oct;35(10):2109-2118. doi: 10.1007/s40520-023-02506-8. Epub 2023 Aug 3.
PubMed 37535312
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly
- ClinicalTrials.gov ID
- NCT04806022
- Acronym / sponsor ID
- 21-PP-02
- Conditions
- Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Fatigue Task first | Experimental | Other: Fatigability assessment* 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 |
| Muscle fatigue task first | Experimental | Other: Fatigability assessment* 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 |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- psychiatric disorders
- Severe hearing or vision loss
- Motor or sensory disability that may interfere with test completion
- Old group
- psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigability assessmentEach 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. | Other | Mental Fatigue Task first, Muscle fatigue task first |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 37535312Piche E, Gerus P, Zory R, Jaafar A, Guerin O, Chorin F. Effects of muscular and mental fatigue on spatiotemporal gait parameters in dual task walking in young, non-frail and frail older adults. Aging Clin Exp Res. 2023 Oct;35(10):2109-2118. doi: 10.1007/s40520-023-02506-8. Epub 2023 Aug 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier GUERIN principal investigator
Nice University Hospital, Gerontology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigability assessment in people with Elderly, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual task performance after muscular fatigue (time frame: at inclusion (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.