- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Nice, Frankrike, 06000
- CHU de Nice
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Dual task performance after muscular fatigue
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Olivier GUERIN, Nice University Hospital, Gerontology Department
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 21-PP-02
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Fatigability assessment
-
Thomas Jefferson UniversityFullførtHematopoetisk og lymfoid celle-neoplasma | Ondartet fast neoplasmaForente stater
-
University of WinchesterUniversity College DublinFullførtSlag | Fysisk aktivitet | Gangart, hemiplegiskStorbritannia
-
University Hospital, LilleFullførtKognitivt symptom | Evalueringer, Diagnostisk selvFrankrike
-
University of WolverhamptonThe Royal Wolverhampton Hospitals NHS TrustRekrutteringAvansert prostatakarsinomStorbritannia
-
Texas Woman's UniversityFullførtAutismespektrumforstyrrelse
-
University of OklahomaRekrutteringHode- og nakkekreftForente stater
-
Alzheimer's Light LLCRekrutteringMultippel sklerose | Parkinsons sykdom | Alzheimers sykdom | Mild kognitiv svikt | Frontotemporal demens | Vaskulær demens | TBIForente stater
-
Izmir Katip Celebi UniversityFullførtHemiplegi, spastiskTyrkia
-
Mansoura University HospitalFullførtIskemisk hjerneslag | Kognitiv svikt | Utfall, fataltEgypt
-
Neurobehavioral Systems, Inc.National Institutes of Health (NIH)RekrutteringAlzheimers sykdom | Aldring | Kognitiv nedgangForente stater