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The Effects of Apathy on Different Forms of Fatigue

FAME 1: The Effects of Apathy on Different Forms of Fatigue

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04573712
Acronym
FAME1
Enrollment
57
Registered
2020-10-05
Start date
2021-01-14
Completion date
2021-12-21
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apathy, Fatigue

Brief summary

60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital and from the " Fragilily " Platform of the Nice University Hospital. After verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity. Afterwards, participants will have to complete assessments and questionnaires to evaluate apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale). Regarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game 'Tap-piscine'). The total duration of the evaluation is a maximum of 2 hours.

Interventions

OTHERFollow up and Assessment

each patient should wear an actigraph during a week and will be do some tests during 2hours (6min walk, apathy inventory, fatigue severity scale etc...)

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Men or women aged between 65 and 85 years old coming for consultation at the RMC and the Fragility Platform * DSM-5 diagnosis: minor neurocognitive disorders * Subject must read and write in French. * Subject must be registered in the national social security scheme. * Ability to sign free and informed consent. For the 'apathetic' group: \- Presence of apathy/emotional symptoms: at least 2 criteria according to the diagnostic criteria for apathy and a score higher than 8.5 in the MBI affective dimension. For the 'non-apathetic' group: \- Absence of apathy/emotional symptoms: no criteria according to the diagnostic criteria for apathy and a score of less than 8.5 in the MBI affective dimension.

Exclusion criteria

* Motor or sensory disabilities likely to interfere with the tests. * Presence of major psychiatric disorders (e.g., schizophrenia, major depressive episode, bipolar disorder) * Patient under guardianship, curatorship or under legal protection

Design outcomes

Primary

MeasureTime frameDescription
comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.at inclusionthe minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPhilippe ROBERT, PU-PH

CHU de NICE, Centre Mémoire Ressources et Recherches

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026