Clinical trial NCT04573712: The Effects of Apathy on Different Forms of Fatigue
Official title: FAME 1: The Effects of Apathy on Different Forms of Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apathy
Fatigue
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 57
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Memoire Ressources et Recherche, CHU de Nice
Study officials:
affiliation: CHU de NICE, Centre Mémoire Ressources et Recherches
name: Philippe ROBERT, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daumas L, Zory R, Robert P, Manera V. Apathetic patients with neurocognitive disorders are more fatigued and fatigable. Aging Clin Exp Res. 2022 Sep;34(9):2237-2241. doi: 10.1007/s40520-022-02146-4. Epub 2022 May 24.