The Effects of Apathy on Different Forms of Fatigue

Not Applicable

Completed

• Conditions: Apathy; Fatigue
• Interventions: Other: Follow up and Assessment

• Registration Number: NCT04573712
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-05
• Study Start: 2021-01-14
• Primary Completion: 2021-12-21
• Study Completion: 2021-12-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fatigue Severity Scale scores assessment	Follow up and Assessment	Fatigue Severity Scale scores assessment

Primary Outcome Measures

Name	Time	Method
comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.	at inclusion	the minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)

Trial Locations

Locations (1)

Centre Memoire Ressources et Recherche, CHU de Nice; 🇫🇷 Nice, France