The Effects of Apathy on Different Forms of Fatigue

Fatigue Clinical Trial

— FAME1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573712
• Other study ID #: 20-PP-20
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Apathy
• Fatigue

Intervention

Other:
• Follow 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...)

Locations

Country	Name	City	State
France	Centre Memoire Ressources et Recherche, CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.	the minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)	at inclusion