FAME1: The Effects of Apathy on Different Forms of Fatigue

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04573712
Collaborator
(none)
60
1
1
17.9
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Follow up and Assessment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
FAME 1: The Effects of Apathy on Different Forms of Fatigue
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fatigue Severity Scale scores assessment

Fatigue Severity Scale scores assessment

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...)

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Memoire Ressources et Recherche, CHU de Nice Nice France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Philippe ROBERT, PU-PH, CHU de NICE, Centre Mémoire Ressources et Recherches

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04573712
Other Study ID Numbers:
  • 20-PP-20
First Posted:
Oct 5, 2020
Last Update Posted:
Oct 6, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2020