The Effects of Apathy on Different Forms of Fatigue (FAME1)

November 16, 2023 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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...)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2021

Primary Completion (Actual)

December 21, 2021

Study Completion (Actual)

December 21, 2021

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-PP-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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