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Correlates of Fatigue in People With Schizophrenia

NCT06397950 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2025-07-31

No results posted yet for this study

Summary

The goal of this experimental prospective study is to build an explicative model of trait fatigue in adults with schizophrenia engaged in a psychosocial rehabilitation process.

The main questions it aims to answer are:

* Which factors amongst those evaluated explain the most of fatigue variance in people with schizophrenia?
* Which clinical factors characterise the most fatigued participants compared to less fatigued participants?

Participants will wear an accelerometer for seven days to assess their sedentary and physical activity behaviours as well as their sleep.

After this, they will undergo an experimental visit, to asses:

* Fatigue
* Cognitive function
* Tobacco and caffeine consumption
* Fatigue catastrophizing
* Sleep quality
* Sarcopenia risk
* Functional capacities
* Handgrip strength
* Quadriceps maximal strength and fatigability

Conditions

Interventions

OTHER

Assessment of potential fatigue factors

3 visits will be carried out: V0: Inclusion V1: Familiarization visit V2: Experimental visit V1 * Completion of MFI-20 questionnaire for familiarisation. * Information about accelerometry and activity journal use will be delivered to the patient. * The participant will be equipped with an accelerometer and asked to complete the activity journal for seven days. V2 * Completion of questionnaires: MFI-20, GATS tobacco consumption questionnaire, caffeine consumption questionnaire, Fatigue Catastrophizing Scale, PSQI. * Assessment of cognitive function: Sustained Attention to Response Task (SART), AX-Continuous Performance Task (AX-CPT) and verbal fluency test (animals and P categories). * Assessment of physical evaluation: isometric evaluation of maximal handgrip strength, one-minute sit-to-stand test, isometric evaluation of maximal quadriceps strength, QIF test. Negative symptoms will be assessed. Calf circumference will be measured for sarcopenia risk.

Sponsors & Collaborators

  • GCS CIPS

    lead OTHER

Principal Investigators

  • Emmanuel MULIN · INICEA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-11
Primary Completion
2025-07-29
Completion
2025-07-29

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397950 on ClinicalTrials.gov