Correlates of Fatigue in People With Schizophrenia

NCT06397950 | Terminated

• 1 other identifier: FIZO-2
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia

Keywords

Trait fatigue; Correlates; Physical activity; Sleep; Iatrogenic

Outcome Measures

Primary Outcomes (1)

• Strength of predictive model of fatigue in schizophrenia

  The aim is to determine the relative weight of the measured parameters to explain fatigue variance. * Fatigue score obtained at the MFI-20 will be selected as the dependent variable. * Muscle strength, muscle fatigue, functional abilities, risk of sarcopenia, sleep, cognition, antipsychotic treatment, smoking and coffee consumption, catastrophism, negative symptomatology, and physical activity and sedentary levels will be selected as independent variables. * Variables will be entered in a multiple linear regression to establish a predictive model of fatigue.

  8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables

Secondary Outcomes (1)

• Characterization of fatigued people with schizophrenia

  8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables

Study Arms (1)

Patients with Schizophrenia

Patients are enrolled in a psychosocial rehabilitation program.

Other: Assessment of potential fatigue factors

Interventions

Assessment of potential fatigue factors OTHER

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.

Patients with Schizophrenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be patients with schizophrenia, included in a psychosocial rehabilitation program.

You may qualify if:

• Patient with schizophrenia engaged in a psychosocial rehabilitation process.
• Absence of characterised major depressive episode.
• Patient affiliated or entitled to a social security scheme.
• Obtention of free and informed written consent, as well as the free and informed written consent of the guardian in the case of a patient placed under protection measure (guardianship).

You may not qualify if:

• Physical pain superior to 3 on a visual analog scale.
• History of severe inflammatory pathology or severe brain trauma.
• Medical contraindication to moderate-intensity physical activity practice.
• Patient having electroconvulsive therapy as current treatment.
• Addiction to toxic products such as alcohol, cannabis or other toxic substances other than tobacco.

Sponsors & Collaborators

• GCS CIPS: lead

Study Sites (1)

Clinique INICEA Val Du Fenouillet

La Crau, 83260, France

Location

MeSH Terms

Conditions

Schizophrenia; Motor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Study Officials

• Emmanuel MULIN

  INICEA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: October 11, 2024
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

FR (1)