Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
8 participants
OBSERVATIONAL
2024-10-11
2025-07-29
Brief Summary
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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
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Detailed Description
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Fatigue has a high prevalence in schizophrenia. Unfortunately, fatigue has negative repercussions on daily living activities in this population, and no effective treatment has been identified for now. The lack of effective strategies to manage fatigue in schizophrenia can be due to the lack of knowledge about factors that can explain fatigue. As such, an explicative model of fatigue in schizophrenia has yet to be established.
Because fatigue is a complex and multifactorial mechanism, investigating its correlates could allow to propose new avenues for its multidisciplinary management, in order to delay its onset or minimize its negative impact. In comparison to healthy subjects, people with schizophrenia show increased physical inactivity and sedentary levels, worsened physical fitness and higher risks of sarcopenia, disturbed sleep, altered cognitive function, increased consumption of psychoactive substances (coffee and tobacco), an increased fatigue catastrophizing. Moreover, negative symptoms could also be linked to fatigue as it has been shown that fatigue could contribute to anhedonia in schizophrenia. Finally, antipsychotic medication can induce sedation, overlapping with fatigue, contributing to an exacerbated experience of the symptom.
Therefore, the goal of this study is to investigate whether physical inactivity, sedentary behaviour, physical fitness, sarcopenia risk, sleep, cognitive capacities, psychoactive substance consumption, fatigue catastrophizing, antipsychotic treatment and negative symptoms could contribute to fatigue in people in schizophrenia.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with Schizophrenia
Patients are enrolled in a psychosocial rehabilitation program.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patient with a stabilised evolution according to usual literature criteria (no modification or increase in antipsychotic treatment during the 4 weeks prior to inclusion).
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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GCS CIPS
OTHER
Responsible Party
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Principal Investigators
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Emmanuel MULIN
Role: PRINCIPAL_INVESTIGATOR
INICEA
Locations
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Clinique INICEA Val Du Fenouillet
La Crau, , France
Countries
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Other Identifiers
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FIZO-2
Identifier Type: -
Identifier Source: org_study_id
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