Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397950
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Correlates of Fatigue in People with Schizophrenia
Sponsor:
GCS CIPS
Organization:
GCS CIPS
Study Overview
Official Title:
Correlates of Fatigue in People with Schizophrenia
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIZO-2
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
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
Detailed Description:
Schizophrenia is a severe mental illness affecting about 1 of worldwide population Diagnostic relies on multiple symptoms divided into three main categories positive symptoms negative symptoms and cognitivedissociative symptoms Antipsychotic medication is actually the main pharmacologic treatment in schizophrenia but adverse effects can exacerbate other symptoms such as fatigue
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None