Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02864576
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2016-07-26
Brief Title:
Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
Cognitive remediation CR and aerobic exercise have separately shown promising results in schizophrenia cognitive improvement despite this the impact in improving functionality is still limited Aerobic exercise increases Brain Derived Neurotrophic Factor BDNF levels promoting neuronal and cognitive plasticity which can maximize the impacts of CR The aim of this randomized controlled trial is to study the efficacy of a 3-month intensive program that combines CR plus physical exercise comparing it to cognitive remediation plus a control activity
Detailed Description:
Cognitive remediation CR and physical exercise have separately shown promising results in schizophrenia cognitive improvement despite this the impact in improving functionality is still limited Physical exercise increases Brain Derived Neurotrophic Factor BDNF levels promoting neuronal and cognitive plasticity which can maximize the impact of CR The aim of this project is to study the efficacy of an intensive program 3 months that combines CR and physical exercise by a randomized controlled trial where 74 patients with chronic schizophrenia will be randomized to two groups 1 CR plus physical exercise 2 CR plus control activity health promotion Primary outcome measures will be cognitive performance functional outcome negative symptoms and BDNF levels Measures will be blindly assessed at baseline at 3 months follow up and at 15 months follow up The investigators expect that i the CR plus physical exercise will be superior to CR plus control activity in improving cognition functional outcome negative symptoms and in increasing BDNF levels in the short and medium term 3 and 15 months ii changes in BDNF levels after the CR plus physical exercise will be an adequate biomarker of the cognitive improvement obtained with this treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None