The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: Standard Psychiatric Treatment; Behavioral: Aerobic Exercise

• Registration Number: NCT01897064
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

The aim of this study is to look at the effects of Aerobic Exercise (AE) on daily and neurocognitive functioning including memory, attention, the ability to plan activities, and learn new information. Participants will be assigned by chance to receive regular care or exercise sessions in addition to regular care. This study will allow determining the potential positive influence of AE on cognitive and daily functioning in individuals with schizophrenia.

Detailed Description

Individuals with schizophrenia often display cognitive difficulties. Studies among non-clinical populations suggest that Aerobic Exercise (AE) training is effective in increasing both aerobic fitness and cognitive functioning. However, these associations have not been studied among individuals with schizophrenia, despite the presence of highly sedentary lifestyle in this population To elucidate this putative link, the present study will evaluate the influence of AE on cognitive functioning and daily functioning in individuals with schizophrenia using a single-blind, randomized clinical trial. Outpatient individuals with schizophrenia receiving treatment will be randomly assigned to AE training or Treatment As Usual (TAU). Participants in the AE training will undergo a 12-week, 3 times per week, 1-hour AE sessions. All participants will continue their regular psychiatric and medical care. Assessments of neurocognitive and daily functioning abilities, along with symptom severity, and physiological and behavioral measures of aerobic fitness will be completed before and after the 12-week program.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Males and females between ages 18-55.
• Have capacity to give informed consent.
• English speaking.
• Have a DSM-IV diagnosis of schizophrenia.
• Taking antipsychotic medication for at least 8 weeks and on current doses for 4 weeks, and/or injectable depot antipsychotics with no change in last 3 months.
• Medically cleared to exercise.

Exclusion Criteria

• Lacks capacity to give informed consent.
• Have used street drugs within the past 4 weeks.
• Have history of of hypertension of cardiac conditions.
• Have history of active suicidal ideation or serious self-destructive behavior.
• Have history of violence or aggressive behavior.
• Have history of neurological or medical conditions known to seriously affect the brain.
• Pregnant or nursing.
• Completing more than 2 hours of moderate or higher levels of aerobic exercise per week.
• Participation in a study of cognition during the previous 2 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Psychiatric Treatment	Standard Psychiatric Treatment	12 weeks of standard psychiatric treatment.
Aerobic Exercise	Aerobic Exercise	Up to 36 sessions of aerobic exercise (12 weeks of 3 times/week, 60-minute exercise sessions) in small groups (3-5 individuals), in addition to standard psychiatric treatment.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Daily Functioning Assessments at 12 weeks	Baseline and after 12 weeks	Measures include: The Specific Levels of Functioning Scale (SLOF), Quality of Life Scale (QLS), and Quality of Life Scale (QoL-16).
Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks	Baseline and after 12 weeks	The VO2Max (maximal oxygen consumption) test measures maximum ability to consume oxygen and is a key indicator of aerobic fitness.
Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks	Baseline and after 12 weeks.	Standardized battery designed to measure cognition specifically in individuals in schizophrenia.
Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks	Baseline and after 12 weeks	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in The Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia program (CNTRICS) measures at 12 weeks	Baseline and after 12 weeks	Measures include: AX-CPT/Dot Pattern Expectancy (DPX) Task, Recent Probe Task, Relational Item Specific Encoding Task, Probabilistic Reward Task, Sustained Attention Task with and without Distraction, Automated Operation Span Task (OSPAN), and Automated Symmetry Span Task (SSPAN).

Trial Locations

Locations (1)

Columbia University & New York State Psyciatric Institute; 🇺🇸 New York, New York, United States