The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

Schizophrenia Clinical Trial

Official title:

The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897064
• Other study ID #: 6508
• Secondary ID: R21 096132
• Status: Completed
• Phase: N/A
• First received: June 26, 2013
• Last updated: August 14, 2014
• Start date: April 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Aerobic Exercise
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 care.

Other:
• Standard Psychiatric Treatment
Standard psychiatric treatment.

Locations

Country	Name	City	State
United States	Columbia University & New York State Psyciatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks	Standardized battery designed to measure cognition specifically in individuals in schizophrenia.	Baseline and after 12 weeks.	No
Primary	Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks	The VO2Max (maximal oxygen consumption) test measures maximum ability to consume oxygen and is a key indicator of aerobic fitness.	Baseline and after 12 weeks	No
Primary	Change from Baseline in 6-Minute Walk Test (6MWT) score at 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.	Baseline and after 12 weeks	No
Primary	Change from Baseline in Daily Functioning Assessments at 12 weeks	Measures include: The Specific Levels of Functioning Scale (SLOF), Quality of Life Scale (QLS), and Quality of Life Scale (QoL-16).	Baseline and after 12 weeks	No
Secondary	Change from Baseline in The Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia program (CNTRICS) measures at 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).	Baseline and after 12 weeks	No