The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

August 14, 2014 updated by: New York State Psychiatric Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University & New York State Psyciatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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 Names:
  • AE
ACTIVE_COMPARATOR: Standard Psychiatric Treatment
12 weeks of standard psychiatric treatment.
Other: Standard Psychiatric Treatment
Standard psychiatric treatment.
Other Names:
  • Treatment As Usual (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks
Time Frame: Baseline and after 12 weeks.
Standardized battery designed to measure cognition specifically in individuals in schizophrenia.
Baseline and after 12 weeks.
Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks
Time Frame: 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.
Baseline and after 12 weeks
Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks
Time Frame: 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.
Baseline and after 12 weeks
Change from Baseline in Daily Functioning Assessments at 12 weeks
Time Frame: 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).
Baseline and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in The Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia program (CNTRICS) measures at 12 weeks
Time Frame: 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).
Baseline and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David Kimhy, Ph.D., Columbia University & New York State Psyciatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (ESTIMATE)

July 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6508
  • R21 096132 (OTHER_GRANT: NIMH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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