Skip to main content
OpenTrials
Completed

NCT Number: NCT01897064

The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University & New York State Psyciatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Behavioral

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

Standard Psychiatric Treatment

Other

Standard psychiatric treatment.

Other names: Treatment As Usual (TAU)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2013
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.