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The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Standard Psychiatric Treatment
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognition, Aerobic Exercise

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbia University & New York State Psyciatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Exercise

Standard Psychiatric Treatment

Arm Description

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.

12 weeks of standard psychiatric treatment.

Outcomes

Primary Outcome Measures

Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks
Standardized battery designed to measure cognition specifically in individuals in schizophrenia.
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.
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.
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).

Secondary Outcome Measures

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).

Full Information

First Posted
June 26, 2013
Last Updated
August 14, 2014
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01897064
Brief Title
The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.
Official Title
The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Cognition, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Psychiatric Treatment
Arm Type
Active Comparator
Arm Description
12 weeks of standard psychiatric treatment.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Other Intervention Name(s)
AE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Psychiatric Treatment
Other Intervention Name(s)
Treatment As Usual (TAU)
Intervention Description
Standard psychiatric treatment.
Primary Outcome Measure Information:
Title
Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks
Description
Standardized battery designed to measure cognition specifically in individuals in schizophrenia.
Time Frame
Baseline and after 12 weeks.
Title
Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks
Description
The VO2Max (maximal oxygen consumption) test measures maximum ability to consume oxygen and is a key indicator of aerobic fitness.
Time Frame
Baseline and after 12 weeks
Title
Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change from Baseline in Daily Functioning Assessments at 12 weeks
Description
Measures include: The Specific Levels of Functioning Scale (SLOF), Quality of Life Scale (QLS), and Quality of Life Scale (QoL-16).
Time Frame
Baseline and after 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in The Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia program (CNTRICS) measures at 12 weeks
Description
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).
Time Frame
Baseline and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kimhy, Ph.D.
Organizational Affiliation
Columbia University & New York State Psyciatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University & New York State Psyciatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26423100
Citation
Kimhy D, Khan S, Ayanrouh L, Chang RW, Hansen MC, Lister A, Ballon JS, Vakhrusheva J, Armstrong HF, Bartels MN, Sloan RP. Use of Active-Play Video Games to Enhance Aerobic Fitness in Schizophrenia: Feasibility, Safety, and Adherence. Psychiatr Serv. 2016 Feb;67(2):240-3. doi: 10.1176/appi.ps.201400523. Epub 2015 Oct 1.
Results Reference
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The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

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