The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.
2 other identifiers
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 15, 2014
August 1, 2014
2.2 years
June 26, 2013
August 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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
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
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
Secondary Outcomes (1)
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
Study Arms (2)
Aerobic Exercise
EXPERIMENTALUp 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.
Standard Psychiatric Treatment
ACTIVE COMPARATOR12 weeks of standard psychiatric treatment.
Interventions
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.
Standard psychiatric treatment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University & New York State Psyciatric Institute
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 26423100DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Kimhy, Ph.D.
Columbia University & New York State Psyciatric Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
July 11, 2013
Study Start
April 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 15, 2014
Record last verified: 2014-08