Clinical trial NCT01897064: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Cognition
Aerobic Exercise
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-07-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks
timeFrame: Baseline and after 12 weeks.
measure: Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks
timeFrame: Baseline and after 12 weeks
measure: Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks
timeFrame: Baseline and after 12 weeks
measure: Change from Baseline in Daily Functioning Assessments at 12 weeks
timeFrame: Baseline and after 12 weeks
Secondary outcomes:
measure: Change from Baseline in The Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia program (CNTRICS) measures at 12 weeks
timeFrame: Baseline and after 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University & New York State Psyciatric Institute
state: New York
Study officials:
affiliation: Columbia University & New York State Psyciatric Institute
name: David Kimhy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.