The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

NCT ID: NCT01897064

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-07-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: 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.

Standard Psychiatric Treatment

12 weeks of standard psychiatric treatment.

Group Type: ACTIVE_COMPARATOR

Standard Psychiatric Treatment

Intervention Type: OTHER

Standard psychiatric treatment.

Interventions

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.

Intervention Type: BEHAVIORAL

Standard Psychiatric Treatment

Standard psychiatric treatment.

Intervention Type: OTHER

Other Intervention Names

AE; Treatment As Usual (TAU)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kimhy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University & New York State Psyciatric Institute

Locations

Columbia University & New York State Psyciatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26423100 (View on PubMed)

Other Identifiers

R21 096132

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

6508

Identifier Type: -

Identifier Source: org_study_id