The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

New York State Psychiatric Institute

Status: Completed

Conditions: Schizophrenia

Treatments: Other: Standard Psychiatric Treatment; Behavioral: Aerobic Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01897064

6508

R21 096132 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Aerobic Exercise

Experimental group

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.

Treatment:

Behavioral: Aerobic Exercise

Standard Psychiatric Treatment

Active Comparator group

Description:

12 weeks of standard psychiatric treatment.

Treatment:

Other: Standard Psychiatric Treatment