Aerobic Exercise for the Improvement of Cognition and Enhancement of Recovery in Post-acute Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-12-31

Brief Summary

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The study investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia.

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Detailed Description

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This multi-center, two-arm, parallel-group, randomized placebo-controlled add-on clinical trial investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia. The aim is the enhancement of recovery with the use of 26 weeks of continuos endurance training (aerobic exercise) with stationary bicycles or a balance and tone program consisting of exercises for flexibility, core strength, balance and relaxation. Followed by a follow-up period of 26 weeks.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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endurance training

endurance training with stationary bicycles

Group Type EXPERIMENTAL

endurance training

Intervention Type OTHER

endurance training with stationary bicycles

balance and tone program

flexibility, core strength, balance, relaxation

Group Type ACTIVE_COMPARATOR

balance and tone program

Intervention Type OTHER

flexibility, core strength, balance, relaxation

Interventions

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endurance training

endurance training with stationary bicycles

Intervention Type OTHER

balance and tone program

flexibility, core strength, balance, relaxation

Intervention Type OTHER

Other Intervention Names

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aerobic exercise

Eligibility Criteria

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Inclusion Criteria

* Informed consent given by the subject; DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90); age 18 to 65 years, male or female; PANSS at baseline: total score ≤ 75, proper contraception in female patients of childbearing potential; treatment with one or two antipsychotics in a stable dose of at least two weeks, body mass index between 18 and 40.

Exclusion Criteria

* Lack of accountability; positive urine drug-screening for illicit drugs at screening (except benzodiazepines); serious suicidal risk at screening visit; other relevant interferences of axis 1 according to diagnostic evaluation (MINI); other relevant neurological or other medical disorders; pregnancy or lactation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes