N/A N=53 Randomized Single-blind Treatment

Benefits of Physical Exercise in Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT02716584 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: VO2max — 4.0; 0.2 ml.kg-1.min-1 — p=0.02

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Physical exercise (Behavioral); Stretching exercise (Behavioral)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY VO2max	4.0; 0.2	0.02 sig
PRIMARY Total Score for Social Functioning	3.7; -2.5	0.06
PRIMARY Total Score for Speed of Processing (i.e., Cognition) as Assessed by the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Test	-0.4; 2.3	0.13
PRIMARY Total Score for Positive Affect as Assessed by the Positive and Negative Affect Scale (PANAS)	-5.6; -8.9	0.73
PRIMARY Total Score for Negative Affect as Assessed by the Positive and Negative Affect Scale (PANAS)	3.8; 2.6	0.62
PRIMARY Composite Score From Non-social Cognition Battery	.01; .06	0.57
SECONDARY Composite Score From Social Cognition Battery	.06; -.17	0.12
SECONDARY BDNF Value	-1.04; -7.31	0.07
SECONDARY Positive Symptom Subscale Score From the BPRS	-1.2; -1.2	0.88
SECONDARY Negative Symptom Subscale Score From the BPRS	0.1; 0.1	0.86

Summary

Impairments in social integration, characterized by low marriage rates, few friendships, and a high frequency of living alone, affect the vast majority of Veterans with schizophrenia. The primary aim of this proposal is to test the efficacy of a novel rehabilitation treatment approach, engaging in physical exercise, at improving two determinants of social integration which are impaired in schizophrenia: cognition and affect.

Eligibility Criteria

Inclusion Criteria

Diagnostic and Statistical Manual (DSM) - 5 diagnosis of schizophrenia or schizoaffective disorder;
age 40-65;
screened for physical health risks (i.e., no serious heart condition, dizziness, bone or joint problems posing safety concerns, ambulatory limitations);
clinically stable (e.g., no inpatient hospitalizations for 3 months prior to enrollment; no change in type of antipsychotic medication in the past 4 weeks)

Exclusion Criteria

evidence of alcohol or substance use disorder (moderate or greater severity) per DSM-5 criteria in the past 3 months;
clinically significant neurological disease as determined by medical history (e.g., seizure disorder);
history of serious head injury with loss of consciousness >1 hour;
participation in an exercise program within past 6 months;
not able to understand spoken and written English sufficiently to comprehend consent procedures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02716584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.