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Benefits of Physical Exercise in Schizophrenia

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VA Office of Research and Development

Status

Completed

Conditions

Schizophrenia

Treatments

Behavioral: Stretching exercise
Behavioral: Physical exercise

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02716584
1I21RX002026 (U.S. NIH Grant/Contract)
D2026-P

Details and patient eligibility

About

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.

Full description

Difficulties in social integration pose a major mental health problem for Veterans with schizophrenia. Reviews of the literature indicate that Veterans with schizophrenia have lower marriage rates, fewer friendships, and higher rates of living alone than the general population. Poor social integration is also associated with early mortality. To gain traction on this problem, it will be necessary to find treatments that address key determinants of social integration. Evidence indicates that impairments in cognition and affect are among the key determinants of this area of functioning. Findings from the broader rehabilitation literature support a novel conceptual approach to this problem, namely engagement in physical exercise. Physical exercise is associated with improvements in attention, episodic memory, working memory, speed of processing, and executive control. In addition, physical exercise is associated with increases in positive affect and decreases in negative affect. Findings on the effects of physical exercise on cognition and affect have been reported for normal aging, mild cognitive impairment, neurodegenerative disorders, oncology, and depression, but is an area of investigation relatively new to schizophrenia. The proposed study will include 54 Veterans with schizophrenia or schizoaffective disorder (aged 45-65) who will be matched on baseline levels of cardiorespiratory fitness, and then randomized (2:1) to a walking exercise group (n=36) or a control comparison group (n=18). Veterans in the exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups (n=6), held 3 times per week, gradually increasing walking time until reaching a maximum of 40-minutes per session. The heart rate of each Veteran will be monitored during the walking sessions to help ensure maintenance of a target peak heart rate of 60% to 70% of the maximum for the individual's age (i.e., 220-age). Veterans in the control group will participate in instructor-led, non-aerobic stretching exercises in small groups (n=6) with the duration, frequency, and total number of sessions matched to the exercise group. Primary outcome measures of cardiorespiratory fitness, cognition, and positive and negative affect of participants in both groups will be measured at baseline and the 12-week end-point assessment.

Enrollment

53 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

53 participants in 2 patient groups

Physical exercise
Experimental group
Description:
Participants participate in brisk walking exercises.
Treatment:
Behavioral: Physical exercise
Stretching exercise
Active Comparator group
Description:
Participants participate in non-aerobic, non-Yoga stretching exercises
Treatment:
Behavioral: Stretching exercise

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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