Clinical trial NCT02716584: Benefits of Physical Exercise in Schizophrenia
Official title: Physical Exercise Effects on Determinants of Social Integration in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-03-23
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: VO2max
timeFrame: Change from baseline to 12-week endpoint assessment
measure: Total Score for Social Functioning
timeFrame: Change from baseline to 12 week endpoint assessment
measure: Total Score for Speed of Processing (i.e., Cognition) as Assessed by the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Test
timeFrame: Change from baseline to 12-week endpoint assessment
measure: Total Score for Positive Affect as Assessed by the Positive and Negative Affect Scale (PANAS)
timeFrame: Change from baseline to the 12-week endpoint assessment
measure: Total Score for Negative Affect as Assessed by the Positive and Negative Affect Scale (PANAS)
timeFrame: Change from baseline to the 12-week endpoint assessment
measure: Composite Score From Non-social Cognition Battery
timeFrame: Change from baseline to the 12-week endpoint assessment
Secondary outcomes:
measure: Composite Score From Social Cognition Battery
timeFrame: Change from baseline to the 12-week endpoint assessment
measure: BDNF Value
timeFrame: Change from baseline to the 12-week endpoint assessment
measure: Positive Symptom Subscale Score From the BPRS
timeFrame: Change from baseline to the 12-week endpoint assessment
measure: Negative Symptom Subscale Score From the BPRS
timeFrame: Change from baseline to the 12-week endpoint assessment
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Robert S. Kern, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Knochel C, Oertel-Knochel V, O'Dwyer L, Prvulovic D, Alves G, Kollmann B, Hampel H. Cognitive and behavioural effects of physical exercise in psychiatric patients. Prog Neurobiol. 2012 Jan;96(1):46-68. doi: 10.1016/j.pneurobio.2011.11.007. Epub 2011 Nov 24.
citation: Kimhy D, Vakhrusheva J, Bartels MN, Armstrong HF, Ballon JS, Khan S, Chang RW, Hansen MC, Ayanruoh L, Lister A, Castren E, Smith EE, Sloan RP. The Impact of Aerobic Exercise on Brain-Derived Neurotrophic Factor and Neurocognition in Individuals With Schizophrenia: A Single-Blind, Randomized Clinical Trial. Schizophr Bull. 2015 Jul;41(4):859-68. doi: 10.1093/schbul/sbv022. Epub 2015 Mar 23.
citation: Heggelund J, Kleppe KD, Morken G, Vedul-Kjelsas E. High aerobic intensity training and psychological States in patients with depression or schizophrenia. Front Psychiatry. 2014 Oct 30;5:148. doi: 10.3389/fpsyt.2014.00148. eCollection 2014.
citation: Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193.