Schizophrenia Clinical Trial
Official title:
Physical Exercise Effects on Determinants of Social Integration in Schizophrenia
Verified date | August 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | July 12, 2018 |
Est. primary completion date | July 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Heggelund J, Kleppe KD, Morken G, Vedul-Kjelsås 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. — View Citation
Kimhy D, Vakhrusheva J, Bartels MN, Armstrong HF, Ballon JS, Khan S, Chang RW, Hansen MC, Ayanruoh L, Lister A, Castrén 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. — View Citation
Knöchel C, Oertel-Knöchel 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. Review. — View Citation
Malchow B, Reich-Erkelenz D, Oertel-Knöchel V, Keller K, Hasan A, Schmitt A, Scheewe TW, Cahn W, Kahn RS, Falkai P. The effects of physical exercise in schizophrenia and affective disorders. Eur Arch Psychiatry Clin Neurosci. 2013 Sep;263(6):451-67. doi: 10.1007/s00406-013-0423-2. Epub 2013 Jul 20. Review. — View Citation
Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Müller 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VO2max | Measure of aerobic capacity (VO2max) is derived by using a regression formula based on age, weight, sex, and time to complete walking of one mile. Because scores are derived using a regression equation, there is no absolute minimum or maximum value; higher scores represent better aerobic capacity. | Change from baseline to 12-week endpoint assessment | |
Primary | Total Score for Social Functioning | Birchwood Social Functioning Scale is a measure of social functioning. The total score for social functioning is calculated by summing the raw scores from each of the seven subscales (social engagement, interpersonal communication, independence - performance, independence - competence, recreation, prosocial behavior, employment); possible range is 0 to 223 with higher scores representing better social functioning. | Change from baseline to 12 week endpoint assessment | |
Primary | Total Score for Speed of Processing (i.e., Cognition) as Assessed by the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Test | Brief Assessment of Cognition in Schizophrenia (BACS) is a measure of speed of information processing. The total score for speed of processing (i.e., cognition) is calculated by summing the number of symbol-code pairs completed correctly on the BACS Symbol Coding test within the allotted 90 second time limit. Scores range from 0 to 110 with higher scores representing better information processing speed. | Change from baseline to 12-week endpoint assessment | |
Primary | Total Score for Positive Affect as Assessed by the Positive and Negative Affect Scale (PANAS) | Positive and Negative Affect Scale is a measure of an individual's positive and negative affect. The scale includes 32 items; 16 denote positive affect and 16 denote negative affect. Each item is rated on a scale of 1 (very slightly or not at all) to 5 (extremely). The total score for PANAS positive affect is calculated by summing the ratings for items denoting positive affect. Scores range from 16 to 80; higher scores represent better positive affect. | Change from baseline to the 12-week endpoint assessment | |
Primary | Total Score for Negative Affect as Assessed by the Positive and Negative Affect Scale (PANAS) | Positive and Negative Affect Scale is a measure of an individual's positive and negative affect. The scale includes 32 items; 16 denote positive affect and 16 denote negative affect. Each item is rated on a scale of 1 (very slightly or not at all) to 5 (extremely). The total score for PANAS negative affect is calculated by summing the ratings for items denoting negative affect. Scores range from 16 to 80; lower scores represent better levels of negative affect. | Change from baseline to the 12-week endpoint assessment | |
Primary | Composite Score From Non-social Cognition Battery | Raw scores (i.e., total scores) for the following tests will be transformed to z-scores: attention (CPT-IP), speed of processing (BACS symbol coding), working memory (WAIS-IV letter-number sequencing test), verbal learning (Hopkins Verbal Learning Test - Revised), and executive control (AX-CPT). The outcome measure is the mean z-score. The composite z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean of the overall sample of study participants. Negative numbers indicate values lower than other study participants and positive numbers indicate values higher than other study participants. | Change from baseline to the 12-week endpoint assessment | |
Secondary | Composite Score From Social Cognition Battery | Raw scores (i.e., total scores) for the following tests will be transformed to z-scores: emotion perception (Facial Emotion Identification Test), social perception (Half-Profile of Nonverbal Sensitivity; PONS), theory of mind (The Awareness of Social Inference Test; TASIT - Part 2), empathy (empathic accuracy test). The outcome measure is the mean z-score. The composite z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean of the overall sample of study participants. Negative numbers indicate values lower than other study participants and positive numbers indicate values higher than other study participants. | Change from baseline to the 12-week endpoint assessment | |
Secondary | BDNF Value | BDNF concentration will be quantified by enzyme-linked immunosorbent assay (R&D Systems). The value will be expressed in ng/ml. | Change from baseline to the 12-week endpoint assessment | |
Secondary | Positive Symptom Subscale Score From the BPRS | The Brief Psychiatric Rating Scale (BPRS) is a measure of psychiatric symptom severity and includes subscale scores for positive and negative symptoms. The outcome score for positive symptoms is calculated by summing the ratings for items measuring hallucinations, unusual thought content, and conceptual disorganization; each item is rated on a scale of 1 to 7 with higher scores indicating greater symptom severity; possible range for positive symptoms is 0 to 21 with higher scores representing greater severity of positive symptoms. | Change from baseline to the 12-week endpoint assessment | |
Secondary | Negative Symptom Subscale Score From the BPRS | The Brief Psychiatric Rating Scale (BPRS) is a measure of psychiatric symptom severity and includes subscale scores for positive and negative symptoms. The outcome score for negative symptoms is calculated by summing the ratings for items measuring blunted affect, emotional withdrawal, and motor retardation; each item is rated on a scale of 1 to 7 with higher scores indicating greater symptom severity; possible range for negative symptoms is 0 to 21 with higher scores representing greater severity of negative symptoms. | Change from baseline to the 12-week endpoint assessment |
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