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| ID | Type | Description | Link |
|---|---|---|---|
| 1I21RX002026 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical exercise | Experimental | Participants participate in brisk walking exercises. |
|
| Stretching exercise | Active Comparator | Participants participate in non-aerobic, non-Yoga stretching exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Behavioral | Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S. Kern, PhD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23873090 | Background | Malchow B, Reich-Erkelenz D, Oertel-Knochel 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. | |
| 22120173 | Background | 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. |
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De-identified individual data will be made available.
The study protocol and SAP will be available one year after study completion and will be available indefinitely.
The study protocol and SAP will be available to the public domain.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Exercise | Participants participate in brisk walking exercises. Physical exercise: Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, 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). |
| FG001 | Stretching Exercise | Participants participate in non-aerobic, non-Yoga stretching exercises Stretching exercise: Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Exercise | Participants participate in brisk walking exercises. Physical exercise: Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ml.kg-1.min-1 | Change from baseline to 12-week endpoint assessment |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Exercise | Participants participate in brisk walking exercises. Physical exercise: Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Kern | VA Greater Los Angeles Healthcare System | 310-478-3711 | 49229 | Robert.Kern2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2019 | Aug 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Stretching exercise | Behavioral | Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week. |
|
| Change from baseline to the 12-week endpoint assessment |
| 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 |
| 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 |
| Change from baseline to the 12-week endpoint assessment |
| 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 |
| 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 |
| 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 |
| 25805886 | Background | 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. |
| 25400592 | Background | 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. |
| 20124113 | Background | 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. |
| BG001 | Stretching Exercise | Participants participate in non-aerobic, non-Yoga stretching exercises Stretching exercise: Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Participants were all Veterans. | Number | participants |
|
| VO2max | Mean | Standard Deviation | ml.kg-1.min-1 |
|
| Birchwood Social Functioning Scale | Birchwood Social Functioning Scale - This scale is a measure of social functioning that includes seven domains (social engagement, interpersonal communication, independence - performance, independence - competence, recreation, prosocial behavior, and employment). The subscale scores are summed to yield a total score. The primary outcome measure is a total score with a possible range from 0 to 223; higher scores represent better social functioning. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Stretching Exercise | Participants participate in non-aerobic, non-Yoga stretching exercises Stretching exercise: Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 12 week endpoint assessment |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 12-week endpoint assessment |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to the 12-week endpoint assessment |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to the 12-week endpoint assessment |
|
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| 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. | Posted | Mean | Standard Deviation | z-score | Change from baseline to the 12-week endpoint assessment |
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| 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. | Posted | Mean | Standard Deviation | z-score | Change from baseline to the 12-week endpoint assessment |
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| Secondary | BDNF Value | BDNF concentration will be quantified by enzyme-linked immunosorbent assay (R&D Systems). The value will be expressed in ng/ml. | Posted | Mean | Standard Deviation | ng/ml | Change from baseline to the 12-week endpoint assessment |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to the 12-week endpoint assessment |
|
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|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to the 12-week endpoint assessment |
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|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Stretching Exercise | Participants participate in non-aerobic, non-Yoga stretching exercises Stretching exercise: Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| ANCOVA |
The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate. |
| .33 |
For cohort 3, positive affect was measured at baseline and a midpoint assessment. |
| Effect size |
| 0.73 |
| 2-Sided |
| Superiority |
| ANCOVA |
The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate. |
| .23 |
For cohort 3, positive affect was measured at a baseline and midpoint assessment. |
| Effect size |
| 0.77 |
| 2-Sided |
| Superiority |