Trial Outcomes & Findings for Benefits of Physical Exercise in Schizophrenia (NCT NCT02716584)
NCT ID: NCT02716584
Last Updated: 2019-09-19
Results Overview
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.
COMPLETED
NA
53 participants
Change from baseline to 12-week endpoint assessment
2019-09-19
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
18
|
|
Overall Study
COMPLETED
|
27
|
13
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
Baseline Characteristics
Benefits of Physical Exercise in Schizophrenia
Baseline characteristics by cohort
| Measure |
Physical Exercise
n=35 Participants
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).
|
Stretching Exercise
n=18 Participants
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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
18 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
VO2max
|
22.6 ml.kg-1.min-1
STANDARD_DEVIATION 15.3 • n=5 Participants
|
23.3 ml.kg-1.min-1
STANDARD_DEVIATION 12.4 • n=7 Participants
|
22.8 ml.kg-1.min-1
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Birchwood Social Functioning Scale
|
121.0 units on a scale
STANDARD_DEVIATION 24.7 • n=5 Participants
|
116.7 units on a scale
STANDARD_DEVIATION 22.1 • n=7 Participants
|
119.5 units on a scale
STANDARD_DEVIATION 23.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 12-week endpoint assessmentMeasure 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
VO2max
|
4.0 ml.kg-1.min-1
Standard Deviation 4.0
|
0.2 ml.kg-1.min-1
Standard Deviation 5.6
|
PRIMARY outcome
Timeframe: Change from baseline to 12 week endpoint assessmentBirchwood 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
Total Score for Social Functioning
|
3.7 score on a scale
Standard Deviation 10.9
|
-2.5 score on a scale
Standard Deviation 10.2
|
PRIMARY outcome
Timeframe: Change from baseline to 12-week endpoint assessmentBrief 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
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 score on a scale
Standard Deviation 4.9
|
2.3 score on a scale
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: Change from baseline to the 12-week endpoint assessmentPositive 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
Total Score for Positive Affect as Assessed by the Positive and Negative Affect Scale (PANAS)
|
-5.6 score on a scale
Standard Deviation 12.6
|
-8.9 score on a scale
Standard Deviation 14.1
|
PRIMARY outcome
Timeframe: Change from baseline to the 12-week endpoint assessmentPositive 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
Total Score for Negative Affect as Assessed by the Positive and Negative Affect Scale (PANAS)
|
3.8 score on a scale
Standard Deviation 8.8
|
2.6 score on a scale
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: Change from baseline to the 12-week endpoint assessmentRaw 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
Composite Score From Non-social Cognition Battery
|
.01 z-score
Standard Deviation .50
|
.06 z-score
Standard Deviation .52
|
SECONDARY outcome
Timeframe: Change from baseline to the 12-week endpoint assessmentRaw 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
Composite Score From Social Cognition Battery
|
.06 z-score
Standard Deviation .46
|
-.17 z-score
Standard Deviation .47
|
SECONDARY outcome
Timeframe: Change from baseline to the 12-week endpoint assessmentBDNF concentration will be quantified by enzyme-linked immunosorbent assay (R\&D Systems). The value will be expressed in ng/ml.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
BDNF Value
|
-1.04 ng/ml
Standard Deviation 9.57
|
-7.31 ng/ml
Standard Deviation 8.01
|
SECONDARY outcome
Timeframe: Change from baseline to the 12-week endpoint assessmentThe 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
Positive Symptom Subscale Score From the BPRS
|
-1.2 score on a scale
Standard Deviation 4.5
|
-1.2 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Change from baseline to the 12-week endpoint assessmentThe 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.
Outcome measures
| Measure |
Physical Exercise
n=27 Participants
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).
|
Stretching Exercise
n=13 Participants
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.
|
|---|---|---|
|
Negative Symptom Subscale Score From the BPRS
|
0.1 score on a scale
Standard Deviation 2.5
|
0.1 score on a scale
Standard Deviation 2.8
|
Adverse Events
Physical Exercise
Stretching Exercise
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Kern
VA Greater Los Angeles Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place