Trial Outcomes & Findings for Aerobic Exercise for Cognition in Schizophrenia (NCT NCT02621983)

NCT ID: NCT02621983

Last Updated: 2019-10-23

Results Overview

Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2019-10-23

Participant Flow

There is a discrepancy between the enrollment number (50) and the participant flow module (38) because 12 participants either failed the initial screening procedures or were unable to be randomized because they didn't complete the baseline visit prior to randomization.

Participant milestones

Participant milestones
Measure	Aerobic Exercise Subjects with a diagnosis of schizophrenia (SCZ) will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Balance and Stretching Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Overall Study STARTED	21	17
Overall Study COMPLETED	9	6
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One individual did not complete the 400m walk because of obstacles on the course. Individual then dropped out of the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerobic Exercise n=21 Participants Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Balance and Stretching n=17 Participants Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=21 Participants	0 Participants n=17 Participants	0 Participants n=38 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=21 Participants	17 Participants n=17 Participants	38 Participants n=38 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants	0 Participants n=17 Participants	0 Participants n=38 Participants
Age, Continuous	52.524 years STANDARD_DEVIATION 6.660 • n=21 Participants	53.176 years STANDARD_DEVIATION 10.273 • n=17 Participants	52.816 years STANDARD_DEVIATION 8.239 • n=38 Participants
Sex: Female, Male Female	5 Participants n=21 Participants	2 Participants n=17 Participants	7 Participants n=38 Participants
Sex: Female, Male Male	16 Participants n=21 Participants	15 Participants n=17 Participants	31 Participants n=38 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants	0 Participants n=17 Participants	0 Participants n=38 Participants
Race (NIH/OMB) Asian	0 Participants n=21 Participants	0 Participants n=17 Participants	0 Participants n=38 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants	0 Participants n=17 Participants	0 Participants n=38 Participants
Race (NIH/OMB) Black or African American	19 Participants n=21 Participants	17 Participants n=17 Participants	36 Participants n=38 Participants
Race (NIH/OMB) White	2 Participants n=21 Participants	0 Participants n=17 Participants	2 Participants n=38 Participants
Race (NIH/OMB) More than one race	0 Participants n=21 Participants	0 Participants n=17 Participants	0 Participants n=38 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants	0 Participants n=17 Participants	0 Participants n=38 Participants
Region of Enrollment United States	21 participants n=21 Participants	17 participants n=17 Participants	38 participants n=38 Participants
400m Walk Time	358.95 seconds STANDARD_DEVIATION 58.022 • n=21 Participants • One individual did not complete the 400m walk because of obstacles on the course. Individual then dropped out of the study.	345.38 seconds STANDARD_DEVIATION 57.218 • n=16 Participants • One individual did not complete the 400m walk because of obstacles on the course. Individual then dropped out of the study.	353.08 seconds STANDARD_DEVIATION 57.279 • n=37 Participants • One individual did not complete the 400m walk because of obstacles on the course. Individual then dropped out of the study.

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: We had significant drop-out during the course of the 12 week exercise paradigm, therefore only 11 from the Aerobic group and 6 from the Balance and Stretching group completed all 12 weeks worth of exercise.

Outcome measures

Outcome measures
Measure	Aerobic Exercise n=11 Participants Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Balance and Stretching n=6 Participants Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Baseline	24.909 T-score Standard Deviation 9.332	31.333 T-score Standard Deviation 5.989
Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) 12 Weeks	27.727 T-score Standard Deviation 10.258	32.833 T-score Standard Deviation 6.113

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: We had many individuals who dropped out during the course of the 12 week exercise program, this leads to the discrepancy in number of participants analyzed when compared to those who were randomized into the two arms of the study.

Functional ability will be assessed using the University of California San Diego Performance-Based skills assessment (UPSA). The UPSA is a measure of functional ability to perform common activities of daily living. It assess communication, financial, and household skills as well as the ability to manage medication, navigate transportation, and organize and plan an activity. Each measure creates a raw score which is summed to create a composite score. A higher score indicates better functional ability. No clinically significant thresholds. The maximum score an individual could obtain was 87 and the minimum was 0. The score is reported on scale units.

Outcome measures

Outcome measures
Measure	Aerobic Exercise n=11 Participants Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Balance and Stretching n=6 Participants Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Change in Functional Ability Baseline	58.55 units on a scale Standard Deviation 13.46	67.83 units on a scale Standard Deviation 5.42
Change in Functional Ability Week 12	60.64 units on a scale Standard Deviation 9.89	64.16 units on a scale Standard Deviation 9.28

SECONDARY outcome

Timeframe: Baseline, 20 weeks

Population: We had significant drop out from baseline measurement to week 20, accounting for the difference in numbers when compared to the total enrolled. We also had two drop out in the Aerobic Exercise group between week 12 and week 20 accounting, which explains the difference in number between the primary outcome and this outcome.

Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores.

Outcome measures

Outcome measures
Measure	Aerobic Exercise n=9 Participants Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Balance and Stretching n=6 Participants Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Change in MCCB Scores Baseline	24.78 T-score Standard Deviation 7.95	31.33 T-score Standard Deviation 5.99
Change in MCCB Scores Week 20	29.33 T-score Standard Deviation 8.12	29.5 T-score Standard Deviation 7.64

SECONDARY outcome

Timeframe: Baseline, 20 weeks

Population: The numbers will differ from the initial secondary outcome because we had two individuals drop out of the study between the week 12 and week 20 assessments.

Outcome measures

Outcome measures
Measure	Aerobic Exercise n=9 Participants Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Balance and Stretching n=6 Participants Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA) Baseline	57.66 units on a scale Standard Deviation 14.11	67.83 units on a scale Standard Deviation 5.42
Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA) Week 20	64.33 units on a scale Standard Deviation 7.60	67.33 units on a scale Standard Deviation 8.21

Adverse Events

Aerobic Exercise

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Balance and Stretching

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aerobic Exercise n=21 participants at risk Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Balance and Stretching n=17 participants at risk Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Psychiatric disorders Psychiatric Admission	9.5% 2/21 • Number of events 2 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.	0.00% 0/17 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.
Cardiac disorders Hospital Admission	0.00% 0/21 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.	5.9% 1/17 • Number of events 1 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.
Cardiac disorders Adverse Medication Reaction	4.8% 1/21 • Number of events 1 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.	0.00% 0/17 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.

Other adverse events

Other adverse events
Measure	Aerobic Exercise n=21 participants at risk Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Aerobic Exercise: Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.	Balance and Stretching n=17 participants at risk Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks. Balance and Stretching: Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
Social circumstances Car Accident	4.8% 1/21 • Number of events 1 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.	0.00% 0/17 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.
Psychiatric disorders Claustrophobia	0.00% 0/21 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.	5.9% 1/17 • Number of events 1 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.
Musculoskeletal and connective tissue disorders Muscle fatigue and pain	4.8% 1/21 • Number of events 1 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.	5.9% 1/17 • Number of events 1 • Adverse event data was collected while the subject was enrolled in the study, at most a total of 5 months.

Additional Information

Dr. Erica Duncan

Atlanta VA Medical Center

Phone: 404-321-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place