Aerobic Exercise for Cognition in Schizophrenia

NCT02621983 | Completed Results DMC

• 3 other identifiers: D1897-P1I21RX001897-01A1IRB00082701
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the ability of aerobic exercise (AE) to improve cognition in people with schizophrenia. Participants will be randomly assigned to one of two interventions: (1) aerobic exercise class (stationary bicycle, or "spin" class) for up to 45 minutes three times per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three times per week for 12 weeks.

Conditions

Schizophrenia

Keywords

Schizophrenia; Exercise; Cognition

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

  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.

  Baseline, 12 weeks

Secondary Outcomes (3)

• Change in Functional Ability

  Baseline, 12 weeks

• Change in MCCB Scores

  Baseline, 20 weeks

• Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA)

  Baseline, 20 weeks

Study Arms (2)

Aerobic Exercise

ACTIVE COMPARATOR

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.

Behavioral: Aerobic Exercise

Balance and Stretching

ACTIVE COMPARATOR

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.

Behavioral: Balance and Stretching

Interventions

Aerobic Exercise BEHAVIORAL

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

Balance and Stretching BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia or schizoaffective disorder
• maintained on stable doses of outpatient psychiatric medications for at least 30 days
• compliant with outpatient follow-up
• have a stable place to live
• access to transportation to the hospital
• doing less than 20 minutes per week of regular physical activity in the past month

You may not qualify if:

• Bipolar disorder;
• active substance dependence within the prior 30 days
• more than 2 psychiatric admissions within the prior six months
• known HIV infection or AIDS
• history of traumatic brain injury
• current seizure disorder
• Alzheimer's disease or other dementia
• clinical history of mild cognitive impairment
• Parkinson's disease
• other current clinically significant neurological disease
• unstable medical condition that would be expected to interfere with fitness training
• significant hearing or visual impairment

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Emory University: collaborator

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Schizophrenia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Erica Duncan
• Organization: Atlanta VA Medical Center

erica.duncan@va.gov

404-321-6111

Study Officials

• Erica J. Duncan, MD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)