Improving Cognition Via Exercise in Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03270098|
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia and Related Disorders||Behavioral: Aerobic Exercise Behavioral: Stretching and Toning Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is a single-blind, parallel assignment, multi-site randomized clinical trial designed to examine the impact of exercise on cognition, daily functioning, and biomarkers of cognitive change in people with schizophrenia.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Cognition Via Exercise in Schizophrenia|
|Actual Study Start Date :||April 26, 2018|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Aerobic Exercise
using traditional exercise equipment (i.e., treadmill, stationary bike) along with active-play video games (Xbox Kinect).
Behavioral: Aerobic Exercise
Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.
|Active Comparator: Stretching and Toning Exercise||
Behavioral: Stretching and Toning Exercise
Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.
- Change in the MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline and 12 weeks ]The MCCB is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. Change in the MCCB at 12 weeks as compared to baseline.
- Change in VO2Max [ Time Frame: Baseline and 12 weeks ]VO2Max (maximal oxygen consumption) is an index of the ability to consume oxygen and is a key indicator of aerobic fitness. Change in the VO2Max at 12 weeks as compared to baseline.
- Change in the Specific Levels of Functioning Scale (SLOF) [ Time Frame: Baseline and 12 weeks ]The SLOF is a 43-item survey assessing multiple domains of daily functioning. Total score range from 43 to 215, with higher scores indicating better the overall functioning. Change in the SLOF at 12 weeks as compared to baseline.
- Change in the UCSD Performance-based Skills Assessment (UPSA) [ Time Frame: Baseline and 12 weeks ]The UPSA is performance-based measure of real-world daily functioning abilities. Participants receive scores for multiple domains, which are summed to create a summary score ranging from 0 to 100 with higher score indicating better overall functioning. Change in the UPSA at 12 weeks as compared to baseline.
- Change in the Schizophrenia Cognition Rating Scale (SCoRS) [ Time Frame: Baseline and 12 weeks ]The SCoRS is a 20-item clinician-administered interview assessing cognition-related daily functioning. Each item rated on a 4-point scale ranging from "no impairment" to "severe impairment". Total scores range from 20-80, with higher score indicating poorer functioning. Change in the SCoRS at 12 weeks as compared to baseline.
- Serum BDNF [ Time Frame: Baseline and 12 weeks ]BDNF is extracted from blood samples and serves as a biomarker of exercise-related cognitive changes. Change in the BDNF at 12 weeks as compared to baseline.
- Change in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline and 12 weeks ]The C-SSRS is a semi-structured interview that measures 4 suicide risk related domains: ideation severity, ideation intensity, behavior, and lethality. Full scale from 1-10, with higher score indicating more suicidal ideation and behavior. Change in the C-SSRS at 12 weeks as compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270098
|Contact: David Kimhy, PhDemail@example.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Lauren Chang 650-498-8459 firstname.lastname@example.org|
|Contact: Daniel Virtheim (650) 353-7030 email@example.com|
|Principal Investigator: Jacob Ballon, MD, MPH|
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|Contact: Rebecca Nichols 706-721-4605 RNichols@augusta.edu|
|Principal Investigator: Joseph McEvoy, MD|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Luz Ospina, PhD 212-585-4647 firstname.lastname@example.org|
|Principal Investigator: David Kimhy, PhD|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Terry Edwards 919-445-0271 email@example.com|
|Principal Investigator: Fred Jarskog, MD|
|Principal Investigator:||David Kimhy, PhD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||T. Scott Stroup, MD, MPH||Columbia University|