Aerobic Exercise
BehavioralTrainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.
NCT Number: NCT03270098
People with schizophrenia display a broad range of cognitive impairments that have been identified as major determinants of poor functioning and disability. Also, people with schizophrenia are at increased risk for suicide, with approximately 40-50% of individuals attempting to take their own lives during their lifetime. The goal of the proposed study is to examine the impact of remote exercise training on cognition, suicide risk, daily functioning, and biomarkers of cognitive change and suicidality in people with schizophrenia.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Stanford University, Stanford, California, United States
The goal of the proposed study is to examine the impact of remote exercise training on cognitive functioning in people with schizophrenia. People with schizophrenia display a broad range of cognitive impairments that have been identified as major determinants of poor functional outcome and disability, thus representing an important public health concern and a target for interventions. At present, available treatments offer only minimal to limited benefits to ameliorate these deficits. Extensive animal and human research literatures converge in supporting the positive influence of aerobic exercise training on cognitive functioning. Preliminary data indicate that aerobic exercise training is effective in improving cognitive functioning in people with schizophrenia. However, previous studies employed small samples, focused on a single or limited range of cognitive domains, and/or collected insufficient information on daily functioning or putative biomarkers underlying cognitive change. Supported by supplement funding from NIMH, the goal of the proposed study is also to explore the impact of remote exercise training on suicide risk in individuals with schizophrenia. People with schizophrenia are at increased risk for suicide, with approximately 40-50% of individuals attempting to take their own lives during their lifetime, and an estimated 5-10% actually being successful in completing suicide. This highly elevated risk represents a serious public health concern and an important target for interventions. However, available treatments offer only minimal to limited benefits to ameliorate this risk. Extensive animal and human research literatures converge in supporting the positive influence of AE training on a number of predictors of suicide risk including depressed mood, sleep difficulties, and poor cognition. Yet, at present there are no studies directly examining the impact of AE on suicide risk in this population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.
Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.
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.
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.
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.
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.
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.
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.
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.
Icahn School of Medicine at Mount Sinai
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07378150
Mental Disorders, Schizophrenia
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT06175559
Behavior, Gamification
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05169268
Anxiety Depression, Mental Disorders
Hong Kong
View Trial DetailsNCT06426134
Bipolar and Related Disorders, Depressive Episode
Amsterdam, North Holland, Netherlands
View Trial Details