Exercise and Cognitive Training

NCT02326389 | Completed

• 1 other identifier: 3636
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the potential benefits of combining cognitive remediation and exercise in improving cognitive functioning and response to psychiatric rehabilitation.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Keywords

Cognitive functioning

Outcome Measures

Primary Outcomes (1)

• Composite Measure of Change in Neurocognitive functioning

  The neurocognitive outcome variables will be assessed at baseline, the week following the 10-week program, and 2 weeks later. Neurocognitive tests for primary outcome variables are from the MATRICS Neurocognition Committee for use with people with schizophrenia. These include tests of 1) attention and vigilance, 2) verbal working memory, 3) verbal learning, 4) visual learning, and 5) information processing speed.

  post- 10 week intervention and 2 weeks after end of intervention

Study Arms (2)

Exercise and Cognitive Remediation

EXPERIMENTAL

The exercise intervention is a 10-week program involving 40 minutes of aerobic exercise targeting 60-75% of maximum heart rate on 3 days each week, with an additional 5-minute stretching warm up and cool down. The experimental group will participate in the exercise intervention as well as cognitive remediation.

Behavioral: Exercise; Behavioral: Cognitive Remediation

Cognitive Remediation Only

ACTIVE COMPARATOR

Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies. One-hour sessions will be conducted 3 times per week for 10 weeks.

Behavioral: Cognitive Remediation

Interventions

Exercise BEHAVIORAL

The exercise intervention is a 10-week program involving 40 minutes of aerobic exercise targeting 60-75% of maximum heart rate on 3 days each week, with an additional 5-minute stretching warm up and cool down.

Exercise and Cognitive Remediation

Cognitive Remediation BEHAVIORAL

Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies. One-hour sessions will be conducted 3 times per week for 10 weeks.

Cognitive Remediation Only; Exercise and Cognitive Remediation

Eligibility Criteria

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

You may qualify if:

• a DSM-5 diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder based on the Structured Diagnostic Interview for DSM-5;
• no changes in prescribed psychotropic medication dosage or type for at least 1 month;
• medical clearance from a physician to participate in the exercise program;
• currently exhibiting a sedentary lifestyle, as defined by exercising less than 3 days/wk for at least 20 minutes each time;
• no current active suicidal ideation; and 6) fluent in English.

You may not qualify if:

• positive screen for a major neurocognitive disorder (as indicated by a score below 23 on the Folstein Mini Mental Exam or a positive score on the HELPS Brain Injury Screening using only cognitive items for "P" items);
• DSM-5 diagnosis of substance use disorder other than nicotine or caffeine in the last 6 months, or bulimia within the last 6 months;
• body mass index greater than 45; a BMI of 45 was selected as the upper limit in order to screen out individuals with Class III obesity who might be more prone to musculoskeletal injuries than individuals with a BMI at or less than 45; and
• for women, currently pregnant, plans to be pregnant in the next year, or currently breastfeeding.

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• McGurk SR, Otto MW, Fulford D, Cutler Z, Mulcahy LP, Talluri SS, Qiu WQ, Gan Q, Tran I, Turner L, DeTore NR, Zawacki SA, Khare C, Pillai A, Mueser KT. A randomized controlled trial of exercise on augmenting the effects of cognitive remediation in persons with severe mental illness. J Psychiatr Res. 2021 Jul;139:38-46. doi: 10.1016/j.jpsychires.2021.04.033. Epub 2021 May 13.

  PMID: 34022474 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Interventions

Exercise; Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susan McGurk, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Michael Otto, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 29, 2014
• Study Start: May 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 4, 2018

Record last verified: 2018-05

Locations

US (1)