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Exercise and Cognitive Training

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Cognitive Remediation
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive functioning

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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);
  2. DSM-5 diagnosis of substance use disorder other than nicotine or caffeine in the last 6 months, or bulimia within the last 6 months;
  3. 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
  4. for women, currently pregnant, plans to be pregnant in the next year, or currently breastfeeding.

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and Cognitive Remediation

Cognitive Remediation Only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2014
Last Updated
May 31, 2018
Sponsor
Boston University Charles River Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02326389
Brief Title
Exercise and Cognitive Training
Official Title
Exercise and Cognitive Training
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Impaired cognitive functioning is a common feature of schizophrenia and other serious mental illnesses that is related to poorer psychosocial functioning and less benefit from psychiatric rehabilitation. Research shows that cognitive remediation for persons with serious mental illness improves cognitive functioning and response to psychiatric rehabilitation. There is also evidence that physical activity such as aerobic exercise confers a benefit to cognitive functioning in both clinical and general population samples. The cognitive benefit of exercise is hypothesized to be the result of enhanced brain-derived neurotrophic factor (BDNF; a protein that promotes plasticity, reduces degeneration, and stimulates nerve cell survival). However, the potential synergistic effects of cognitive remediation and exercise on cognitive functioning have not been investigated in persons with serious mental illness. This pilot randomized controlled trial will evaluate the impact of adding a peer run exercise program to a standardized cognitive remediation program on cognitive functioning in 30 people with schizophrenia, schizoaffective disorder or bipolar disorder. All study participants will receive a 10-week cognitive remediation program shown in previous research to improve cognitive functioning. One-half (N = 15) of the participants will also receive a peer-led exercise program designed to promote cardiovascular fitness. The primary research questions addressed are: 1) Does the addition of the exercise program to cognitive remediation lead to greater improvements in cognitive functioning than cognitive remediation alone?, and, 2) Are improvements in cognitive functioning mediated (explained) by exercise-induced increases in BDNF? The results of this pilot study will inform the design of a larger, more definitive trial to evaluate the potential benefits of combining cognitive remediation and exercise in improving cognitive functioning and response to psychiatric rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Keywords
Cognitive functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Cognitive Remediation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Remediation Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite Measure of Change in Neurocognitive functioning
Description
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.
Time Frame
post- 10 week intervention and 2 weeks after end of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan McGurk, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Otto, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34022474
Citation
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.
Results Reference
derived

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Exercise and Cognitive Training

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