Exercise and Cognitive Training

Schizophrenia Clinical Trial

Official title:

Exercise and Cognitive Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326389
• Other study ID #: 3636
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 2017

Study information

• Verified date: May 2018
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Exercise
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.
• 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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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