SchizophreniaNCT02326389
Exercise and Cognitive Training
A study testing Exercise and Cognitive Remediation in people with Schizophrenia and Schizoaffective Disorder, run by Boston University Charles River Campus at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Exercise and Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Being tested
- Exercise, Cognitive Remediation
- Keywords
- Cognitive functioning
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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 RemediationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: post- 10 week intervention and 2 weeks after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Mcgurk, Boston University
- Investigators
- Susan McGurk, PhD, Principal investigator, Boston UniversityMichael Otto, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326389
- Sponsor's protocol ID
- 3636
- Status last verified
- May 2018
- First submitted
- 18 Dec 2014
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34022474
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Cognitive Training
- ClinicalTrials.gov ID
- NCT02326389
- Acronym / sponsor ID
- 3636
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Keywords
- Cognitive functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and Cognitive Remediation | Experimental | Behavioral: Exercise, Behavioral: Cognitive RemediationThe 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. |
| Cognitive Remediation Only | Active comparator | Behavioral: Cognitive RemediationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Behavioural | Exercise and Cognitive Remediation |
| Cognitive RemediationParticipants 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. | Behavioural | Cognitive Remediation Only, Exercise and Cognitive Remediation |
Primary outcome
Composite Measure of Change in Neurocognitive functioning
Time frame: post- 10 week intervention and 2 weeks after end of intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Derived from this study: PubMed 34022474McGurk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan McGurk, PhD principal investigator
Boston University
Michael Otto, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cognitive Remediation in people with Schizophrenia and Schizoaffective Disorder, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Measure of Change in Neurocognitive functioning (time frame: post- 10 week intervention and 2 weeks after end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.