Cerebral StrokeNCT02272426
The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke
A study testing CARET and CTI in people with Cerebral Stroke, run by University of Miami at 2 sites in United States.
Trial summary
It is estimated that 2 out of 3 patients with a stroke have some problems with their memory, difficulties performing certain tasks, making decisions and learning new things. In addition, many stroke patients do not get regular exercise and are often sedentary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- CARET and CTI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to 20 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemic or hemorrhagic stroke
- Modified Rankin Score (mRS) of <4 at screening
- Recently discharged from the hospital or rehabilitation program
- Male or female ≥18 years of age
- Less than ideal physical activity ≥ 3 months prior to enrollment (less than ideal physical (as defined by the American Heart Association)
- Able to walk ≥10 meters with or without assistance
Who cannot join
- Unable to follow instructions for exercise and cognitive interventions
- Any uncontrolled medical condition expected to limit life expectancy or interfere with participation in the trial (i.e. unstable cancer, severe depression or anxiety by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria)
- Abnormal stress test, as determined by the treating physician (unless cardiology clearance provided)
- Active substance abuse or alcohol dependence
- Less than 6th grade reading level
- Uncorrected vision or hearing deficits that would preclude administration of the cognitive measures
- Unwilling or unable to provide written informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jackson Memorial Hospital
Miami, Florida, 33136
University of Miami Hospital
Miami, Florida, 33136
About this study
It is estimated that 2 out of 3 patients with a stroke have some problems with their memory, difficulties performing certain tasks, making decisions and learning new things. In addition, many stroke patients do not get regular exercise and are often sedentary. Both physical and cognitive exercise have the potential to improve quality of life, cognition, and overall health, but the safety and tolerability of such interventions is not clear in stroke patients. The investigators will examine these outcomes by allocating stroke survivor participants to one of two groups: a combined exercise and cognitive training program and a sham control group.
Read the detailed description
Stroke is well recognized as the leading cause of disability in the United States. Cognitive deficits after stroke are common, even in those without dementia prior to the event, and stroke patients with worse cognition on hospital admission have worse outcomes. Cognitive deficits contribute to stroke-related disability and mortality. Evidence suggests an interaction between cognitive deficits and physical limitations, and cognitive rehabilitation may improve functional outcomes post stroke. Recent data also suggest that both cognitive training and exercise interventions improve cognition in stroke patients, but few randomized trials of these interventions, alone or in combination, have been conducted.
We will study the effects of a Combined Aerobic and Resistance Exercise Training (CARET) program and CTI interventions on the primary outcome of safety, feasibility, and adherence among ischemic or hemorrhagic stroke survivors with mild to moderate disability. We hypothesize that these interventions are safe and tolerable, and that they will lead to improvements in our secondary outcomes of cognitive performance and quality of life. We will also explore the role of Brain Derived Neurotrophic Factor in cognitive changes related to the physical exercise intervention.
- Conditions
- Cerebral Stroke
- Being tested
- CARET, CTI, Sham CARET, Sham CTI
- Keywords
- Stroke, Exercise Training, Cognitive Training, Quality of Life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARETBehavioural
Combined Aerobic and Resistance Exercise Training
CTIBehavioural
Cognitive Training Intervention
Sham CARETBehavioural
Sham Combined Aerobic and Resistance Exercise Training
Sham CTIBehavioural
Sham Cognitive Training Intervention
| Study group | Role | What they receive |
|---|---|---|
| CARET + CTI | Experimental | Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI) Receives: Behavioral: CARET; Behavioral: CTI |
| Sham CARET + Sham CTI | Sham comparator | Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI) Receives: Behavioral: Sham CARET; Behavioral: Sham CTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent serious adverse events
To assess the number of participants with serious adverse events related to the interventions, comparing active groups versus the sham group.
Measured: At 12 weeks visit (post-intervention)
Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group
To assess participant adherence in the intervention group versus the sham group, comparing time on study.
Measured: At 12 weeks visit (post-intervention)
Secondary outcomes (4)
Change in Cognitive Performance on cognitive neuropsychological battery done at pre, post and 6 month follow-up visits
Global cognitive performance will be compared for the intervention groups versus the sham group, using a cognitive assessment battery.
Measured: Baseline to 6 months follow up
Change in Health Related Quality of Life - Depression
As measured by Center for Epidemiologic Studies Depression Scale (CES-D). Minimum score 0, maximum score 60, and a score of 16 or higher indicates clinical depression.
Measured: Baseline to 6 months follow up measure.
Change in Health Related Quality of Life - Daily Activities
As measured by Stroke impact scale scores measuring health related quality of life. Minimum score 16, maximum score 80. Higher scores indicate higher level of functionality in participants, while lower scores indicate a lower level of functionality.
Measured: Baseline to 6 months follow up
Change in blood plasma concentration of Brain Derived Neurotrophic Factor
Brain-derived neurotrophic factor (BDNF) levels will be compared between the exercise group and the sham group at baseline and 12 weeks.
Measured: Baseline to 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startNov 2014
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
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 Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Bugher Foundation
- Responsible party
- Principal investigator, Sebastian Koch, University of Miami
- Investigators
- Sebastian Koch, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272426
- Sponsor's protocol ID
- 20140203
- Status last verified
- Jun 2020
- First submitted
- 1 Oct 2014
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Koch S, Tiozzo E, Simonetto M, Loewenstein D, Wright CB, Dong C, Bustillo A, Perez-Pinzon M, Dave KR, Gutierrez CM, Lewis JE, Flothmann M, Mendoza-Puccini MC, Junco B, Rodriguez Z, Gomes-Osman J, Rundek T, Sacco RL. Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety. J Am Heart Assoc. 2020 May 18;9(10):e015377. doi: 10.1161/JAHA.119.015377. Epub 2020 May 12.
PubMed 32394777
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke
- ClinicalTrials.gov ID
- NCT02272426
- Acronym / sponsor ID
- 20140203
- Conditions
- Cerebral Stroke
- Keywords
- Stroke, Exercise Training, Cognitive Training, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Heart Association, Bugher Foundation
- Study start
- Nov 2014
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 23 Oct 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.
It is estimated that 2 out of 3 patients with a stroke have some problems with their memory, difficulties performing certain tasks, making decisions and learning new things. In addition, many stroke patients do not get regular exercise and are often sedentary. Both physical and cognitive exercise have the potential to improve quality of life, cognition, and overall health, but the safety and tolerability of such interventions is not clear in stroke patients. The investigators will examine these outcomes by allocating stroke survivor participants to one of two groups: a combined exercise and cognitive training program and a sham control group.
Detailed description
Stroke is well recognized as the leading cause of disability in the United States. Cognitive deficits after stroke are common, even in those without dementia prior to the event, and stroke patients with worse cognition on hospital admission have worse outcomes. Cognitive deficits contribute to stroke-related disability and mortality. Evidence suggests an interaction between cognitive deficits and physical limitations, and cognitive rehabilitation may improve functional outcomes post stroke. Recent data also suggest that both cognitive training and exercise interventions improve cognition in stroke patients, but few randomized trials of these interventions, alone or in combination, have been conducted.
We will study the effects of a Combined Aerobic and Resistance Exercise Training (CARET) program and CTI interventions on the primary outcome of safety, feasibility, and adherence among ischemic or hemorrhagic stroke survivors with mild to moderate disability. We hypothesize that these interventions are safe and tolerable, and that they will lead to improvements in our secondary outcomes of cognitive performance and quality of life. We will also explore the role of Brain Derived Neurotrophic Factor in cognitive changes related to the physical exercise intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARET + CTI | Experimental | Behavioral: CARET, Behavioral: CTICombined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI) |
| Sham CARET + Sham CTI | Sham comparator | Behavioral: Sham CARET, Behavioral: Sham CTIControl group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of ischemic or hemorrhagic stroke
- Modified Rankin Score (mRS) of <4 at screening
- Recently discharged from the hospital or rehabilitation program
- Male or female ≥18 years of age
- Less than ideal physical activity ≥ 3 months prior to enrollment (less than ideal physical (as defined by the American Heart Association)
Key exclusion criteria (7 listed)
- Unable to follow instructions for exercise and cognitive interventions
- Any uncontrolled medical condition expected to limit life expectancy or interfere with participation in the trial (i.e. unstable cancer, severe depression or anxiety by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria)
- Abnormal stress test, as determined by the treating physician (unless cardiology clearance provided)
- Active substance abuse or alcohol dependence
- Less than 6th grade reading level
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 |
|---|---|---|
| CARETCombined Aerobic and Resistance Exercise Training | Behavioural | CARET + CTI |
| CTICognitive Training Intervention | Behavioural | CARET + CTI |
| Sham CARETSham Combined Aerobic and Resistance Exercise Training | Behavioural | Sham CARET + Sham CTI |
| Sham CTISham Cognitive Training Intervention | Behavioural | Sham CARET + Sham CTI |
Primary outcome
Number of participants with treatment emergent serious adverse events
Time frame: At 12 weeks visit (post-intervention)
To assess the number of participants with serious adverse events related to the interventions, comparing active groups versus the sham group.
Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group
Time frame: At 12 weeks visit (post-intervention)
To assess participant adherence in the intervention group versus the sham group, comparing time on study.
4 secondary outcomes
Change in Cognitive Performance on cognitive neuropsychological battery done at pre, post and 6 month follow-up visits
Time frame: Baseline to 6 months follow up
Change in Health Related Quality of Life - Depression
Time frame: Baseline to 6 months follow up measure.
Change in Health Related Quality of Life - Daily Activities
Time frame: Baseline to 6 months follow up
Change in blood plasma concentration of Brain Derived Neurotrophic Factor
Time frame: Baseline to 6 month follow up
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 19 Jun 2020.
- Derived from this study: PubMed 32394777Koch S, Tiozzo E, Simonetto M, Loewenstein D, Wright CB, Dong C, Bustillo A, Perez-Pinzon M, Dave KR, Gutierrez CM, Lewis JE, Flothmann M, Mendoza-Puccini MC, Junco B, Rodriguez Z, Gomes-Osman J, Rundek T, Sacco RL. Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety. J Am Heart Assoc. 2020 May 18;9(10):e015377. doi: 10.1161/JAHA.119.015377. Epub 2020 May 12.
Related trials for Cerebral Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Sebastian Koch, M.D. principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARET and CTI in people with Cerebral Stroke, run by University of Miami at 2 sites 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 6 inclusion and 7 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 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Number of participants with treatment emergent serious adverse events (time frame: At 12 weeks visit (post-intervention)). The study lists 2 primary outcomes in all. 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 NCT02272426, 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 19 Jun 2020.