The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke

Cerebral Stroke Clinical Trial

Official title:

The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272426
• Other study ID #: 20140203
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 20, 2019

Study information

• Verified date: June 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Behavioral:
• CARET
Combined Aerobic and Resistance Exercise Training
• CTI
Cognitive Training Intervention
• Sham CARET
Sham Combined Aerobic and Resistance Exercise Training
• Sham CTI
Sham Cognitive Training Intervention

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida
United States	University of Miami Hospital	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	American Heart Association, Bugher Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 12 weeks visit (post-intervention)
Primary	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.	At 12 weeks visit (post-intervention)
Secondary	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.	Baseline to 6 months follow up
Secondary	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.	Baseline to 6 months follow up measure.
Secondary	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.	Baseline to 6 months follow up
Secondary	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.	Baseline to 6 month follow up