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

June 18, 2020 updated by: Sebastian Koch, University of Miami
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CARET + CTI
Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)
Behavioral: CARET
Combined Aerobic and Resistance Exercise Training
Behavioral: CTI
Cognitive Training Intervention
Sham Comparator: Sham CARET + Sham CTI
Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI)
Behavioral: Sham CARET
Sham Combined Aerobic and Resistance Exercise Training
Behavioral: Sham CTI
Sham Cognitive Training Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 weeks visit (post-intervention)
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.
At 12 weeks visit (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Change in Health Related Quality of Life - Depression
Time Frame: Baseline to 6 months follow up measure.
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.
Change in Health Related Quality of Life - Daily Activities
Time Frame: Baseline to 6 months follow up
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
Change in blood plasma concentration of Brain Derived Neurotrophic Factor
Time Frame: Baseline to 6 month follow up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

American Heart Association
Bugher Foundation

Investigators

  • Principal Investigator: Sebastian Koch, M.D., University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

March 20, 2019

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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