The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke
1 other identifier
interventional
132
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 23, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2019
CompletedJune 19, 2020
June 1, 2020
4.4 years
October 1, 2014
June 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (4)
Change in Cognitive Performance on cognitive neuropsychological battery done at pre, post and 6 month follow-up visits
Baseline to 6 months follow up
Change in Health Related Quality of Life - Depression
Baseline to 6 months follow up measure.
Change in Health Related Quality of Life - Daily Activities
Baseline to 6 months follow up
Change in blood plasma concentration of Brain Derived Neurotrophic Factor
Baseline to 6 month follow up
Study Arms (2)
CARET + CTI
EXPERIMENTALCombined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)
Sham CARET + Sham CTI
SHAM COMPARATORControl group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- American Heart Associationcollaborator
- Bugher Foundationcollaborator
Study Sites (2)
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Related Publications (1)
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.
PMID: 32394777DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Koch, M.D.
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
October 1, 2014
First Posted
October 23, 2014
Study Start
November 1, 2014
Primary Completion
March 20, 2019
Study Completion
March 20, 2019
Last Updated
June 19, 2020
Record last verified: 2020-06