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Fitness After Stroke Trial (FAST)

Primary Purpose

Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise MICT
Exercise HIIT
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring exercise, cerebrovascular, cardiovascular, walking, aerobic fitness, brain

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both sexes between the age of 20-85 years at time of consent Chronic ischemic or hemorrhagic stroke 6 months to 5 years at consent. People with stroke and newly diagnosed cardiovascular complications had >50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed. Ability to walk over ground with assistive devices and no continuous physical assistance from another person to perform tests for gait speed and six-minute walk test Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test. No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test. Able to communicate with investigators, follow 2-step command & correctly answer consent comprehension questions Currently participating in less than 150 minutes of physical activity/week assessed by the Rapid Assessment of Physical Activity Stable blood pressure & statin medication doses for 30 days prior to enrollment due to effects on vascular health/hemodynamics Exclusion Criteria: Hospitalization for cardiac or pulmonary disease within past 3 months Implanted pacemaker or defibrillator limiting exercise performance Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11) Reported pain that limits or interferes with activities of daily living and physical activity/exercise Severe LE spasticity (Ashworth >2) due to inability to exercise Recent history (<3 months) of illicit drug or alcohol abuse or diagnosis of significant mental illness Major post-stroke depression (Patient Health Questionnaire, PHQ-9 ≥ 1084) Currently participating in physical therapy targeting lower extremity function or another interventional study that may influence study outcomes Other significant neurologic, orthopedic or peripheral vascular conditions that would limit exercise participation Oxygen-dependent chronic obstructive pulmonary disease Diagnosis of other neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease) Self report pregnancy

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Moderate intensity, continuous training (MICT)

High intensity, interval exercise (HIIT)

Arm Description

After a 5-minute warm-up at 30% peak watts, MICT will consist of continuous exercise for 25 minutes at 55% of peak watts (range: 45%-65%). The average heart rate for each individual session should not exceed 70% (60-70%) of HR maximum to align with current exercise recommendations for stroke. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention.

After the 5-minute warm-up at 30% peak watts, HIIT will consist of repeated 1-minute, high intensity bursts ("on" interval) alternated with 1-minute interval recovery ("off" interval) for 25 minutes. The "on" interval will begin at 70% of peak watts (range: 65%-95%) followed by the "off" interval at 10% of peak watts. The average HR for the "on" intervals will not exceed 85% age predicted maximum (75-85%). There will be 13 minutes of "on" and 12 minutes of "off" interval exercise. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention.

Outcomes

Primary Outcome Measures

Oxygen uptake (VO2)
Assessing change in oxygen uptake during a submaximal exercise test

Secondary Outcome Measures

Middle cerebral artery velocity
Assessing change in middle cerebral artery velocity response to an acute exercise bout
Middle cerebral artery velocity at rest
Assessing change in middle cerebral artery velocity during a rest condition
Flow-mediated Dilation
Endothelial vascular function
Pulse Wave Velocity
Arterial stiffness

Full Information

First Posted
June 19, 2023
Last Updated
October 4, 2023
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05936008
Brief Title
Fitness After Stroke Trial
Acronym
FAST
Official Title
Investigating Exercise Prescription Parameters on Aerobic Fitness and Vascular Health After Stroke: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
People living with stroke have very low aerobic fitness, which can negatively impact brain health. Identifying the best exercise which includes exercise stimulus type (interval, continuous) or intensity, how hard to exercise (moderate, high) that benefit aerobic fitness, vascular health, and the brain's main blood vessels after stroke are unknown. This study is designed to determine the preliminary efficacy of high-volume HIIT to moderate intensity exercise using a seated stepper exercise device that allows the arms and legs to move back and forth.
Detailed Description
People with stroke often experience physical decline and aerobic fitness that can be reversed through exercise. Evidence has shown that participating in exercise benefits aerobic fitness and vascular health while less is known about brain health. However, the optimal exercise dose such as intensity and exercise type (continuous, interval) are not yet known. The long-term goal of this project is to develop and test strategies to be implemented in larger clinical trials to improve health in people living with stroke. For this preliminary efficacy trial, the Investigator will enroll 50 participants with chronic stroke, age 20-85 years, into a 4-week exercise program. Participants will be allocated to one of the following groups using minimization, a type of randomization based on the lower extremity Fugl-Meyer score: 1) moderate intensity continuous training (MICT), that serves as the control, or 2) high-intensity interval training (HIIT). Exercise will be performed on a recumbent stepper. The Investigator will: Assess the preliminary efficacy of HIIT on aerobic fitness (Aim 1), cerebrovascular hemodynamics (Aim 2), and vascular function (Aim 3). Current exercise recommendations for stroke use general exercise prescription principles for older adults and are not grounded on data generated from large, well-designed, randomized controlled trials in stroke. If aerobic exercise could be proven to reduce the number of "years of life lived with disability," it would offer a key strategy for: 1) minimizing dependence on caregiver support, 2) reducing overall healthcare costs, and 3) extending quality of life for individuals after stroke. This proposed trial will address an important gap in knowledge for both the scientific and clinical communities and provide essential data that will contribute to future exercise prescription recommendations focused on stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke Hemorrhagic
Keywords
exercise, cerebrovascular, cardiovascular, walking, aerobic fitness, brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The Investigator will use an adaptive randomization design called minimization to ensure balance across groups. Intervention arms include: Moderate intensity, continuous training exercise High intensity, interval training exercise
Masking
ParticipantOutcomes Assessor
Masking Description
Outcome assessors will be blinded to the participant's intervention group. Participants will not be given detailed information about the exercise groups.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate intensity, continuous training (MICT)
Arm Type
Active Comparator
Arm Description
After a 5-minute warm-up at 30% peak watts, MICT will consist of continuous exercise for 25 minutes at 55% of peak watts (range: 45%-65%). The average heart rate for each individual session should not exceed 70% (60-70%) of HR maximum to align with current exercise recommendations for stroke. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention.
Arm Title
High intensity, interval exercise (HIIT)
Arm Type
Active Comparator
Arm Description
After the 5-minute warm-up at 30% peak watts, HIIT will consist of repeated 1-minute, high intensity bursts ("on" interval) alternated with 1-minute interval recovery ("off" interval) for 25 minutes. The "on" interval will begin at 70% of peak watts (range: 65%-95%) followed by the "off" interval at 10% of peak watts. The average HR for the "on" intervals will not exceed 85% age predicted maximum (75-85%). There will be 13 minutes of "on" and 12 minutes of "off" interval exercise. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Exercise MICT
Other Intervention Name(s)
aerobic exercise
Intervention Description
Standard of care, exercise recommendations for people with stroke
Intervention Type
Behavioral
Intervention Name(s)
Exercise HIIT
Other Intervention Name(s)
HIIT, aerobic exercise, anaerobic exercise
Intervention Description
The HIIT protocol consists of Short Interval, High Volume exercise at 1-minute exercise bouts followed by 1-minute active recovery for 25 minutes.
Primary Outcome Measure Information:
Title
Oxygen uptake (VO2)
Description
Assessing change in oxygen uptake during a submaximal exercise test
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Middle cerebral artery velocity
Description
Assessing change in middle cerebral artery velocity response to an acute exercise bout
Time Frame
Baseline, 4 weeks
Title
Middle cerebral artery velocity at rest
Description
Assessing change in middle cerebral artery velocity during a rest condition
Time Frame
Baseline, 4 weeks
Title
Flow-mediated Dilation
Description
Endothelial vascular function
Time Frame
Baseline, 4 weeks
Title
Pulse Wave Velocity
Description
Arterial stiffness
Time Frame
Baseline, 4 weeks
Other Pre-specified Outcome Measures:
Title
6-Minute Walk Test (6MWT)
Description
Walking endurance using the 6MWT
Time Frame
Baseline, 4 weeks
Title
10-Meter Walk Test
Description
Gait speed using the 10-Meter Walk Test
Time Frame
Baseline, 4 weeks
Title
Cerebral Blood Flow
Description
Global and regional blood flow using MRI
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both sexes between the age of 20-85 years at time of consent Chronic ischemic or hemorrhagic stroke 6 months to 5 years at consent. People with stroke and newly diagnosed cardiovascular complications had >50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed. Ability to walk over ground with assistive devices and no continuous physical assistance from another person to perform tests for gait speed and six-minute walk test Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test. No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test. Able to communicate with investigators, follow 2-step command & correctly answer consent comprehension questions Currently participating in less than 150 minutes of physical activity/week assessed by the Rapid Assessment of Physical Activity Stable blood pressure & statin medication doses for 30 days prior to enrollment due to effects on vascular health/hemodynamics Exclusion Criteria: Hospitalization for cardiac or pulmonary disease within past 3 months Implanted pacemaker or defibrillator limiting exercise performance Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11) Reported pain that limits or interferes with activities of daily living and physical activity/exercise Severe LE spasticity (Ashworth >2) due to inability to exercise Recent history (<3 months) of illicit drug or alcohol abuse or diagnosis of significant mental illness Major post-stroke depression (Patient Health Questionnaire, PHQ-9 ≥ 1084) Currently participating in physical therapy targeting lower extremity function or another interventional study that may influence study outcomes Other significant neurologic, orthopedic or peripheral vascular conditions that would limit exercise participation Oxygen-dependent chronic obstructive pulmonary disease Diagnosis of other neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease) Self report pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra A Billinger, PhD
Phone
913-945-6685
Email
sbillinger@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sasha Moores
Phone
913-588-2697
Email
smoores@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra A Billinger, PhD
Organizational Affiliation
KU Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Moores
Phone
913-588-2697
Email
smoores@kumc.edu
First Name & Middle Initial & Last Name & Degree
Bria Bartsch, OT
Email
bbartsch@kumc.edu

12. IPD Sharing Statement

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Fitness After Stroke Trial

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