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Behavioral Intervention
Exercise for Stroke Recovery (FAST Trial)
Phase 2
Recruiting
Led By Sandra A Billinger, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to communicate with investigators, follow 2-step command & correctly answer consent comprehension questions
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks
Awards & highlights
FAST Trial Summary
This trial will study the best exercise to help stroke survivors improve their aerobic fitness and brain health.
Who is the study for?
This trial is for adults aged 20-85 who've had a stroke (ischemic or hemorrhagic) between 6 months and 5 years ago. Participants should be able to exercise minimally, walk with assistive devices without constant help, and not be very active currently. Excluded are those with severe spasticity, recent substance abuse, certain medical conditions like severe COPD or neurological diseases, pregnant women, recent hospitalizations for heart/lung issues, pacemakers that limit exercise, significant pain affecting daily life or depression.Check my eligibility
What is being tested?
The study tests the effectiveness of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on aerobic fitness in stroke survivors using a seated stepper device. It aims to find out which type and intensity of exercise best improve fitness levels and vascular health after a stroke.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial's exercises, participants may experience general workout-related side effects such as muscle soreness or fatigue. Those with pre-existing conditions might have an increased risk of cardiovascular events during intense physical activity.
FAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and follow instructions and answer questions about the study.
Select...
I can walk with tools like a cane but don’t need someone to help me all the time.
Select...
I am between 20 and 85 years old.
FAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxygen uptake (VO2)
Secondary outcome measures
Flow-mediated Dilation
Middle cerebral artery velocity
Middle cerebral artery velocity at rest
+1 moreOther outcome measures
10-Meter Walk Test
6-Minute Walk Test (6MWT)
Cerebral Blood Flow
FAST Trial Design
2Treatment groups
Active Control
Group I: High intensity, interval exercise (HIIT)Active Control1 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.
Group II: Moderate intensity, continuous training (MICT)Active Control1 Intervention
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.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,220 Total Patients Enrolled
8 Trials studying Stroke
633 Patients Enrolled for Stroke
Sandra A Billinger, PhDPrincipal InvestigatorKU Medical Center
1 Previous Clinical Trials
91 Total Patients Enrolled
1 Trials studying Stroke
91 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and follow instructions and answer questions about the study.You have a pacemaker or defibrillator that restricts your ability to exercise.I need oxygen therapy for my COPD.I have severe leg stiffness because I can't exercise.My pain stops me from doing daily tasks or exercising.I can walk with tools like a cane but don’t need someone to help me all the time.I have severe difficulty with coordination or ignoring one side of my body.You have used illegal drugs or drank a lot of alcohol in the past three months, or have a serious mental illness.I am currently in physical therapy for my legs or in another study.I can safely do moderate exercise without health risks.You have severe depression after a stroke, as indicated by a specific questionnaire.My blood pressure and statin doses have been stable for the last 30 days.I have not been hospitalized for heart or lung disease in the last 3 months.You are not currently doing at least 150 minutes of physical activity per week, as measured by a specific test.I don't have any major nerve, bone, or blood vessel issues that would stop me from exercising.I am between 20 and 85 years old.I have been diagnosed with a neurological disease like MS, Alzheimer's, or Parkinson's.I had a stroke between 6 months and 5 years ago.You need to be able to exercise continuously at a certain level of difficulty on a special machine for a short time to show that you can handle the physical test.
Research Study Groups:
This trial has the following groups:- Group 1: High intensity, interval exercise (HIIT)
- Group 2: Moderate intensity, continuous training (MICT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project accept participants that are aged 18 and above?
"This research project is seeking patients over the age of majority and below 85 years old."
Answered by AI
How many volunteers are currently enrolled in this medical experiment?
"Affirmative. The information available on clinicaltrials.gov suggests that this medical trial, which was initially posted on July 1st 2023, is actively recruiting participants. 50 people need to be recruited for the research from a single site."
Answered by AI
Has the FDA sanctioned Moderate intensity, continuous training (MICT) as a legitimate form of treatment?
"Due to the lack of efficacy data, our group at Power evaluated Moderate intensity, continuous training (MICT) with a score of 2 on safety."
Answered by AI
Can individuals still apply to this research endeavor?
"Yes, there is evidence on clinicaltrials.gov that this experiment is currently in need of participants; it was initially posted on July 1st 2023 and its most recent update was July 17th 2023. The trial seeks to recruit 50 individuals from one centre."
Answered by AI
What are the eligibilty criteria for participating in this trial?
"To be eligible to partake in this study, patients must have suffered a stroke and fall within the age range of 20-85. As such, 50 individuals will be accepted into this medical trial."
Answered by AI
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