← Back to Search

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

Must not have

Oxygen-dependent chronic obstructive pulmonary disease

Severe LE spasticity (Ashworth >2) due to inability to exercise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need oxygen therapy for my COPD.

Select...

I have severe leg stiffness because I can't exercise.

Select...

I have severe difficulty with coordination or ignoring one side of my body.

Select...

I have not been hospitalized for heart or lung disease in the last 3 months.

Select...

I don't have any major nerve, bone, or blood vessel issues that would stop me from exercising.

Select...

I have been diagnosed with a neurological disease like MS, Alzheimer's, or Parkinson's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oxygen uptake (VO2)

Secondary study objectives

Flow-mediated Dilation

Middle cerebral artery velocity

Middle cerebral artery velocity at rest

+1 more

Other study objectives

10-Meter Walk Test

6-Minute Walk Test (6MWT)

Cerebral Blood Flow

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met