Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - 80
Updated:3/21/2019
Start Date:January 4, 2019
End Date:February 28, 2022
Contact:Sarah Doren
Email:strokerecovery@uc.edu
Phone:(513) 558-7487

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The objective of this study is to determine the optimal training intensity and the minimum
training duration needed to maximize immediate improvements in walking capacity in chronic
stroke. A single-blind, phase II, 3-site randomized controlled trial has been planned. Fifty
persons >6 months post stroke will randomize to either moderate-intensity aerobic locomotor
training or high-intensity interval locomotor training; each for 45 minutes, 3x/week for up
to 36 total sessions over approximately 12 weeks. Clinical measures of walking function,
aerobic fitness, daily walking activity and quality of life will be assessed at baseline
(PRE) and after 4, 8 and 12 weeks of training (POST-4WK, POST-8WK, POST-12WK).


Inclusion Criteria:

1. Age 40-80 years at time of consenting

2. Single stroke for which participant sought treatment, 6 months to 5 years prior to
consent date

3. Walking speed <1.0 m/s on the 10-meter walk test

4. Able to walk 10m over ground with assistive devices as needed and no continuous
physical assistance from another person (guarding and intermittent assistance for loss
of balance allowed)

5. Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)

6. Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 METs)

7. Able to communicate with investigators, follow a 2-step command and correctly answer
consent comprehension questions

Exclusion Criteria:

1. Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG
abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical
testing from the past year available to rule out)

2. Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded
exercise test in the absence of recent (past year) more definitive clinical testing
(e.g. stress nuclear imaging) with negative result

3. Hospitalization for cardiac or pulmonary disease within past 3 months

4. Implanted pacemaker or defibrillator

5. Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)

6. Severe lower limb spasticity (Ashworth >2)

7. Recent history (<3 months) of illicit drug or alcohol abuse or significant mental
illness

8. Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the
absence of depression management by a health care provider

9. Currently participating in physical therapy or another interventional study

10. Recent botulinum toxin injection to the paretic lower limb (<3 months) or planning to
have lower limb botulinum toxin injection in the next 4 months

11. Foot drop or lower limb joint instability without adequate stabilizing device, as
assessed by a physical therapist

12. Clinically significant neurologic disorder other than stroke or unable to walk outside
the home prior to stroke

13. Other significant medical condition likely to limit improvement or jeopardize safety
as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)

14. Pregnancy

15. Previous exposure to fast treadmill walking (>3 cumulative hours) during clinical or
research therapy in the past year
We found this trial at
3
sites
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Sandra Billinger, PT, PhD
Phone: 913-588-2697
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Pierce Boyne, DPT, PhD
Phone: 513-558-7487
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Newark, Delaware 19716
Principal Investigator: Darcy Reisman, PT, PhD
Phone: 302-831-4616
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Newark, DE
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