Purpose

People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.

Condition

Eligibility

Eligible Ages
Between 30 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 30-85 years at time of consenting - Hemiparesis from ischemic and/or hemorrhagic strokes - Most recent stroke for which participant sought treatment, at least 6 months prior to study consent - Walking speed <1.0 m/s on the 10-meter walk test - 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) - Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph) - Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 metabolic equivalents) - Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

Exclusion Criteria

  • 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 these conditions) - 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 - Hospitalization for cardiac or pulmonary disease within past 3 months - Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit - Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11) - Severe lower limb spasticity (Ashworth >2) - Known recent history (<3 months) of unstable substance abuse or unstable mental illness - Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider - Currently participating in physical therapy or another interventional study targeting walking function - Recent (<2 weeks) or planned changes in lower limb orthotic or spasticity management - Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist - Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke - Unable to walk outside the home prior to stroke - 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) - Pregnancy - Previous exposure to fast treadmill walking (>3 cumulative hours) in the past year

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Moderate-Intensity Aerobic Training
  • Behavioral: Moderate-Intensity Aerobic Training
    Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.
Experimental
High-Intensity Interval Training
  • Behavioral: High-Intensity Interval Training
    Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Sasha Moores
913-588-2697
reachlab@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Cincinnati

Study Contact

Madison Yeazell
513-558-7487
strokerecovery@uc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.