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Completed

NCT Number: NCT03760016

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

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware, Newark, Delaware, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40-80 years at time of consenting
  • Single stroke for which participant sought treatment, 6 months to 5 years prior to consent date
  • 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)
  • 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
  • Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
  • Severe lower limb spasticity (Ashworth >2)
  • Recent history (<3 months) of illicit drug or alcohol abuse or significant 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
  • 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
  • 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
  • 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) during clinical or research therapy in the past year

Treatment and study plan

Moderate-Intensity Aerobic Training

Behavioral

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.

High-intensity interval training

Behavioral

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.

Primary outcomes

  1. Six-Minute Walk Test Distance

    Time frame: Change Six-Minute Walk Test Distance from Baseline to 4 Weeks

    Total distance walked in 6 minutes in meters

  2. Six-Minute Walk Test Distance

    Time frame: Change Six-Minute Walk Test Distance from Baseline to 8 Weeks

    Total distance walked in 6 minutes in meters

  3. Six-Minute Walk Test Distance

    Time frame: Change Six-Minute Walk Test Distance from Baseline to 12 Weeks

    Total distance walked in 6 minutes in meters

Secondary outcomes

  1. Comfortable Gait Speed

    Time frame: Change from Baseline to 4 Weeks

    From 10-meter walk test, in meters per second

  2. Comfortable Gait Speed

    Time frame: Change from Baseline to 8 Weeks

    From 10-meter walk test, in meters per second

  3. Comfortable Gait Speed

    Time frame: Change from Baseline to 12 Weeks

    From 10-meter walk test, in meters per second

  4. Fast Gait Speed

    Time frame: Change from Baseline to 4 Weeks

    From 10-meter walk test, in meters per second

  5. Fast Gait Speed

    Time frame: Change from Baseline to 8 Weeks

    From 10-meter walk test, in meters per second

  6. Fast Gait Speed

    Time frame: Change from Baseline to 12 Weeks

    From 10-meter walk test, in meters per second

  7. Aerobic Fitness

    Time frame: Change from Baseline to 4 Weeks

    Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute

  8. Aerobic Fitness

    Time frame: Change from Baseline to 8 Weeks

    Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute

  9. Aerobic Fitness

    Time frame: Change from Baseline to 12 Weeks

    Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute

  10. PROMIS-Fatigue Scale

    Time frame: Change from Baseline to 4 Weeks

    The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American.

  11. PROMIS-Fatigue Scale

    Time frame: Change from Baseline to 8 Weeks

    The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American.

  12. PROMIS-Fatigue Scale

    Time frame: Change from Baseline to 12 Weeks

    The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American.

Other outcomes

  1. Exercise Capacity

    Time frame: Change from Baseline to 4 Weeks

    Time to exhaustion during treadmill graded exercise test, recorded in minutes

  2. Exercise Capacity

    Time frame: Change from Baseline to 8 Weeks

    Time to exhaustion during treadmill graded exercise test, recorded in minutes

  3. Exercise Capacity

    Time frame: Change from Baseline to 12 Weeks

    Time to exhaustion during treadmill graded exercise test, recorded in minutes

  4. Peak Oxygen Consumption Rate

    Time frame: Change from Baseline to 4 Weeks

    Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute

  5. Peak Oxygen Consumption Rate

    Time frame: Change from Baseline to 8 Weeks

    Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute

  6. Peak Oxygen Consumption Rate

    Time frame: Change from Baseline to 12 Weeks

    Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute

  7. Metabolic Cost of Gait

    Time frame: Change from Baseline to 4 Weeks

    Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter

  8. Metabolic Cost of Gait

    Time frame: Change from Baseline to 8 Weeks

    Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter

  9. Metabolic Cost of Gait

    Time frame: Change from Baseline to 12 Weeks

    Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter

  10. EuroQol 5D-5L (EQ-5D-5L)

    Time frame: Change from Baseline to 4 Weeks

    A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25).

  11. EuroQol 5D-5L (EQ-5D-5L)

    Time frame: Change from Baseline to 8 Weeks

    A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25).

  12. EuroQol 5D-5L (EQ-5D-5L)

    Time frame: Change from Baseline to 12 Weeks

    A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25).

  13. Activities-specific Balance Confidence Scale

    Time frame: Change from Baseline to 4 Weeks

    A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item.

  14. Activities-specific Balance Confidence Scale

    Time frame: Change from Baseline to 8 Weeks

    A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item.

  15. Activities-specific Balance Confidence Scale

    Time frame: Change from Baseline to 12 Weeks

    A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item.

  16. Daily Walking Activity

    Time frame: Change from Baseline to 4 Weeks

    Mean daily step count recorded with activity monitor, recorded as steps per day

  17. Daily Walking Activity

    Time frame: Change from Baseline to 8 Weeks

    Mean daily step count recorded with activity monitor, recorded as steps per day

  18. Daily Walking Activity

    Time frame: Change from Baseline to 12 Weeks

    Mean daily step count recorded with activity monitor, recorded as steps per day

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Delaware
  • University of Kansas Medical Center

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2018
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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