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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03760016
Other study ID # 2017-5325
Secondary ID R01HD093694
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2019
Est. completion date April 25, 2022

Study information

Verified date July 2023
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date April 25, 2022
Est. primary completion date April 25, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 metabolic equivalents) 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Cincinnati Cincinnati Ohio
United States University of Kansas Medical Center Kansas City Kansas
United States University of Delaware Newark Delaware

Sponsors (5)

Lead Sponsor Collaborator
University of Cincinnati 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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Boyne P, Billinger SA, Reisman DS, Awosika OO, Buckley S, Burson J, Carl D, DeLange M, Doren S, Earnest M, Gerson M, Henry M, Horning A, Khoury JC, Kissela BM, Laughlin A, McCartney K, McQuaid T, Miller A, Moores A, Palmer JA, Sucharew H, Thompson ED, Wag — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Exercise Capacity Time to exhaustion during treadmill graded exercise test, recorded in minutes 4 ,8, 12 weeks
Other Peak Oxygen Consumption Rate Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute 4 ,8, 12 weeks
Other Metabolic Cost of Gait Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter 4 ,8, 12 weeks
Other EuroQol 5D-5L (EQ-5D-5L) A 6-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and overall health. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total score will be calculated by averaging the scores for each item. 4 ,8, 12 weeks
Other Activities-specific Balance Confidence Scale 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 will be calculated by averaging the scores for each item. 4 ,8, 12 weeks
Other Daily Walking Activity Mean daily step count recorded with activity monitor, recorded as steps per day 4 ,8, 12 weeks
Primary Six-Minute Walk Test Distance Total distance walked in 6 minutes in meters Change Six-Minute Walk Test Distance from Baseline to 4 Weeks
Primary Six-Minute Walk Test Distance Total distance walked in 6 minutes in meters Change Six-Minute Walk Test Distance from Baseline to 8 Weeks
Primary Six-Minute Walk Test Distance Total distance walked in 6 minutes in meters Change Six-Minute Walk Test Distance from Baseline to 12 Weeks
Secondary Comfortable Gait Speed From 10-meter walk test, in meters per second 4 ,8, 12 weeks
Secondary Fast Gait Speed From 10-meter walk test, in meters per second 4 ,8, 12 weeks
Secondary Aerobic Fitness Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute 4 ,8, 12 weeks
Secondary PROMIS-Fatigue Scale 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 score will be calculated by averaging the scores for each item. 4 ,8, 12 weeks
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