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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: High-Intensity Interval Training; Behavioral: Moderate-Intensity Aerobic Training

• Registration Number: NCT03760016
• Lead Sponsor: University of Cincinnati

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2019-01-04
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Results First Submitted: 2023-07-13
• Results First Submitted QC: 2023-07-18
• Results First Posted: 2023-07-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Intensity Interval Training	High-Intensity Interval Training	-
Moderate-Intensity Aerobic Training	Moderate-Intensity Aerobic Training	-

Primary Outcome Measures

Name	Time	Method
Six-Minute Walk Test Distance	Change Six-Minute Walk Test Distance from Baseline to 12 Weeks	Total distance walked in 6 minutes in meters

Secondary Outcome Measures

Name	Time	Method
Comfortable Gait Speed	Change from Baseline to 12 Weeks	From 10-meter walk test, in meters per second
Fast Gait Speed	Change from Baseline to 12 Weeks	From 10-meter walk test, in meters per second
Aerobic Fitness	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
PROMIS-Fatigue Scale	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.

Trial Locations

Locations (3)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

University of Delaware; 🇺🇸 Newark, Delaware, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States