HIT-Stroke Trial 2

Stroke Clinical Trial

— HST2  

Official title:

Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268041
• Other study ID #: 427659
• Secondary ID: R01HD093694
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: April 2028

Study information

• Verified date: February 2024
• Source: University of Cincinnati
• Contact: Madison Yeazell
• Phone: 513-558-7487
• Email: strokerecovery[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: April 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

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 Kansas Medical Center	Kansas City	Kansas
United States	University of Delaware	Newark	Delaware

Sponsors (4)

Lead Sponsor	Collaborator
University of 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Minute Walk Test Distance	Total distance walked in 6 minutes in meters	Change from Baseline to 12 weeks
Secondary	6-Minute Walk Test Distance	Total distance walked in 6 minutes in meters	Change from Baseline to 3 month follow up
Secondary	Self-Selected Gait Speed	From 10-meter walk test at self-selected speed, in meters per second	Change from Baseline to 12 weeks
Secondary	Fastest Gait Speed	From 10-meter walk test at fastest speed, in meters per second	Change from Baseline to 12 weeks
Secondary	PROMIS-Fatigue Scale version 8a	An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5. Items are combined to obtain a total T score, where higher scores indicate greater fatigue.	Change from Baseline to 3 month follow up
Secondary	Aerobic Capacity	Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute	Change from Baseline to 12 weeks
Secondary	EuroQol-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 'misery score' will be calculated by averaging the scores for each item.	Change from Baseline to 3 month follow up