Clinical trial NCT06268041: HIT-Stroke Trial 2
Official title: Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: gait
aerobic
locomotion
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Kansas Medical Center
name: University of Delaware
First posted: 2024-02-20
Enrollment: 156
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 6-Minute Walk Test Distance
timeFrame: Change from Baseline to 12 weeks
Secondary outcomes:
measure: 6-Minute Walk Test Distance
timeFrame: Change from Baseline to 3 month follow up
measure: Self-Selected Gait Speed
timeFrame: Change from Baseline to 12 weeks
measure: Fastest Gait Speed
timeFrame: Change from Baseline to 12 weeks
measure: PROMIS-Fatigue Scale version 8a
timeFrame: Change from Baseline to 3 month follow up
measure: Aerobic Capacity
timeFrame: Change from Baseline to 12 weeks
measure: EuroQol-5D-5L
timeFrame: Change from Baseline to 3 month follow up
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Pierce Boyne, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: