HIT-Stroke Trial 2

Launched by UNIVERSITY OF CINCINNATI · Feb 12, 2024

Keywords

ClinConnect Summary

The HIT-Stroke Trial 2 is a research study looking at how different levels of walking exercises can help people who have had a stroke and still have trouble walking. Participants in the study will be those aged between 30 and 85 who had a stroke at least six months ago and have a walking speed of less than 1 meter per second. If eligible, they will be assigned to either a moderate or vigorous walking exercise program, which will be guided by a physical therapist for 45 minutes, three times a week for 12 weeks.

Throughout the trial, participants will have their walking abilities checked at the beginning, after 4, 8, and 12 weeks of training, and again three months after the program ends. This is to see how well each type of exercise works in improving walking function. It’s important to note that participants need to be able to walk at least 10 meters, even with the help of walking aids, and be in stable health overall to qualify. This study will not only help participants but also contribute to better understanding how exercise can assist stroke recovery.

Gender

ALL

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