The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is: • Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise? Participants will walk on a treadmill with a partial body-weight support system and the gait training device. Researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (SBP), and A1c levels in the blood.
Stroke is a leading cause of death and permanent disability. About 795,000 strokes occur in the US each year and more than seven million Americans are living with effects of stroke. Cardiovascular diseases are commonly presented and are primary causes of death in stroke survivors. Numerous studies have proven the benefits of walking or other forms of aerobic exercise for cardiovascular and pulmonary function in people after stroke. This proposed randomized controlled efficacy trial will primarily examine whether the investigators' gait training can improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise. The investigators have recently developed a novel gait training device and a training program. The experimental group in the proposed project will undergo an 8-week gait training program using a treadmill with body-weight support and the investigators' novel gait training device. The control group will receive an 8-week sitting leg cycling exercise program with similar exercise intensity, frequency, and duration. The proposed project will examine differences between the two groups using a set of comprehensive outcome assessments of cardiovascular, pulmonary, and sensorimotor functions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
72
The gait training in the experimental group will use a treadmill with a partial body-weight support system and our gait training device. A gait training session will include 2-minute warming up at the beginning and 2-minute cooling down at the end, at a treadmill speed of 0.6 mph. After the warming up, the treadmill speed will increase at every two minutes by an increment of 0.2 mph. Participant's heart rate will be monitored throughout the training session by using a Polar OH1 optical HR sensor placed in the participant's left forearm. Researchers will stop the increase and maintain the same treadmill speed after the HR reaching the target heart rate zone of 50% - 60% of age-predicted heart rate reserve.
The leg cycling exercise will use a stationary bicycle and the similar protocol as in the experimental group. The cycling exercise will include 2-minute warming up in the beginning and 2-minute cooling down at the end with a speed of 10 rpm and resistance of level 1 of 4. After warming up, the speed will increase at every two minutes by an increment of 5 rpm until reaching the target heart rate zone of 50% - 60% of age-predicted maximum heart rate. If the participant cannot tolerate any more increase in cycling speed before reaching the target heart rate, the resistance will be increased. The training duration will be individualized at the beginning and increase weekly by 5 minutes, depending on the tolerance of the participant, up to the maximum of 30 minutes. Both heart rate and blood pressure will be monitored before, during, and after each session to ensure safety. Each session including setting up will be about one hour.
University of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGchanges in resting heart rate (rHR)
Resting heart rate (measured in beats per minute) will be measured using a Polar heart rate monitoring system.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
systolic blood pressure (SBP)
Systolic blood pressure (measured in mmHg) will be measured using a mercury sphygmomanometer.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
glycated hemoglobin (HbA1c)
HbA1c levels will be measured by collecting a drop of blood from the middle finger of the unaffected hand and use the A1CNow+ System for analysis.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in diastolic blood pressure (DBP)
Diastolic blood pressure (measured in mmHg) will be measured using a mercury sphygmomanometer.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in forced vital capacity (FVC)
To obtain FVC measurements (measured in liters (L)) nose clip will be used, and subject's lips will be sealed around the mouthpiece to prevent air from leaking. The study team member will verbally encourage the subject to keep inhaling and exhaling at the maximum capacity. For FVC measurement, the subject will be instructed to maximally inhale, and immediately exhale forcibly and maximally. This test will be repeated at least three times. At least one minute will be allowed between each repetition to avoid fatigue.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
clinical measurement of Functional Ambulation Category (FAC)
The measurement of FAC will determine an individual's walking ability based on the amount of human assistance needed. It includes six categories, with Category 0 indicating nonfunctional ambulation and Category 5 - independent ambulation on varying surfaces.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in exercise heart rate (eHR)
Heart rate will be obtained using a Polar heart rate monitoring system.
Time frame: These will be measured pre- and post-exercise for the intervention group.
changes in low-density lipoprotein cholesterol (LDL-C)
A blood sample will be drawn from the antecubital vein in the unaffected arm to be analyzed for plasma cholesterol (LDL-C) levels.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in vital capacity (VC)
To obtain VC measurements (measured in liters (L)) nose clip will be used, and subject's lips will be sealed around the mouthpiece to prevent air from leaking. The study team member will verbally encourage the subject to keep inhaling and exhaling at the maximum capacity. The subject will sit and first be asked to breathe normally three times. The subject will then be instructed immediately to maximally inhale or exhale and repeat four times. This test will be repeated at least three times. At least one minute will be allowed between each repetition to avoid fatigue.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in Berg Balance Scale (BBS) score
The BBS is a test consisting of 14 items, designed to measure balance performance in sitting, standing, and weight transfer activities. The minimum score is 0 and the maximum score is 56. Higher scores indicate greater balance performance.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in muscle activity of the affected leg for participants in the intervention group
The muscle activity will be measured by the recorded muscle electromyogram (EMG) signals.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in heart rate variability (HRV)
Heart rate variability will be obtained using electrocardiography (ECG).
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in stroke volume (SV)
Stroke Volume (SV), an indication of cardiac functioning, will be measured by non-invasive impedance cardiography.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in cardiac output (CO)
Cardiac Output (CO), an indication of cardiac functioning, will be measured by non-invasive impedance cardiography.
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
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