To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Gait Training
  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
• Другое Leg Cycling Exercise
  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 inc

Первичные конечные точки

• changes in resting heart rate (rHR) [Срок оценки: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
• systolic blood pressure (SBP) [Срок оценки: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
• glycated hemoglobin (HbA1c) [Срок оценки: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]

Вторичные конечные точки (11)

• changes in diastolic blood pressure (DBP) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: These will be measured pre- and post-exercise for the intervention group.]
• changes in low-density lipoprotein cholesterol (LDL-C) [Срок оценки: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
• changes in vital capacity (VC) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
• changes in stroke volume (SV) [Срок оценки: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
• changes in cardiac output (CO) [Срок оценки: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]

Критерии участия

Критерии включения

• must be 18 to 80 years old
• male or female
• independent ambulation before stroke
• able to understand and follow verbal commands in English
• have physicians' approval for exercise
• be in a stable medical condition
• must be after the first stroke
• unable to walk independently
• in the chronic stage (at least 6 months after stroke onset)

Критерии исключения

• musculoskeletal or other disorders that prevent the participant from participating in the exercise
• blood pressure higher than 200/110 mm Hg
• diagnosis of severe depression
• functionally restricted passive movement in the major joints of lower limbs
• unable to speak or understand English
• unable to travel to the Research Laboratory
• currently participate in other walking training using treadmill with or without a body-weight support system
• body weight greater than 400 lbs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Kansas Medical Center — Kansas City

Идентификаторы

NCT: NCT06247553 · MOD00042952

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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