Handgrip Exercise Training and CKD

Официальное название

Neural and Vascular Modulation With Isometric Handgrip Training in Chronic Kidney Disease

Обзор

The purpose of this study is to find out if regular handgrip exercise performed at home can improve blood pressure at rest and during exercise in patients with chronic kidney disease (CKD). This study is also intended to understand what causes an increase in blood pressure at rest and during exercise (i.e., increased adrenaline levels, or decreased ability of blood vessels to dilate). Patients with CKD will be recruited from primary care, Nephrology and other subspecialty Clinics throughout the Emory Healthcare System. Participants will attend 4 visits of 2-3 hours and 3 visits of 1-2 hours. The home exercise training will last for 8 weeks.

Подробное описание

The goal of this study is to learn more about if exercising the grip strength at home can improve blood pressure control. Patients with Chronic Kidney Disease (CKD) have a much higher risk of cardiovascular problems than healthy people. Early results show that patients with CKD have issues controlling their blood pressure. The investigators think that this type of exercise, where you use a grip device to squeeze, might help improve health by lowering blood pressure. Even though the American Heart Association recommends this kind of exercise, not many people are using it. The study population will consist of 50 patients with CKD in stages III and IV. They will do the grip exercise three times a week at home, squeezing a grip device four times for 2 minutes with each hand. The research team will also check their flight-or-flight control and artery health to see how this exercise training might help. The investigators will collect some blood samples to understand what changes are happening in their bodies. Patients with CKD will attend 4 visits of 2-3 hours and 3 visits of 1-2 hours. The home exercise training will last for 8 weeks. Therefore, the approximate study duration is around 12 weeks. Patients with CKD will be recruited from primary care, Nephrology and other subspecialty Clinics throughout the Emory Healthcare System. No bank for specimens or data will be maintained. The informed consent process will occur in-person. This study will help to find new ways to improve CKD cardiovascular health.

Вмешательства

• Устройство Isometric handgrip exercise training
  Maximum voluntary contraction (MVC) will be assessed first in both hands using a hand dynamometer with a digital display (Handexer HFEH20); the participant squeezes the hand dynamometer as hard as they can for 3 to 5 attempts to obtain the MVC. The intervention is an 8- week training protocol that consists of handgrip exercises performed by the participant at home. Each cycle of sustained handgrip exercise consists of sustained squeezing of the hand dynamometer at 30% of MVC for 2 minutes (i.e.
• Устройство Sham Training
  Each cycle of sustained handgrip exercise consists of sustained squeezing of the hand dynamometer at 3 - 5% of MVC rather than 30%.

Первичные конечные точки

• Change in resting blood pressure (BP) [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in standard deviation BP variability [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in average real BP variability [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in the coefficient of variation of BP variability [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in Brachial artery flow-mediated dilation (FMD) [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in Vascular stiffness [Срок оценки: Baseline, 8-weeks post-intervention]

Вторичные конечные точки (12)

• Change in 24-hour ambulatory BP monitoring (ABPM) [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in resting muscle sympathetic nerve activity (MSNA) [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in BP reactivity to cold pressor test (CPT) [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in heart rate reactivity to cold pressor test (CPT) [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in MSNA reactivity to cold pressor test (CPT) [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in BP reactivity to handgrip exercise [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in heart rate reactivity to handgrip exercise [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in MSNA reactivity to handgrip exercise [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in skeletal muscle oxygenation during handgrip exercise [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in interstitial muscle pH during handgrip exercise [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in cardiac baroreflex sensitivity [Срок оценки: Baseline, 8-weeks post-intervention]
• Change in sympathetic baroreflex sensitivity [Срок оценки: Baseline, 8-weeks post-intervention]

Критерии участия

Критерии включения

• Patients with CKD (Stages IIIa and IV),
• Ages 45-85 years who do not regularly exercise (defined as exercising less than 20 minutes twice per week), willing and able to cooperate with the protocol.
• CKD Stages III and IV will be defined as reduction in estimated glomerular filtration rate (eGFR) to 15-59 cc/minute as calculated by the modified CKD-EPI equations.
• Patients with CKD must have stable renal function (no greater than a 20% reduction in eGFR over the prior 3 months).

Критерии исключения

• Severe CKD (eGFR<15 cc/minute)
• Metabolic alkalosis (serum bicarbonate > 28 meq/L)
• Ongoing drug or alcohol abuse
• Diabetic neuropathy
• Any serious systemic disease that might influence survival
• Severe anemia with hgb level <10 g/dL
• Clinical evidence of congestive heart failure or ejection fraction below 35%, symptomatic heart disease determined by prior electrocardiogram, stress test, and/or history, treatment with central alpha agonists (clonidine)
• Uncontrolled hypertension with BP greater than 170/100 mm Hg
• Low blood pressure with BP less than 100/50
• Pregnancy or plans to become pregnant
• Current treatment with MAO inhibitors
• Inability to perform handgrip exercise

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

Другое

Центры проведения

США · 1 центр

• Emory University — Atlanta

Идентификаторы

NCT: NCT07094906 · STUDY00009157

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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