Neural and Vascular Modulation With Isometric Handgrip Training in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in resting blood pressure (BP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Sham Training
The intervention is an 8-week sham training protocol that consists of handgrip exercises performed by the participant at home, with a frequency of three sessions per week.
Participants will log their exercise times as well as recovery status and training loads (borg scale) throughout the 8 weeks of intervention.
干预措施: Sham Training (Device)
Isometric Handgrip Training
The intervention is an 8-week isometric handgrip training protocol that consists of handgrip exercises performed by the participant at home, with a frequency of three sessions per week. Participants will log their exercise times as well as their perceived rate of exertion and recovery status throughout the 8 weeks.
干预措施: Isometric handgrip exercise training (Device)
结局指标
主要结局
Change in resting blood pressure (BP)
时间窗: Baseline, 8-weeks post-intervention
Resting BP will be recorded
Change in standard deviation BP variability
时间窗: Baseline, 8-weeks post-intervention
Resting beat-to-beat BP will be continuously measured for 10 min. Then, the standard deviation, and BP variability in mmHg will be calculated
Change in average real BP variability
时间窗: Baseline, 8-weeks post-intervention
Resting beat-to-beat BP will be continuously measured for 10 min. Then, the average variability in mmHg will be calculated.
Change in the coefficient of variation of BP variability
时间窗: Baseline, 8-weeks post-intervention
Resting beat-to-beat BP will be continuously measured for 10 min. Then, the coefficient of variation of BP variability in % will be calculated.
Change in Brachial artery flow-mediated dilation (FMD)
时间窗: Baseline, 8-weeks post-intervention
FMD of the brachial artery will be measured using doppler ultrasound. The image of the brachial artery will be obtained in the distal third of the arm (2-10 cm above the antecubital fossa) using a multi-frequency linear probe attached to a high-resolution Doppler US.
Change in Vascular stiffness
时间窗: Baseline, 8-weeks post-intervention
Vascular stiffness will be quantified as pulse wave velocity using applanation tonometry with a high-fidelity micromanometer. It will be reported in meters per second (m/s).
次要结局
- Change in 24-hour ambulatory BP monitoring (ABPM)(Baseline, 8-weeks post-intervention)
- Change in resting muscle sympathetic nerve activity (MSNA)(Baseline, 8-weeks post-intervention)
- Change in BP reactivity to cold pressor test (CPT)(Baseline, 8-weeks post-intervention)
- Change in heart rate reactivity to cold pressor test (CPT)(Baseline, 8-weeks post-intervention)
- Change in MSNA reactivity to cold pressor test (CPT)(Baseline, 8-weeks post-intervention)
- Change in BP reactivity to handgrip exercise(Baseline, 8-weeks post-intervention)
- Change in heart rate reactivity to handgrip exercise(Baseline, 8-weeks post-intervention)
- Change in MSNA reactivity to handgrip exercise(Baseline, 8-weeks post-intervention)
- Change in skeletal muscle oxygenation during handgrip exercise(Baseline, 8-weeks post-intervention)
- Change in interstitial muscle pH during handgrip exercise(Baseline, 8-weeks post-intervention)
- Change in cardiac baroreflex sensitivity(Baseline, 8-weeks post-intervention)
- Change in sympathetic baroreflex sensitivity(Baseline, 8-weeks post-intervention)
- Change in Inflammatory markers: C-Reactive Protein (CRP)(Baseline, 8-weeks post-intervention)
- Change in Inflammatory markers: Interleukin-6 (IL-6)(Baseline, 8-weeks post-intervention)
- Change in Inflammatory markers: endothelin(Baseline, 8-weeks post-intervention)
- Change in Inflammatory markers: asymmetric dimethyl arginine (ADMA)(Baseline, 8-weeks post-intervention)
- Change in Inflammatory markers: phospholipase A2 (PLA-2)(Baseline, 8-weeks post-intervention)
研究者
Jeanie Park
Associate Professor
Emory University