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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 45 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Device: 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. isometric) followed by 1 minute of rest.
    Other names:
    • IHT
Sham Comparator
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.
  • Device: Sham Training
    Each cycle of sustained handgrip exercise consists of sustained squeezing of the hand dynamometer at 3 - 5% of MVC rather than 30%.

Recruiting Locations

Emory University
Atlanta 4180439, Georgia 4197000 30322
Contact:
Jeanie Park, MD
404-727-1386
jeanie.park@emory.edu

More Details

Status
Recruiting
Sponsor
Emory University

Study Contact

Jeanie Park, MD
404-727-1386
jeanie.park@emory.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.