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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isometric Handgrip Training | Experimental | 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. |
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| Sham Training | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isometric handgrip exercise training | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in resting blood pressure (BP) | Resting BP will be recorded | Baseline, 8-weeks post-intervention |
| Change in standard deviation BP variability | Resting beat-to-beat BP will be continuously measured for 10 min. Then, the standard deviation, and BP variability in mmHg will be calculated | Baseline, 8-weeks post-intervention |
| Change in average real BP variability | Resting beat-to-beat BP will be continuously measured for 10 min. Then, the average variability in mmHg will be calculated. | Baseline, 8-weeks post-intervention |
| Change in the coefficient of variation of BP variability | Resting beat-to-beat BP will be continuously measured for 10 min. Then, the coefficient of variation of BP variability in % will be calculated. | Baseline, 8-weeks post-intervention |
| Change in Brachial artery flow-mediated dilation (FMD) | 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. | Baseline, 8-weeks post-intervention |
| Change in Vascular stiffness | 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). | Baseline, 8-weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour ambulatory BP monitoring (ABPM) | ABPM will be performed with SpaceLab "On Trak" ambulatory BP monitors. Upper arm readings will be taken for at least 24 hours. BP measurements will be made every 20 minutes from 7 AM to 11 PM (daytime period) and every 30 minutes from 11 PM to 7 AM (nighttime period). Average BP in mmHg will be recorded. | Baseline, 8-weeks post-intervention |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeanie Park, MD | Contact | 404-727-1386 | jeanie.park@emory.edu | |
| Fatima Kamal | Contact | 404-727-3717 | fatima.kamal@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeanie Park, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
Individual participant data that underline the results reported in this article after deidentification (text, tables, figures, and appendices) will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Beginning 9 months and ending 36 months following article publication.
Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be given upon request.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Sham Training | Device | Each cycle of sustained handgrip exercise consists of sustained squeezing of the hand dynamometer at 3 - 5% of MVC rather than 30%. |
|
| Change in resting muscle sympathetic nerve activity (MSNA) | The tungsten microelectrode will be inserted under ultrasound guidance into the peroneal nerve to measure MSNA. Nerve signals are preamplified (gain 1000), amplified (gain 50-100), filtered (700-2000 Hz), rectified, and integrated (time constant 0.1 sec) to obtain a mean voltage display of sympathetic nerve activity that is recorded. Muscle sympathetic bursts are identified by visual inspection and expressed as burst frequency (bursts min). | Baseline, 8-weeks post-intervention |
| Change in BP reactivity to cold pressor test (CPT) | The CPT will be performed by submerging the participant's hand in cold water (~0-4°C) up to the wrist for 1 minute. BP reactivity to the CPT in mmHg will be recorded. | Baseline, 8-weeks post-intervention |
| Change in heart rate reactivity to cold pressor test (CPT) | Heart rate reactivity to the CPT in beats per minute will be recorded. | Baseline, 8-weeks post-intervention |
| Change in MSNA reactivity to cold pressor test (CPT) | The MSNA reactivity in bursts/min will be recorded during the CPT using the tungsten microelectrode. | Baseline, 8-weeks post-intervention |
| Change in BP reactivity to handgrip exercise | BP reactivity (in mmHg) to handgrip exercise, an isometric hand contraction at 30% of their maximal voluntary contraction (MVC) for 3 minutes followed by inflation of the BP cuff in their upper arm for another 3 minutes, will be recorded. | Baseline, 8-weeks post-intervention |
| Change in heart rate reactivity to handgrip exercise | Heart rate reactivity in beats per minute will be recorded during the handgrip exercise. | Baseline, 8-weeks post-intervention |
| Change in MSNA reactivity to handgrip exercise | The MSNA reactivity in bursts/min will be recorded during the handgrip exercise. | Baseline, 8-weeks post-intervention |
| Change in skeletal muscle oxygenation during handgrip exercise | Skeletal muscle oxygenation will be calculated during handgrip exercise using Near-infrared spectroscopy (NIRS). NIRS will measure changes in oxyhemoglobin (oxygenated hemoglobin), deoxyhemoglobin (deoxygenated hemoglobin), and total hemoglobin. Percentage of oxyhemoglobin will be reported. | Baseline, 8-weeks post-intervention |
| Change in interstitial muscle pH during handgrip exercise | Change in interstitial muscle pH during handgrip exercise will be assessed using NIRS. | Baseline, 8-weeks post-intervention |
| Change in cardiac baroreflex sensitivity | The spontaneous cardiac baroreflex sensitivity expressed in milliseconds per mmHg (ms/mmHg) will be calculated at baseline, and at the end of the 8-week trial period. | Baseline, 8-weeks post-intervention |
| Change in sympathetic baroreflex sensitivity | The spontaneous sympathetic baroreflex sensitivity expressed in bursts per 100 heartbeats per mmHg will be calculated at baseline, and at the end of the 8-week trial period. | Baseline, 8-weeks post-intervention |
| Change in Inflammatory markers: C-Reactive Protein (CRP) | Blood will be collected at baseline, and at the end of the 8-week trial period to measure CRP. | Baseline, 8-weeks post-intervention |
| Change in Inflammatory markers: Interleukin-6 (IL-6) | Blood will be collected at baseline, and at the end of the 8-week trial period to measure IL-6. | Baseline, 8-weeks post-intervention |
| Change in Inflammatory markers: endothelin | Blood will be collected at baseline, and at the end of the 8-week trial period to measure endothelin. | Baseline, 8-weeks post-intervention |
| Change in Inflammatory markers: asymmetric dimethyl arginine (ADMA) | Blood will be collected at baseline, and at the end of the 8-week trial period to measure ADMA. | Baseline, 8-weeks post-intervention |
| Change in Inflammatory markers: phospholipase A2 (PLA-2) | Blood will be collected at baseline, and at the end of the 8-week trial period to measure PLA-2. | Baseline, 8-weeks post-intervention |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |