Chronic Kidney DiseasesNCT07094906
Handgrip Exercise Training and CKD
A study testing Isometric handgrip exercise training in people with Chronic Kidney Diseases, run by Emory University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Isometric handgrip exercise training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Emory University
Atlanta, Georgia, 30322
Jeanie Park, MD, 404-727-1386, jeanie.park@emory.edu
Fatima Kamal, 404-727-3717
About this study
Official title: Neural and Vascular Modulation With Isometric Handgrip Training in Chronic Kidney Disease
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Isometric handgrip exercise training, Sham Training
- Keywords
- Handgrip, Isometric handgrip exercise training (IHT), Blood pressure variability
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric handgrip exercise trainingDevice
Also called IHT
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.
Sham TrainingDevice
Each cycle of sustained handgrip exercise consists of sustained squeezing of the hand dynamometer at 3 - 5% of MVC rather than 30%.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Isometric handgrip exercise training |
| 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. Receives: Device: Sham Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting blood pressure (BP)
Resting BP will be recorded
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 8-weeks post-intervention
Secondary outcomes (17)
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.
Measured: Baseline, 8-weeks post-intervention
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8-weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Jeanie Park, Emory University
- Investigators
- Jeanie Park, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094906
- Sponsor's protocol ID
- STUDY00009157
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Vascular Modulation With Isometric Handgrip Training in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07094906
- Acronym / sponsor ID
- STUDY00009157
- Conditions
- Chronic Kidney Diseases
- Keywords
- Handgrip, Isometric handgrip exercise training (IHT), Blood pressure variability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric Handgrip Training | Experimental | Device: Isometric handgrip exercise trainingThe 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. |
| Sham Training | Sham comparator | Device: Sham TrainingThe 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric handgrip exercise trainingAlso: IHTMaximum 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. | Device | Isometric Handgrip Training |
| Sham TrainingEach cycle of sustained handgrip exercise consists of sustained squeezing of the hand dynamometer at 3 - 5% of MVC rather than 30%. | Device | Sham Training |
Primary outcome
Change in resting blood pressure (BP)
Time frame: Baseline, 8-weeks post-intervention
Resting BP will be recorded
Change in standard deviation BP variability
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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).
17 secondary outcomes
Change in 24-hour ambulatory BP monitoring (ABPM)
Time frame: Baseline, 8-weeks post-intervention
Change in resting muscle sympathetic nerve activity (MSNA)
Time frame: Baseline, 8-weeks post-intervention
Change in BP reactivity to cold pressor test (CPT)
Time frame: Baseline, 8-weeks post-intervention
Change in heart rate reactivity to cold pressor test (CPT)
Time frame: Baseline, 8-weeks post-intervention
Change in MSNA reactivity to cold pressor test (CPT)
Time frame: Baseline, 8-weeks post-intervention
Change in BP reactivity to handgrip exercise
Time frame: Baseline, 8-weeks post-intervention
Change in heart rate reactivity to handgrip exercise
Time frame: Baseline, 8-weeks post-intervention
Change in MSNA reactivity to handgrip exercise
Time frame: Baseline, 8-weeks post-intervention
Change in skeletal muscle oxygenation during handgrip exercise
Time frame: Baseline, 8-weeks post-intervention
Change in interstitial muscle pH during handgrip exercise
Time frame: Baseline, 8-weeks post-intervention
Change in cardiac baroreflex sensitivity
Time frame: Baseline, 8-weeks post-intervention
Change in sympathetic baroreflex sensitivity
Time frame: Baseline, 8-weeks post-intervention
Change in Inflammatory markers: C-Reactive Protein (CRP)
Time frame: Baseline, 8-weeks post-intervention
Change in Inflammatory markers: Interleukin-6 (IL-6)
Time frame: Baseline, 8-weeks post-intervention
Change in Inflammatory markers: endothelin
Time frame: Baseline, 8-weeks post-intervention
Change in Inflammatory markers: asymmetric dimethyl arginine (ADMA)
Time frame: Baseline, 8-weeks post-intervention
Change in Inflammatory markers: phospholipase A2 (PLA-2)
Time frame: Baseline, 8-weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeanie Park, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric handgrip exercise training in people with Chronic Kidney Diseases, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanie Park, MD (404-727-1386, jeanie.park@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting blood pressure (BP) (time frame: Baseline, 8-weeks post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.