Handgrip Exercise Training and CKD

NCT07094906 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00009157
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Chronic Kidney Diseases

Keywords

Handgrip; Isometric handgrip exercise training (IHT); Blood pressure variability

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (17)

• 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

Study Arms (2)

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.

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.

Device: Sham Training

Interventions

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.

Also known as: IHT

Isometric Handgrip Training

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%.

Sham Training

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• American Heart Association: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeanie Park, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanie Park, MD

CONTACT

404-727-1386; jeanie.park@emory.edu

Fatima Kamal

CONTACT

404-727-3717; fatima.kamal@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 31, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: 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.

Locations

US (1)