Handgrip Exercise Training and CKD
ConditionChronic Kidney Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Severe CKD (eGFR<15 cc/minute)
Metabolic alkalosis (serum bicarbonate > 28 meq/L)
Ongoing drug or alcohol abuse
Diabetic neuropathy
Trial design
Design model
Parallel
Treatments tested in this trial
Isometric handgrip exercise training
DeviceMaximum 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 Training
DeviceEach cycle of sustained handgrip exercise consists of sustained squeezing of the hand dynamometer at 3 - 5% of MVC rather than 30%.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Isometric Handgrip TrainingExperimental treatment 1 intervention
Group B: Sham TrainingSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in resting blood pressure (BP)
Resting BP will be recorded
Time frame
Baseline, 8-weeks post-intervention2
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
Time frame
Baseline, 8-weeks post-intervention3
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.
Time frame
Baseline, 8-weeks post-intervention4
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.
Time frame
Baseline, 8-weeks post-interventionSecondary outcomes
1
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.
Time frame
Baseline, 8-weeks post-intervention2
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).
Time frame
Baseline, 8-weeks post-intervention3
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.
Time frame
Baseline, 8-weeks post-intervention4
Change in heart rate reactivity to cold pressor test (CPT)
Heart rate reactivity to the CPT in beats per minute will be recorded.
Time frame
Baseline, 8-weeks post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov
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