Inspiratory Muscle Strength Training in Chronic Kidney Disease

Status Recruiting

Clinical Trial Summary

More than 80% of individuals with chronic kidney disease have concomitant hypertension and the majority fail to achieve blood pressure control <130/80 mmHg, leading to high risk of cardiovascular diseases and end-stage kidney disease. A stepwise combination of lifestyle modifications and drug therapy is recommended to lower blood pressure; however, adherence to time-intensive lifestyle interventions such as aerobic exercise in patients with chronic kidney disease is poor. This clinical trial seeks to establish the efficacy of high-resistance inspiratory muscle strength training, a novel time-efficient lifestyle intervention, for lowering systolic blood pressure and improving endothelial function in midlife and older adults with moderate-to-severe chronic kidney disease and inadequately controlled hypertension, and to use innovate translational assessments to understand the mechanisms involved.

Clinical Trial Description

Chronic kidney disease (CKD) is a major public health concern that has reached epidemic proportions. Hypertension is a leading modifiable risk factor for cardiovascular disease (CVD) and end-stage kidney disease, yet 50-70% of adults with CKD fail to achieve blood pressure (BP) control to <130/80 mmHg. A key process linking high systolic BP (SBP) to CVD is vascular endothelial dysfunction, which is due in part to increased reactive oxygen species and decreased nitric oxide. Nitric oxide is also critical in the regulation of renal blood flow, which is intimately related to blood pressure and vascular function. High-resistance inspiratory muscle strength training (IMST) is a novel lifestyle intervention involving repeated inhalations against a resistive load using a hand-held device. This study will test whether high-resistance IMST (75% of maximal inspiratory pressure [75% PImax]; 30 breaths [5 min]/day, 6 days [30 min]/week) vs. Sham training (15% PImax) reduces resting systolic blood pressure in midlife and older adults (>50 years) with moderate-to-severe CKD and inadequately controlled hypertension. Changes in 24-hr systolic blood pressure and endothelial function (brachial artery flow-mediated dilation) are secondary outcomes. Innovative translational techniques will be used to provide mechanistic insight, including serum incubation in endothelial cell culture, metabolomics analysis, endothelial cell collections, and assessment of renal blood flow by magnetic resonance imaging. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04911491
Study type	Interventional
Source	University of Colorado, Denver
Contact	Kristen Nowak, PhD, MPH
Phone	303-724-4842
Email	Kristen.Nowak@cuanschutz.edu
Status	Recruiting
Phase	N/A
Start date	March 1, 2022
Completion date	July 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04591808` - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia	Phase 3
Recruiting	`NCT04515303` - Digital Intervention Participation in DASH
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Completed	`NCT03093532` - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT05529147` - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting	`NCT05976230` - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed	`NCT06008015` - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers	Phase 1
Completed	`NCT05387174` - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period	N/A
Completed	`NCT04082585` - Total Health Improvement Program Research Project
Recruiting	`NCT05121337` - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension	N/A
Withdrawn	`NCT04922424` - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men	Phase 1
Active, not recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Completed	`NCT05087290` - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting	`NCT05038774` - Educational Intervention for Hypertension Management	N/A
Completed	`NCT05621694` - Exploring Oxytocin Response to Meditative Movement	N/A
Completed	`NCT05688917` - Green Coffee Effect on Metabolic Syndrome	N/A
Recruiting	`NCT05575453` - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure	N/A