NCT04911491

Inspiratory Muscle Strength Training in Chronic Kidney Disease

Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure in Midlife and Older Adults With Chronic Kidney Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. Changes and cerebrovascular and cognitive function will be assessed as part of a sub-study.

Conditions

• Chronic Kidney Diseases
• Hypertension
• Aging
• Blood Pressure

Interventions

Type	Name	Description
DEVICE	IMST	Inspiratory muscle strength training (IMST) is a form of physical training that utilizes the diaphragm and accessory respiratory muscles to repeatedly inhale against resistance using a handheld device.
DEVICE	Sham Training	Repeated inhalations against a low resistance will be performed using a handheld device.

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2021-06-03
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study