Inspiratory Muscle Strength Training in Chronic Kidney Disease

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.

Conditions

• Chronic Kidney Diseases
• Hypertension
• Aging
• Blood Pressure

Interventions

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.

Sponsors & Collaborators

• University of Colorado, Boulder

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Kristen Nowak, PhD, MPH · University of Colorado, Denver

• Michel Chonchol, MD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2026-07-01

Completion

2026-07-01

FDA Device

Yes

Countries

• United States

Study Locations