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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Aged 50 years or older; women must be post-menopausal

• Chronic kidney disease stage 3 or 4 (estimated glomerular filtration rate with the 4 CKD-EPI 2021 race-free equation: 20-59 mL/min/1.73m\^2; stable renal function in the past 3 months)

• History of inadequately controlled hypertension (systolic blood pressure 120-159 mmHg on two separate days) and on a stable antihypertensive regimen for the past 6 weeks

• Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study. Participants using glucagon-like peptide-1 receptor agonists or planning to start them during the study are excluded unless they have achieved weight stability for at least 3 months prior to enrollment.

• Ability to provide informed consent

Locations
United States
Colorado
University of Colorado - Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Kristen Nowak, PhD, MPH
Kristen.Nowak@cuanschutz.edu
303-724-4842
Backup
Emily Andrews
303-724-7790
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 108
Treatments
Experimental: IMST
This group will perform high-resistance (75% of maximal inspiratory pressure) inspiratory muscle strength training (IMST), 30 inhalations/session, 6 days/week.
Sham_comparator: Control
This group will perform low-resistance (15% of maximal inspiratory pressure) inspiratory muscle strength training, 30 inhalations/session, 6 days/week.
Authors
Kristen Nowak
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Boulder
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov