Recruiting

Inspiratory Muscle Strength Training

Sponsor:

University of Colorado, Denver

Code:

NCT04911491

Conditions

Chronic Kidney Diseases

Hypertension

Aging

Blood Pressure

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

IMST

Sham Training

Study Details

Brief 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

Study ID

NCT04911491

Start date

Mar 1, 2022

Status verified date

Apr, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with advanced chronic kidney disease requiring chronic dialysis
  • Significant pulmonary disorders including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma
  • History of spontaneous pneumothorax, collapsed lung due to traumatic injury that has not fully healed, burst eardrum that has not fully healed, or other conditions of the eardrum
  • Significant co-morbid conditions with a life expectancy of < 1 year
  • History of severe congestive heart failure (i.e., ejection fraction <35%)
  • History of hospitalization within the last month
  • Albuminuria (albumin to creatinine ratio > 2200 mg/g
  • Current smoker
  • Immunosuppressant agents taken in the past 12 months. Steroids used for the treatment of gout are acceptable; however, patients should not be using steroids within 2 weeks (or 14 days) prior to the vascular testing (rationale: may confound vascular testing)
  • Known malignancy
  • Inability to cooperate with or clinical contraindication for magnetic resonance imaging including: severe claustrophobia, implants, devices, or non-removable body piercings (these individuals can participate in the study but are excluded from the MRI procedure)
  • Illicit drug use or alcohol dependence/abuse, which in the opinion of the investigators, would prohibit compliance with the study intervention

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Sham Training

Repeated inhalations against a low resistance will be performed using a handheld device.

Primary outcome measure

  • Change in Casual Systolic Blood Pressure [ Time Frame: Baseline, 3 months ]

Central Contacts and Locations

Central contacts

Kristen Nowak, PhD, MPH

303-724-4842Kristen.Nowak@cuanschutz.edu

Emily Andrews

303-724-7790

Locations

University of Colorado - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kristen Nowak, PhD, MPH

303-724-4842Kristen.Nowak@cuanschutz.edu

Emily Andrews

303-724-7790Emily.S.Andrews@cuanschutz.edu

Principal Investigator:

Kristen Nowak, PhD, MPH

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 2, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-05-02.