Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT04911491

Inspiratory Muscle Strength Training in Chronic Kidney Disease

Led by University of Colorado, Denver · Updated on 2025-05-02

108

Participants Needed

1

Research Sites

226 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

U

University of Colorado, Boulder

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Inspiratory Muscle Strength Training in Chronic Kidney Disease

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 50 years or older; women must be post-menopausal
  • Chronic kidney disease stage 3 or 4 with stable renal function over the past 3 months (eGFR 20-59 mL/min/1.73m²)
  • History of inadequately controlled hypertension with systolic blood pressure between 120-159 mmHg on two separate days
  • On a stable antihypertensive medication regimen for at least 6 weeks
  • Weight stable within 2 kg in the prior 3 months and willing to maintain stable weight throughout the study
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • 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, traumatic lung injury not fully healed, or unresolved burst eardrum
  • Significant co-morbid conditions with life expectancy less than 1 year
  • History of severe congestive heart failure with ejection fraction less than 35%
  • Hospitalization within the last month
  • Albuminuria with albumin to creatinine ratio over 2200 mg/g
  • Current smoker
  • Use of immunosuppressant agents in the past 12 months (except certain steroids for gout; no steroids within 14 days before vascular testing)
  • Known malignancy
  • Inability to cooperate with or contraindications for MRI including severe claustrophobia, implants, devices, or non-removable body piercings (excluded only from MRI procedure)
  • Illicit drug use or alcohol dependence/abuse that would prevent study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

K

Kristen Nowak, PhD, MPH

CONTACT

E

Emily Andrews

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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