High-resistance inspiratory muscle training for managing blood pressure in chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of high-resistance inspiratory muscle strength training (IMST) as a time-efficient intervention for lowering systolic blood pressure in midlife and older adults with moderate-to-severe chronic kidney disease and inadequately controlled hypertension. Participants will engage in daily IMST sessions using a hand-held device, comparing results against a sham training group. The study aims to assess changes in blood pressure and endothelial function, while also exploring the underlying mechanisms through innovative translational assessments. The goal is to provide a feasible alternative to traditional lifestyle modifications that often see poor adherence in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado - Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Kristen Nowak, PhD, MPH — University of Colorado, Denver
• Study coordinator: Kristen Nowak, PhD, MPH
• Email: Kristen.Nowak@cuanschutz.edu
• Phone: 303-724-4842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.