Inspiratory Muscle Strength Training in Chronic Kidney Disease
Recruiting · NCT04911491 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
2 locations listed across 1 US state.
- University of Colorado - Anschutz Medical Campus - Aurora, Colorado, United States
- University of Colorado - Anschutz Medical Campus - Aurora, Colorado, United States