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


Description

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.Chronic kidney disease (CKD) is a major public health concern that has reached epidemic propo

Trial Eligibility

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 (\<5% weight change) and willing to remain weight stable throughout the study * 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 Info

Organization

University of Colorado, Denver


Primary Outcome

Change in Casual Systolic Blood Pressure


Outcome Timeframe Baseline, 3 months

NCTID NCT04911491

Phases NA

Primary Purpose TREATMENT

Start Date 2022-03-01

Completion Date 2026-07-01

Enrollment Target 108

Interventions

DEVICE IMST

DEVICE Sham Training

Locations Recruiting

University of Colorado - Anschutz Medical Campus

United States, Colorado, Aurora


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