Inspiratory Muscle Strength Training in Chronic Kidney Disease
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 Start (Actual) 1 March 2022
🗓️ Primary Completion (Estimated) 1 July 2026
✅ Study Completion (Estimated) 1 July 2026
👥 Enrollment (Estimated) 108
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 50 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 May 2021
  • First Submitted that Met QC Criteria 27 May 2021
  • First Posted 3 June 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 September 2023
  • Last Update Posted 28 September 2023
  • Last Verified September 2023