RECRUITING

Inspiratory Muscle Strength Training in Chronic Kidney Disease

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Conditions

Chronic Kidney DiseasesHypertensionAgingBlood Pressure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-01
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04911491

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 50 years or older; women must be post-menopausal
  2. * 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)
  3. * 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
  4. * Weight stable in the prior 3 months (\<5% weight change) and willing to remain weight stable throughout the study
  5. * Ability to provide informed consent
  1. * Patients with advanced chronic kidney disease requiring chronic dialysis
  2. * Significant pulmonary disorders including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma
  3. * 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
  4. * Significant co-morbid conditions with a life expectancy of \< 1 year
  5. * History of severe congestive heart failure (i.e., ejection fraction \<35%)
  6. * History of hospitalization within the last month
  7. * Albuminuria (albumin to creatinine ratio \> 2200 mg/g
  8. * Current smoker
  9. * 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)
  10. * Known malignancy
  11. * 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)
  12. * Illicit drug use or alcohol dependence/abuse, which in the opinion of the investigators, would prohibit compliance with the study intervention

Contacts and Locations

Study Contact

Kristen Nowak, PhD, MPH
CONTACT
303-724-4842
Kristen.Nowak@cuanschutz.edu
Emily Andrews
CONTACT
303-724-7790

Principal Investigator

Kristen Nowak, PhD, MPH
PRINCIPAL_INVESTIGATOR
University of Colorado - Anschutz Medical Campus
Michel Chonchol, MD
PRINCIPAL_INVESTIGATOR
University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Kristen Nowak, PhD, MPH, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus
  • Michel Chonchol, MD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

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

Study Start Date2022-03-01
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Diseases
  • Hypertension
  • Aging
  • Blood Pressure