No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
50 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
108 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for older adults with chronic kidney disease and high blood pressure. Participants will do a special breathing exercise program to see if it helps lower blood pressure.
I have been stable on my blood pressure medications for 6 weeks.
I have not changed my weight by more than 2 kg in the last 3 months.
I can give my consent to participate.
You may not be able to join if
I need dialysis for my kidney disease.
I have a serious lung disease.
I have had a spontaneous pneumothorax or an unhealed injury to my lung or ear.
I have a serious health condition that limits my life expectancy.
I have severe heart failure.
I was hospitalized in the last month.
I smoke.
I have taken immunosuppressant drugs in the last 12 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 interventi…
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.
Trial Locations
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Eligibility Criteria
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…
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
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