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Inspiratory Muscle Strength Training in Chronic Kidney Disease

Recruiting · Aurora, Colorado

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Interpreters available

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Your choice

Voluntary — you can stop anytime

What is this study?

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.

It is , overseen by an independent and licensed medical staff.

Read the full clinical 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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • Age 50 or older (women must be post-menopausal).
  • Chronic kidney disease stage 3 or 4, with estimated kidney function (eGFR) between 20 and 59 mL/min/1.73m², and stable kidney function in the past 3 months.
  • History of inadequately controlled high blood pressure (systolic 120–159 mmHg on two separate days) and stable blood pressure medicine for the past 6 weeks.
  • Weight stable in the past 3 months (less than 2 kg change) and willing to keep weight stable during the study.
  • Able to provide informed consent.

🚫 You may not be able to join if…

  • Advanced chronic kidney disease that requires chronic dialysis.
  • Significant lung problems, including chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma.
  • Certain recent or unresolved lung/ear problems, including spontaneous pneumothorax, a collapsed lung that hasn’t fully healed, or a burst eardrum that hasn’t fully healed.
  • Severe heart failure history (ejection fraction <35%).
  • Current smoker, active illicit drug use, or alcohol dependence/abuse that would prevent following the study plan.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 50–any age
  • Have High blood pressure or Kidney disease
  • !Some conditions may not be a fit: Heart / cardiovascular disease, COPD (chronic lung disease), Asthma

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

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.

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT04911491 · Locations: Colorado