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Behavioural Intervention

IMST for Chronic Kidney Disease and High Blood Pressure

N/A

Recruiting

Led By Michel Chonchol, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Significant pulmonary disorders including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma

History of hospitalization within the last month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Summary

This trial is testing a time-efficient lifestyle intervention to lower blood pressure in people with chronic kidney disease and high blood pressure.

Who is the study for?

Adults over 50 with moderate-to-severe chronic kidney disease and high blood pressure that's not well-controlled, despite being on stable medication for at least 6 weeks. Participants should be non-smokers, not have had recent hospitalizations or severe heart failure, and cannot be using immunosuppressants or have significant lung diseases.

What is being tested?

The trial is testing whether a type of breathing exercise called high-resistance inspiratory muscle strength training (IMST) can lower blood pressure and improve blood vessel function in older adults with kidney disease. It compares IMST to a sham training to see if it's effective.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from the breathing exercises or issues related to the use of equipment for those with certain pre-existing conditions like ear problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 50 and, if female, I am post-menopausal.

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I have moderate to severe kidney disease with stable kidney function in the last 3 months.

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My blood pressure has been between 120-159 mmHg despite medication for the last 6 weeks.

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My weight has been stable, with less than a 5% change in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious lung condition like COPD, lung scarring, cystic fibrosis, or severe asthma.

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I have been hospitalized within the last month.

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I have had a collapsed lung or burst eardrum that hasn't fully healed.

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I have been diagnosed with cancer.

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I have a history of severe heart failure.

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I am on chronic dialysis for advanced kidney disease.

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My doctor expects me to live more than a year despite my other health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Casual Systolic Blood Pressure

Secondary study objectives

Change in 24-Hour Ambulatory Systolic Blood Pressure

Change in Brachial Artery Flow-Mediated Dilation

Other study objectives

Adherence

Change in 24-Hour Ambulatory Diastolic Blood Pressure

Change in Casual Diastolic Blood Pressure

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IMSTExperimental Treatment1 Intervention

This group will perform high-resistance (75% of maximal inspiratory pressure) inspiratory muscle strength training (IMST), 30 inhalations/session, 6 days/week.

Group II: ControlPlacebo Group1 Intervention

This group will perform low-resistance (15% of maximal inspiratory pressure) inspiratory muscle strength training, 30 inhalations/session, 6 days/week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IMST

2010

Completed Phase 2

~80

0 / 11Eligibility criteria met