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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Casual Systolic Blood Pressure

Secondary outcome measures

Change in 24-Hour Ambulatory Systolic Blood Pressure

Change in Brachial Artery Flow-Mediated Dilation

Other outcome measures

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,418 Total Patients Enrolled

University of Colorado, BoulderOTHER

119 Previous Clinical Trials

29,086 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,484 Total Patients Enrolled

Media Library

IMST (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04911491 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in the cohort of this research endeavor?

"Affirmative. According to clinicaltrials.gov, this trial is still open for enrolment. It was first made public on March 1st 2022 and last modified on September 19th 2022. A total of 108 patients are required from one medical centre."

Answered by AI

Is this study seeking new participants?

"According to clinicaltrials.gov, the recruitment for this trial is ongoing. It was initially posted on March 1st 2022 and recently updated on September 19th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inspiratory Muscle Strength Training in Chronic Kidney Disease

2022. "Inspiratory Muscle Strength Training in Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04911491.

All > Chronic Kidney Disease > Hypertension