108 Participants Needed

IMST for Chronic Kidney Disease and High Blood Pressure

BF
KN
EA
Overseen ByEmily Andrews
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable blood pressure medication regimen for at least 6 weeks before joining the study.

What data supports the effectiveness of the treatment IMST for Chronic Kidney Disease and High Blood Pressure?

Research shows that inspiratory muscle training (IMT) can improve respiratory muscle strength and functional capacity in patients with chronic kidney disease. Additionally, IMT has been found to have positive effects on high blood pressure, suggesting it may be a helpful treatment for these conditions.12345

Is inspiratory muscle strength training (IMST) safe for humans?

Research shows that high-resistance inspiratory muscle strength training (IMST) is safe and well-tolerated in adults, including those with high blood pressure. It has been used in various studies without significant safety concerns, making it a generally safe option for improving respiratory and cardiovascular health.13678

How is the treatment IMST different from other treatments for chronic kidney disease and high blood pressure?

IMST (Inspiratory Muscle Strength Training) is unique because it focuses on strengthening the muscles used for breathing, which can improve respiratory muscle strength and lung function. Unlike traditional treatments for high blood pressure and kidney disease, which often involve medication, IMST is a physical training method that can enhance breathing capacity and potentially improve quality of life.23489

What is the purpose of this trial?

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.

Research Team

MC

Michel B Chonchol, MD

Principal Investigator

University of Colorado, Denver

KN

Kristen Nowak, PhD, MPH

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Inclusion Criteria

I am over 50 and, if female, I am post-menopausal.
I have moderate to severe kidney disease with stable kidney function in the last 3 months.
My blood pressure has been between 120-159 mmHg despite medication for the last 6 weeks.
See 2 more

Exclusion Criteria

I have a serious lung condition like COPD, lung scarring, cystic fibrosis, or severe asthma.
You are currently smoking cigarettes.
Illicit drug use or alcohol dependence/abuse, which in the opinion of the investigators, would prohibit compliance with the study intervention
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inspiratory muscle strength training (IMST) or sham training for 3 months

12 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • IMST
  • Sham Training
Trial Overview 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.
Participant Groups
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.

IMST is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Inspiratory Muscle Strength Training for:
  • Chronic Kidney Disease
  • Hypertension
🇪🇺
Approved in European Union as Inspiratory Muscle Strength Training for:
  • Chronic Kidney Disease
  • Respiratory Muscle Weakness

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

University of Colorado, Boulder

Collaborator

Trials
128
Recruited
29,600+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

Inspiratory muscle training significantly improves respiratory muscle strength and functional capacity in patients with chronic kidney disease undergoing dialysis, as evidenced by increased maximal inspiratory pressure and improved performance on the 6-minute walk test.
Compared to breathing exercises, inspiratory muscle training also enhances lung function, specifically showing greater improvements in maximal expiratory pressure and forced expiratory volume in the first second (FEV1), although the overall quality of evidence is low due to methodological limitations in the studies reviewed.
Inspiratory muscle training improves respiratory muscle strength, functional capacity and quality of life in patients with chronic kidney disease: a systematic review.de Medeiros, AIC., Fuzari, HKB., Rattesa, C., et al.[2019]
Inspiratory muscle training (IMT) significantly reduces systolic blood pressure (SBP) by an average of 12.55 mmHg and diastolic blood pressure (DBP) by 4.77 mmHg in patients with hypertension, based on a meta-analysis of 8 randomized controlled trials involving 215 patients.
Low-intensity IMT is particularly effective, showing greater reductions in both SBP and DBP compared to medium-high-intensity IMT, suggesting it could be a valuable auxiliary treatment for managing hypertension.
Effects of inspiratory muscle training in patients with hypertension: a meta-analysis.Zheng, S., Zhang, Q., Li, S., et al.[2023]
Inspiratory muscle strength training (IMST) significantly increases maximal inspiratory pressure and reduces dyspnea in both older adults without COPD and those with COPD, demonstrating its efficacy as a respiratory intervention.
IMST particularly enhances functional status and quality of life in older adults without COPD, suggesting that this training can benefit a broader population beyond just COPD patients.
Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease.Huang, CH., Yang, GG., Wu, YT., et al.[2016]

References

Inspiratory muscle training improves respiratory muscle strength, functional capacity and quality of life in patients with chronic kidney disease: a systematic review. [2019]
Effects of inspiratory muscle training in patients with hypertension: a meta-analysis. [2023]
Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]
Effects of daily inspiratory muscle training on respiratory muscle strength and chest wall regional volumes in haemodialysis patients: a randomised clinical trial. [2021]
[Specific inspiratory muscle training in chronic hemodialysis]. [2006]
A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. [2023]
Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. [2022]
Inspiratory muscle strength training in infants with congenital heart disease and prolonged mechanical ventilation: a case report. [2021]
Effects of inspiratory muscle training on pulmonary functions and muscle strength in sedentary hemodialysis patients. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security