IMST for Chronic Kidney Disease and High Blood Pressure

Overseen By Emily Andrews

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Antihypertensives

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Advanced kidney disease, Pulmonary disorders, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

108 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{1 4 7 8 9}

Who Is on the Research Team?

Michel B Chonchol, MD

Principal Investigator

University of Colorado, Denver

Kristen Nowak, PhD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: IMST Experimental Treatment 1 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: Control Placebo Group 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 24 chronic kidney disease patients undergoing hemodialysis, daily inspiratory muscle training (IMT) for 8 weeks led to significant changes in chest wall regional volumes, particularly increasing the inspiratory capacity of the pulmonary rib cage compared to a sham group.

Both the IMT and sham groups showed improvements in inspiratory and expiratory muscle strength, indicating that while IMT was effective in altering lung volume distribution, it did not significantly outperform the sham intervention in terms of muscle strength gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of daily inspiratory muscle training on respiratory muscle strength and chest wall regional volumes in haemodialysis patients: a randomised clinical trial. Medeiros, AIC., Brandão, DC., Souza, RJP., et al.[2021]

In a study of 10 patients with chronic renal failure undergoing hemodialysis, specific inspiratory muscle training (SIMT) significantly improved inspiratory muscle performance and functional capacity over 3 months.

The control group that received sham training did not show any improvements, highlighting the efficacy of SIMT in enhancing muscle strength and overall function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Specific inspiratory muscle training in chronic hemodialysis]. Weiner, P., Ganem, R., Zamir, D., et al.[2006]

High-resistance inspiratory muscle strength training (IMST) significantly lowers systolic blood pressure (SBP) by 9 mmHg and diastolic blood pressure (DBP) by 4 mmHg in adults over 6 weeks, with effects noticeable as early as week 2.

IMST also improves inspiratory muscle strength, as indicated by increased maximal inspiratory pressure (PIMAX), and is effective across a wide range of adult ages and health statuses, making it a promising intervention for managing blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. Craighead, DH., Tavoian, D., Freeberg, KA., et al.[2023]

High-resistance inspiratory muscle strength training (IMST) over 6 weeks significantly reduced systolic blood pressure in midlife and older adults, with effects lasting for at least 6 weeks after the training ended.

IMST also improved endothelial function, as shown by a 45% increase in brachial artery flow-mediated dilation, indicating its potential as a safe and effective intervention for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Craighead, DH., Heinbockel, TC., Freeberg, KA., et al.[2022]

Inspiratory muscle strength training (IMST) was successfully adapted for two infants with congenital heart disease, leading to improved inspiratory muscle performance and successful weaning from mechanical ventilation without any adverse events.

Both infants showed significant improvements in maximal inspiratory pressure and breathing patterns, allowing them to transition to high-flow nasal cannula without needing reintubation during their hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle strength training in infants with congenital heart disease and prolonged mechanical ventilation: a case report. Smith, BK., Bleiweis, MS., Neel, CR., et al.[2021]

The study involved 15 sedentary patients undergoing hemodialysis who used an Inspiratory Muscle Trainer (IMT) for 12 weeks, resulting in significant improvements in respiratory muscle strength and pulmonary functions, including FVC%, FEV1%, PEF%, PImax, and PEmax.

Despite the improvements in respiratory metrics, there was no significant change in the FEV1/FVC% ratio or oxygen saturation levels, indicating that while IMT enhances certain aspects of respiratory function, it may not affect all pulmonary parameters equally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of inspiratory muscle training on pulmonary functions and muscle strength in sedentary hemodialysis patients. El-Deen, HAB., Alanazi, FS., Ahmed, KT.[2020]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves respiratory muscle strength, functional capacity and quality of life in patients with chronic kidney disease: a systematic review. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of inspiratory muscle training in patients with hypertension: a meta-analysis. [2023]

3. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Effects of daily inspiratory muscle training on respiratory muscle strength and chest wall regional volumes in haemodialysis patients: a randomised clinical trial. [2021]

5. Israel pubmed.ncbi.nlm.nih.gov

[Specific inspiratory muscle training in chronic hemodialysis]. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle strength training in infants with congenital heart disease and prolonged mechanical ventilation: a case report. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

Effects of inspiratory muscle training on pulmonary functions and muscle strength in sedentary hemodialysis patients. [2020]