IMST for Chronic Kidney Disease and High Blood Pressure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
13678How 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.
23489Eligibility 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.
+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
+9 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Colorado - Anschutz Medical CampusAurora, CO
Loading ...
Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
University of Colorado, BoulderCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Inspiratory muscle training improves respiratory muscle strength, functional capacity and quality of life in patients with chronic kidney disease: a systematic review. [2019]Does inspiratory muscle training improve respiratory muscle strength, functional capacity, lung function and quality of life of patients with chronic kidney disease? Does inspiratory muscle training improve these outcomes more than breathing exercises?
Effects of inspiratory muscle training in patients with hypertension: a meta-analysis. [2023]To explore the effects of inspiratory muscle training (IMT) on hypertension and provide guidance for its clinical application as an auxiliary approach.
Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]Inspiratory muscle strength training (IMST) has been traditionally recommended for patients with chronic obstructive pulmonary disease (COPD) to improve respiratory strength. Respiratory strength is reduced as age increases. However, few studies have focused on the effects of IMST on older adults without COPD.
Effects of daily inspiratory muscle training on respiratory muscle strength and chest wall regional volumes in haemodialysis patients: a randomised clinical trial. [2021]Purpose: Evaluating the effects of interdialytic daily inspiratory muscle training (IMT) on respiratory muscle strength, chest wall regional volumes, diaphragmatic mobility and thickness, pulmonary function, functional capacity, and quality of life (QoL) in haemodialysis (HD) patients.Method: A randomised, and double-blind clinical trial composed of 24 chronic kidney disease patients undergoing HD. Patients were allocated into the IMT group (n = 12) or sham group (n = 12) and performed daily IMT twice per day with a load of 50% inspiratory muscle strength for the IMT group and 5 cmH2O for the sham group during 8 weeks. Respiratory muscle strength, diaphragm thickness and mobility, chest wall regional volumes, functional capacity, and QoL were measured.Results: At the end of the study, an increase in inspiratory and expiratory muscle strength was observed for both groups, but no significant difference was found between them. Changed volume distribution was also observed in the IMT group, with significantly increased inspiratory capacity in the pulmonary compartment compared to the sham group.Conclusions: Daily interdialytic IMT promoted a change in chest wall regional volumes, with an increase in the inspiratory capacity of the pulmonary rib cage. Both groups had increased inspiratory and expiratory muscle strength with daily respiratory exercise.Trial registration: www.ClinicalTrials.gov; study number: NCT02599987; name of trial registry: IMT in Patients with End-stage Renal Disease.Implications for rehabilitationMuscular impairment in chronic kidney disease patients results from a series of common alterations, affecting respiratory muscles.Patients with chronic kidney disease have low values of diaphragmatic thickness.The daily inspiratory muscle training (IMT) or breathing exercise over a period of 8 weeks provided increased respiratory muscle strength.The daily inspiratory muscle training presented a change in tri-compartment distribution of lung volume compared to the sham group, with increased inspiratory capacity of the pulmonary rib cage.
[Specific inspiratory muscle training in chronic hemodialysis]. [2006]Chronic renal failure can result in a variety of conditions leading to muscle weakness. We investigated inspiratory muscle (IM) performance and functional capacity in chronic renal failure before and after specific inspiratory muscle training (SIMT). 9 men and 1 woman, ranging in age from 22-78 years, while on chronic hemodialysis received SIMT 3 times a week, for 3 months, while 10 others received sham training. Static inspiratory pressures, IM endurance and functional capacity were reduced in most subjects. Following SIMT, IM performance improved significantly and was associated with improved functional capacity, but not in the control group. We conclude that patients with chronic renal failure undergoing maintenance hemodialysis have reduced IM performance, and SIMT improves functional capacity.
A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. [2023]Above-normal blood pressure (BP) is a primary risk factor for cardiovascular diseases. In a retrospective analysis of five pilot trials, we assessed the BP-lowering effects of high-resistance inspiratory muscle strength training (IMST) in adults aged 18-82 years and the impact of IMST on maximal inspiratory pressure (PIMAX), a gauge of inspiratory muscle strength and independent disease risk factor. Participants were randomized to high-resistance IMST (75% PIMAX) or low-resistance sham (15% PIMAX) training (30 breaths/day, 5-7 days/wk, 6 wk). IMST (n = 67) reduced systolic BP (SBP) by 9 ± 6 mmHg (P < 0.01) and diastolic BP (DBP) by 4 ± 4 mmHg (P < 0.01). IMST-related reductions in SBP and DBP emerged by week 2 of training (-4 ± 8 mmHg and -3 ± 6 mmHg; P ≤ 0.01, respectively) and continued across the 6-wk intervention. SBP and DBP were unchanged with sham training (n = 61, all P > 0.05). Select subject characteristics slightly modified the impact of IMST on BP. Greater reductions in SBP were associated with older age (β = -0.07 ± 0.03; P = 0.04) and greater reductions in DBP associated with medication-naïve BP (β = -3 ± 1; P = 0.02) and higher initial DBP (β = -0.12 ± 0.05; P = 0.04). PIMAX increased with high-resistance IMST and low-resistance sham training, with a greater increase from high-resistance IMST (+20 ± 17 vs. +6 ± 14 cmH2O; P < 0.01). Gains in PIMAX had a modest inverse relation with age (β = -0.20 ± 0.09; P = 0.03) and baseline PIMAX (β = -0.15 ± 0.07; P = 0.04) but not to reductions in SBP or DBP. These compiled findings from multiple independent trials provide the strongest evidence to date that high-resistance IMST evokes clinically significant reductions in SBP and DBP, and increases in PIMAX, in adult men and women.NEW & NOTEWORTHY In young-to-older adult men and women, 6 wk of high-resistance inspiratory muscle strength training lowers casual systolic and diastolic blood pressure by 9 mmHg and 4 mmHg, respectively, with initial reductions observed by week 2 of training. Given blood pressure outcomes with the intervention were only slightly altered by subject baseline characteristics (i.e., age, blood pressure medication, and health status), inspiratory muscle strength training is effective in lowering blood pressure in a broad range of adults.
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]Background High-resistance inspiratory muscle strength training (IMST) is a novel, time-efficient physical training modality. Methods and Results We performed a double-blind, randomized, sham-controlled trial to investigate whether 6 weeks of IMST (30 breaths/day, 6 days/week) improves blood pressure, endothelial function, and arterial stiffness in midlife/older adults (aged 50-79 years) with systolic blood pressure ≥120 mm Hg, while also investigating potential mechanisms and long-lasting effects. Thirty-six participants completed high-resistance IMST (75% maximal inspiratory pressure, n=18) or low-resistance sham training (15% maximal inspiratory pressure, n=18). IMST was safe, well tolerated, and had excellent adherence (≈95% of training sessions completed). Casual systolic blood pressure decreased from 135±2 mm Hg to 126±3 mm Hg (P<0.01) with IMST, which was ≈75% sustained 6 weeks after IMST (P<0.01), whereas IMST modestly decreased casual diastolic blood pressure (79±2 mm Hg to 77±2 mm Hg, P=0.03); blood pressure was unaffected by sham training (all P>0.05). Twenty-four hour systolic blood pressure was lower after IMST versus sham training (P=0.01). Brachial artery flow-mediated dilation improved ≈45% with IMST (P<0.01) but was unchanged with sham training (P=0.73). Human umbilical vein endothelial cells cultured with subject serum sampled after versus before IMST exhibited increased NO bioavailability, greater endothelial NO synthase activation, and lower reactive oxygen species bioactivity (P<0.05). IMST decreased C-reactive protein (P=0.05) and altered select circulating metabolites (targeted plasma metabolomics) associated with cardiovascular function. Neither IMST nor sham training influenced arterial stiffness (P>0.05). Conclusions High-resistance IMST is a safe, highly adherable lifestyle intervention for improving blood pressure and endothelial function in midlife/older adults with above-normal initial systolic blood pressure. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03266510.
Inspiratory muscle strength training in infants with congenital heart disease and prolonged mechanical ventilation: a case report. [2021]Inspiratory muscle strength training (IMST) has been shown to improve maximal pressures and facilitate ventilator weaning in adults with prolonged mechanical ventilation (MV). The purposes of this case report are: (1) to describe the rationale for IMST in infants with MV dependence and (2) to summarize the device modifications used to administer training.
Effects of inspiratory muscle training on pulmonary functions and muscle strength in sedentary hemodialysis patients. [2020][Purpose] This study was conducted to evaluate the effect of Inspiratory Muscle Trainer (IMT) on respiratory muscle strength and pulmonary functions. [Subjects and Methods] Fifteen sedentary unemployed patients were recruited from both genders who received regular hemodialysis sessions from at least three months. Those patients received Threshold IMT program for 12 weeks. Pulmonary functions and respiratory muscle strength in form of (PImax) and (PEmax) were measured by electronic spirometry and digital pressure vacuum meter respectively. Additionally oxygen saturation was measured by Finger pulse oximeter. All measurements were performed before and at the end of the treatment program after 12 weeks. [Results] The results of this study revealed significant improvement in FVC%, FEV1%, PEF%, PImax and PEmax after three months of treatment by using inspiratory muscle trainer while no significant difference was recorded regarding to FEV1/FVC% ratio and SpO2. [Conclusion] Inspiratory muscle trainer is an effective therapeutic technique to improve respiratory muscle strength and pulmonary functions in patients undergoing hemodialysis.