Inspiratory Muscle Strength Training for High Blood Pressure
Recruiting in Palo Alto (17 mi)
Overseen byDaniel H Craighead, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Boulder
Disqualifiers: Uncontrolled hypertension, Current smoker, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Above-normal systolic blood pressure (SBP), defined as SBP \>/= 120 mmHg, is the major modifiable risk factor for cardiovascular disease, stroke, cognitive decline/dementia, and other chronic health problems. Despite the availability of treatments to lower SBP, over 75 percent of adults with above-normal SBP fail to control BP, which has led to a nearly 50 percent increase in the number of deaths attributable to BP over the past decade. Therefore, above-normal SBP is a major public health burden.
* Greater than 65 percent of adults 50 years of age and older have above-normal SBP. The number of adults age 50 years and older is rapidly increasing, predicting a continued increase in above-normal SBP driven morbidity and mortality in the absence of effective treatment strategies. This makes developing novel SBP-lowering therapies an urgent biomedical research priority.
* Increasing SBP is closely linked to vascular dysfunction, observable as impaired endothelial function, increased large-elastic artery stiffness, and impaired cerebrovascular function. Declines in these functions play a large role in the increased risk of chronic disease associated with above-normal SBP. The primary mechanism responsible for SBP-induced vascular dysfunction is thought to be oxidative stress-associated inhibition of nitric oxide bioavailability. Therefore, to have the largest biomedical impact, new SBP-lowering therapies should also improve vascular function by decreasing oxidative stress.
* Healthy lifestyle practices, such as conventional aerobic exercise, maintaining a healthy diet, or reducing sodium intake, are all first-line strategies to lower SBP. Importantly, these lifestyle practices also improve vascular function, in large part by reducing oxidative stress. However, adherence to healthy lifestyle practices is poor, with adherence to guidelines generally between 20 to 40 percent in adult Americans. The greatest reported barrier to meeting healthy lifestyle guidelines is lack of time. Therefore, time-efficient interventions have great promise for promoting adherence, reducing SBP, and improving other physiological functions.
* High-resistance inspiratory muscle strength training (IMST) is a time-efficient (5 minutes per session) lifestyle intervention consisting of 30 inspiratory maneuvers performed against a high resistance. Preliminary data suggest 6-weeks of IMST performed 6 days/week reduces SBP by 9 mmHg in adults with above-normal SBP (i.e., greater than 120 mmHg) at baseline. Importantly, this reduction in SBP is equal to or greater than the reduction in blood pressure typically achieved with time- and effort-intensive healthy lifestyle strategies like conventional aerobic exercise. However, these results need to be confirmed in an appropriately powered clinical trial with a longer, guideline-based treatment duration. Furthermore, the influence of IMST on functions impaired by above-normal SBP (endothelial, cerebrovascular, cognitive) needs to be determined, as do the mechanisms through which IMST exerts beneficial effects.
* Accordingly, we will conduct a randomized, blinded, sham-controlled, parallel group design clinical trial to assess the efficacy of 3-months of IMST (75 percent maximal inspiratory pressure) vs. brisk walking (40-60% heart rate reserve; an established healthy lifestyle strategy) for lowering SBP and improving endothelial, cerebrovascular, and cognitive function in adults age 50 years and older with above-normal SBP. I hypothesize IMST will lower SBP and improve endothelial function by decreasing oxidative stress and increasing nitric oxide bioavailability. I also hypothesize IMST will improve cerebrovascular and cognitive function, and that these improvements will be related to reductions in SBP and improvements in endothelial function. I also expect adherence to the intervention to be excellent (over 80 percent of all training sessions completed at the appropriate intensity).
* To test my hypothesis, I will recruit 102 adults age 50 years and older who have SBP \>/= 120 mmHg. Subjects will undergo baseline testing for casual (resting) SBP, 24-hour ambulatory SBP, endothelial function, arterial stiffness, cognitive function, and cerebrovascular function. Innovative mechanistic probes including pharmaco-dissection with vitamin C, analysis of biopsied endothelial cells, and high-throughput metabolomics, will be performed to assess oxidative stress and nitric oxide bioavailability at baseline.
* After baseline testing, subjects will be randomized to perform either 3-months of high-resistance IMST or brisk walking. Subjects will train 6 days/week with one training session supervised in the laboratory and the other 5 performed unsupervised at home. Following 3 months of training, subjects will redo all the tests that were done during baseline testing to assess training-induced changes in SBP, physiological functions, and underlying mechanisms.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. In fact, participants must maintain their current medication regimen without changes during the study.
What data supports the effectiveness of the treatment Inspiratory Muscle Strength Training for High Blood Pressure?
Research shows that high-resistance inspiratory muscle strength training (IMST) can significantly lower blood pressure, with reductions in systolic blood pressure by 9 mmHg and diastolic blood pressure by 4 mmHg after six weeks of training. These improvements were observed in a wide range of adults, indicating that IMST is effective in lowering blood pressure.
12345Is inspiratory muscle strength training safe for humans?
Inspiratory muscle strength training (IMST) is generally safe and well-tolerated in humans, with studies showing high adherence and no significant adverse effects reported in both healthy and at-risk adults.
12678How does inspiratory muscle strength training differ from other treatments for high blood pressure?
Inspiratory muscle strength training (IMST) is unique because it involves breathing exercises that strengthen the muscles used for inhaling, which can lower blood pressure by improving respiratory endurance and reducing cardiovascular strain. Unlike traditional medications, this non-drug approach can be done at home with a simple device and has shown significant blood pressure reductions in just six weeks.
128910Eligibility Criteria
Adults aged 50 or older with high blood pressure (systolic BP of at least 120 mmHg), a BMI under 40, and stable weight are eligible for this trial. They must be non-smokers, not on changing medication regimens, able to consent, and have no history of uncontrolled hypertension or regular vigorous exercise.Inclusion Criteria
Your blood pressure when you are relaxed is 120 mmHg or higher.
I am healthy except for high blood pressure.
I haven't changed my medications or doses in the last 3 months and will keep them the same.
+6 more
Exclusion Criteria
I am under 50 years old.
Your blood pressure doesn't react normally during exercise, or it becomes very high during exercise.
You do intense aerobic exercise more than four times a week for at least 30 minutes each time.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Testing
Subjects undergo baseline testing for casual (resting) SBP, 24-hour ambulatory SBP, endothelial function, arterial stiffness, cognitive function, and cerebrovascular function.
1-2 weeks
1 visit (in-person)
Treatment
Participants perform either 3-months of high-resistance IMST or brisk walking. Subjects train 6 days/week with one training session supervised in the laboratory and the other 5 performed unsupervised at home.
12 weeks
12 visits (1 per week, in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including redo of all baseline tests to assess training-induced changes.
4 weeks
1 visit (in-person)
Participant Groups
The trial is testing whether a time-efficient breathing exercise called Inspiratory Muscle Strength Training (IMST) can lower systolic blood pressure more effectively than brisk walking. Participants will do one of these activities for three months to see if there's an improvement in blood pressure and vascular health.
2Treatment groups
Experimental Treatment
Active Control
Group I: Inspiratory muscle strength trainingExperimental Treatment1 Intervention
Using a handheld device, participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, six days a week, for three months.
Group II: Brisk walkingActive Control1 Intervention
Participants will walk for 25 minutes a day, six days a week, for three months at a target heart rate of 40-60% heart rate reserve. Heart rate will be monitored with a heart rate monitor.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Colorado BoulderBoulder, CO
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Who Is Running the Clinical Trial?
University of Colorado, BoulderLead Sponsor
References
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.
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.
Inspiratory muscle training in pulmonary arterial hypertension. [2015]The purpose of this study was to investigate the effects of inspiratory muscle training (IMT) on functional capacity, respiratory muscle strength, pulmonary function, quality of life, and fatigue and dyspnea perception in patients with pulmonary arterial hypertension (PAH).
Effects of inspiratory muscle training in patients with heart failure. [2011]To investigate the effects of inspiratory muscle training (IMT) on functional capacity and balance, respiratory and peripheral muscle strength, pulmonary function, dyspnea, fatigue, depression, and quality of life in heart failure patients.
Efficacy of inspiratory muscle training in chronic heart failure patients: a systematic review and meta-analysis. [2018]Inspiratory muscle training (IMT) offers an alternative to exercise training (ExT) in the most severely deconditioned heart failure patients who are unable to exercise. We conducted a meta-analysis to determine magnitude of change in peak VO2, six minute walk distance (6MWD), Quality of Life measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ), maximal inspiratory pressure (PI max) and ventilatory equivalent for carbon dioxide (VE/VCO2 slope) with IMT.
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.
Six Months of Inspiratory Muscle Training to Lower Blood Pressure and Improve Endothelial Function in Middle-Aged and Older Adults With Above-Normal Blood Pressure and Obstructive Sleep Apnea: Protocol for the CHART Clinical Trial. [2022]Background: Cardiovascular disease is a major global health concern and prevalence is high in adults with obstructive sleep apnea (OSA). Lowering blood pressure (BP) can greatly reduce cardiovascular disease risk and physical activity is routinely prescribed to achieve this goal. Unfortunately, many adults with OSA suffer from fatigue, daytime sleepiness, and exercise intolerance-due to poor sleep quality and nocturnal hypoxemia-and have difficulty initiating and maintaining an exercise program. High-resistance inspiratory muscle strength training (IMST) is a simple, time-efficient breathing exercise consistently reported to reduce BP in small, selective groups of both healthy and at-risk adults. Herein we present the study protocol for a randomized clinical trial to determine the long-term efficacy of IMST performed regularly for 24 weeks in middle-aged and older adults with OSA. The primary outcome is casual systolic BP. Secondary outcomes are 24-h systolic BP and circulating plasma norepinephrine concentration. Other outcomes include vascular endothelial function (endothelial-dependent and -independent dilation), aortic stiffness, casual and 24-h diastolic BP, and the influence of circulating factors on endothelial cell nitric oxide and reactive oxygen species production. Overall, this trial will establish efficacy of high-resistance IMST for lowering BP and improving cardiovascular health in middle-aged and older adults with OSA. Methods: This is a single-site, double-blind, randomized clinical trial. A minimum of 92 and maximum of 122 male and female adults aged 50-80 years with OSA and above-normal BP will be enrolled. After completion of baseline assessments, subjects will be randomized in a 1:1 ratio to participate in either high-resistance or sham (low-resistance) control IMST, performed at home, 5 min/day, 5 days/week, for 24 weeks. Repeat assessments will be taken after the 24-week intervention, and after 4 and 12 weeks of free living. Discussion: This study is designed to assess the effects of 24 weeks of IMST on BP and vascular function. The results will characterize the extent to which IMST can reduce BP when performed over longer periods (i.e., 6 months) than have been assessed previously. Additionally, this study will help to determine underlying mechanisms driving IMST-induced BP reductions that have been reported previously. Clinical Trial Registration: This trial is registered with ClinicalTrials.gov (Registration Number: NCT04932447; Date of registration June 21, 2021).
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.
Effectiveness and safety of inspiratory muscle training in patients with pulmonary hypertension: A systematic review and meta-analysis. [2022]Inspiratory muscle training (IMT) is a simple and well-tolerated physical therapy that increases respiratory muscle strength and relieving the degree of dyspnea and fatigue. Therefore, it may be used as a transitional modality before exercise training or as a specific physical therapy intervention for those who are diagnosed with respiratory muscle weakness. However, the current evidence on IMT in pulmonary hypertension (PH) patients is inconclusive. The purpose of this systematic review and meta-analysis was to summarize the current role of IMT in this group of patients.
A short course of high-resistance, low-volume breathing exercise extends respiratory endurance and blunts cardiovascular responsiveness to constant load respiratory testing in healthy young adults. [2023]Our objective was to evaluate the effects of 6-weeks high-resistance, low-volume inspiratory muscle strength training (IMST) on respiratory endurance, blood pressure (BP) and heart rate (HR) responsiveness to high respiratory workloads. Ten healthy young adults completed two constant-load resistive breathing tests to exhaustion (Tlim) (target pressure =65 % maximal inspiratory pressure [PImax]; duty cycle = 0.7; breathing frequency matched to eupnea) separated by 6-weeks high-resistance (75 % maximal inspiratory pressure, PImax), low-volume (30 inspiratory efforts/day, 5 days/week) IMST. Throughout resistive breathing trials we measured beat-to-beat changes in BP and HR, mouth pressure, inspiratory muscle work and perceived exertion. POST resistive breathing tests revealed significant gains in endurance (PRE: 362.0 ± 46.6 s vs. POST: 663.8 ± 110.3 s, p = 0.003) and increases in respiratory muscle work (PRE: -9445 ± 1562 mmHg.s vs. POST: -16648 ± 3761 mmHg.s, p = 0.069). Conversely, systolic and diastolic BP responses, HR and ratings of perceived exertion all declined. Consistent with previous observations, 6 weeks high resistance, low volume IMST lowered casual resting SBP (p = 0.002), DBP (p = 0.007) and mean arterial pressure (p = 0.001) and improved static inspiratory pressure. High resistance, low volume inspiratory muscle strength training extends respiratory endurance and attenuates BP responsiveness in healthy, recreationally-active young adults. The outcomes have implications for improved athletic performance and for attaining and/or maintaining cardiorespiratory fitness.