Inspiratory muscle strength training for Hypertension

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Colorado Boulder, Boulder, CO
Hypertension+3 More
Inspiratory muscle strength training - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Novel Time-efficient Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure

See full description

Eligible Conditions

  • Hypertension
  • Blood Pressures
  • Endothelial Dysfunction

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Inspiratory muscle strength training will improve 1 primary outcome, 1 secondary outcome, and 15 other outcomes in patients with Hypertension. Measurement will happen over the course of 3 months.

3 months
Change from baseline ambulatory systolic and diastolic blood pressure at 3 months
Change from baseline endothelial function at 3 months
Change from baseline in aortic stiffness at 3 months
Change from baseline in cerebrovascular reactivity at 3 months
Change from baseline in cognitive function at 3 months
Change from baseline in endothelial cell antioxidant defenses at 3 months
Change from baseline in endothelial cell nitric oxide production at 3 months
Change from baseline in endothelial cell oxidative stress at 3 months
Change from baseline in endothelial cell pro-oxidant signaling at 3 months
Change from baseline in endothelial cell superoxide production at 3 months
Change from baseline in internal carotid artery endothelial function at 3 months
Change from baseline in oxidative stress-associated suppression of endothelial function at 3 months
Change from baseline in oxidative stress-mediated suppression of cerebrovascular reactivity at 3 months
Change from baseline in oxidative stress-mediated suppression of internal carotid artery endothelial function at 3 months
Change from baseline in plasma concentrations of L-arginine, a substrate for nitric oxide, at 3 months
Change from baseline in plasma concentrations of dehydroascorbate, an antioxidant, at 3 months
Change from baseline in resting systolic and diastolic blood pressure

Trial Safety

Trial Design

2 Treatment Groups

Brisk walking
1 of 2
Inspiratory muscle strength training
1 of 2
Active Control
Experimental Treatment

This trial requires 102 total participants across 2 different treatment groups

This trial involves 2 different treatments. Inspiratory Muscle Strength Training is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Inspiratory muscle strength training
Other
Using a handheld device, participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, six days a week, for three months.
Brisk walking
Other
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Who is running the study

Principal Investigator
D. S.
Prof. Douglas Seals, Distinguished Professor
University of Colorado, Boulder

Closest Location

University of Colorado Boulder - Boulder, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
An individual's mini-mental state exam (MMSE) score is 24 or higher if their score falls between 24 and 30 on the MMSE scale show original
The person has not changed their blood pressure medications or any other medications in the past 3 months and is willing to continue taking the same medications. show original
is a basic human right, says UN The UN says that the ability to provide informed consent is a basic human right. show original
I am willing to be randomly assigned to a condition. show original
People aged 50 years and older are at an increased risk for developing heart disease. show original
Meaning that a person's systolic blood pressure when they are resting is 120 mmHg or greater. show original
The person has a body mass index of less than 40 kg/m2. show original
The person is weight stable in the past three months and is willing to remain weight stable throughout the study. show original
, this 42-year-old woman has a normal physical examination and a normal chest radiograph This 42-year-old woman is free from clinical disease with the exception of hypertension show original

Patient Q&A Section

What are the signs of respiratory aspiration?

"Signs of respiratory aspiration may be present in children under the age of 5 years. The patient should be instructed on coughing or sneezing in order to make an appropriate swallowing effort to clear the mouth during an apnoeic episode." - Anonymous Online Contributor

Unverified Answer

How many people get respiratory aspiration a year in the United States?

"There is a high prevalence of respiratory aspiration in this population, and this population can sustain respiratory aspiration and associated consequences such as chronic pulmonary disease, hospitalizations, and increased morbidity." - Anonymous Online Contributor

Unverified Answer

What is respiratory aspiration?

"Respiratory aspiration occurs when a foreign object lodge within the larynx or pharynx and obstructs airflow. It most commonly occurs following surgery, but it may also occur through laryngomalacia, intubation, or penetrating head injuries. Respiratory aspiration is a major hospital complication following surgical airway procedures. Treatment is based on a multidisciplinary approach, with appropriate physiotherapy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for respiratory aspiration?

"Respiratory aspiration is a common medical condition, and patients undergoing surgery often require various treatments. Ventilator assisted respiration (VAR), and continuous positive airway pressure (CPAP) are common treatments for this disorder. VAR consists of using a machine to help maintain airway patency and oxygenation in patients who are not breathing on their own. VAR has been shown to improve respiratory outcomes when compared with standard ventilation alone. VAR is often utilized in patients with altered mental status, to help reduce the risk of further aspiration and reduce the need for tracheostomy tube placement. VAR is also used for other reasons." - Anonymous Online Contributor

Unverified Answer

Can respiratory aspiration be cured?

"Respiratory aspiration of aspiration of air into the sphincter does not always have to be fatal unless the volume of the aspiration is larger. A low index inspiratory pressure may reduce aspiration. In the future, mechanical devices to prevent aspiration may be used." - Anonymous Online Contributor

Unverified Answer

What causes respiratory aspiration?

"Respiratory symptoms that are unexplained for a period of 2 weeks to several months may be diagnosed as aspiration if the suspicion is raised when a person experiences shortness of breath. In the elderly, medical complications of dysphagia such as respiratory failure may occur or be masked." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets respiratory aspiration?

"There is no average age of people getting respiratory aspiration. Instead, age is most often associated with postoperative respiratory distress which means a person will breathe a lot when they awaken." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in inspiratory muscle strength training for therapeutic use?

"The most effective exercises in IM training use a combination of exercises. Exercises for IM training must take into account the muscle mass and composition of the patient. In addition, IM training exercises in the form of progressive resistance training should be developed." - Anonymous Online Contributor

Unverified Answer

Is inspiratory muscle strength training typically used in combination with any other treatments?

"In this cohort who received treatment at a PFT clinic, inspiratory muscle strength training was used as part of a wider treatment program. It was not used as part of rehabilitation. Inspiratory muscle strength training should be added to rehabilitation protocols if a patient's muscle strength is impaired. No relationship was found between inspiratory muscle strength training and inspiratory lung volumes." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving inspiratory muscle strength training?

"The study of IMI using a variety of approaches has allowed researchers to determine the relative benefits of various training loads. Additionally, there is evidence for the benefits of high-intensity IMI training at the submaximal loads associated with inspiratory muscle weakness in patients after thoracic surgery and with respiratory failure." - Anonymous Online Contributor

Unverified Answer

What is the latest research for respiratory aspiration?

"A growing literature exists on the treatment of respiratory aspiration and aspiration pneumonia in critically ill and very frail patients with and without dysphagia. However, few randomized clinical trials have been conducted to test the safety and efficacy of agents administered for this indication. Additional research is needed to determine optimal treatment of aspiration." - Anonymous Online Contributor

Unverified Answer

What is inspiratory muscle strength training?

"Contrary to popular belief, MVC improves at a higher rate than at a quicker rate during IMS. More importantly, IMS is an important consideration with regard to the rate of increase in MVC." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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