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Inspiratory Muscle Strength Training for High Blood Pressure
N/A
Recruiting
Led By Daniel H Craighead, PhD
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 50 years and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will test whether a time-efficient intervention, high-resistance inspiratory muscle strength training, can lower blood pressure and improve endothelial, cerebrovascular, and cognitive function in adults with above-normal blood pressure.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from the interventions may include muscle soreness from IMST or typical exercise-related discomfort such as joint pain or fatigue from brisk walking.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in resting systolic and diastolic blood pressure
Secondary outcome measures
Change from baseline endothelial function at 3 months
Other outcome measures
Change from baseline ambulatory systolic and diastolic blood pressure at 3 months
Change from baseline in aortic stiffness at 3 months
Change from baseline in cerebrovascular reactivity at 3 months
+12 moreTrial Design
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.
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Who is running the clinical trial?
University of Colorado, BoulderLead Sponsor
119 Previous Clinical Trials
29,092 Total Patients Enrolled
Daniel H Craighead, PhDPrincipal InvestigatorUniversity of Colorado, Boulder
2 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 50 years old.Your blood pressure when you are relaxed is 120 mmHg or higher.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.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.My weight has been stable, with less than a 2 kg change, for the last 3 months.Your body mass index is less than 40.You are currently smoking cigarettes.I am 50 years old or older.My blood pressure is not higher than 180/120 mmHg.You need to score 24 or higher on a test that checks your memory and thinking skills.
Research Study Groups:
This trial has the following groups:- Group 1: Inspiratory muscle strength training
- Group 2: Brisk walking
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest population of people taking part in this clinical experiment?
"Affirmative, the data hosted on clinicaltrials.gov illustrates that this medical trial is presently looking for participants. The initial posting of this study was made on May 7th 2021 and it has recently been updated on November 8th 2022. 102 patients are sought from a single site."
Answered by AI
Are participants being welcomed for this investigation currently?
"According to the information published on clinicaltrials.gov, this medical trial is currently recruiting participants. This study was initially posted on May 7th 2021 with its most recent update occurring November 8th 2022."
Answered by AI
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