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Inspiratory Training for Respiratory Aspiration (REVIRT Trial)
N/A
Waitlist Available
Led By Dallin Tavoian, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight stable in the prior 3 months (<3.0 kg weight change) and willing to remain weight stable throughout the study
50+ years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cvr will be assessed after 6 weeks of training and after an additional 12 weeks of training
Awards & highlights
REVIRT Trial Summary
This trial will study how much exercise is needed to keep heart healthy after an initial 6 week training program.
Who is the study for?
This trial is for individuals over 50 with stable high blood pressure (120-169 mmHg systolic), not experiencing major weight changes, and on a consistent medication dose. Participants must own a smartphone. Excluded are smokers, those with certain respiratory or cardiovascular conditions, extreme obesity (BMI ≥ 40 kg/m2), recent serious heart events, regular intense exercisers, pregnant women, and people on specific medications.Check my eligibility
What is being tested?
The study examines the necessary dosage of inspiratory muscle strength training to maintain heart health improvements gained from an initial six-week intensive training period. It's focused on how much exercise keeps up the benefits.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include discomfort or fatigue from breathing exercises and possible strain-related injuries if not performed correctly.
REVIRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My weight has been stable for the last 3 months and I can keep it stable during the study.
Select...
I am 50 years old or older.
REVIRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ blood pressure will be assessed at baseline and after 6 weeks of training
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood pressure will be assessed at baseline and after 6 weeks of training
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 to endpoint 1 (6 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)
Change from baseline to endpoint 1 (6 weeks) resting systolic blood pressure
Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)
+1 moreSecondary outcome measures
Change from baseline to endpoint 1 (6 weeks) cerebrovascular reactivity (CVR)
Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks)
REVIRT Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: IMST 3 days/weekExperimental Treatment1 Intervention
30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, for 6 weeks, then 30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 3 days/week, for 12 weeks.
Group II: IMST 1 day/weekExperimental Treatment1 Intervention
30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, for 6 weeks, then 30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 1 day/week, for 12 weeks.
Group III: ControlActive Control1 Intervention
30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, for 6 weeks, then no exercise for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inspiratory muscle strength training
2018
N/A
~160
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,235 Total Patients Enrolled
American Heart AssociationOTHER
324 Previous Clinical Trials
4,933,742 Total Patients Enrolled
Dallin Tavoian, PhDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medications that could affect the study results, as per my doctor.I have had a perforated eardrum in the past.I have a history of glaucoma or retinopathy.You exercise aerobically more than four times a week.I have been diagnosed with asthma.I have been on the same dose of medication for at least three months.You currently smoke or use vaping devices or other tobacco products.I do not own a smartphone or am unwilling to download the required app.Your diastolic blood pressure is higher than 100 or lower than 60 mmHg.I experience periods of breathing that starts and stops while I sleep.You have a body mass index (BMI) of 40 or higher.I have had a collapsed lung in the past.I have a medical condition that is not currently under control.I have not had a heart attack or stroke in the last year.My medical history shows no unstable illnesses.My weight has been stable for the last 3 months and I can keep it stable during the study.Your top blood pressure number is between 120 and 169.I am 50 years old or older.Your blood pressure is too low (less than 120) or too high (more than 170).
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: IMST 1 day/week
- Group 3: IMST 3 days/week
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.
Is there still room available in this trial for participants?
"According to the records kept on clinicaltrials.gov, this research has stopped recruiting patients for now - which was first posted on May 1st 2023 and edited most recently on February 24th 2023. Nevertheless, there are 835 other studies that are actively seeking volunteers at present."
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