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Behavioural Intervention

App-Guided Breathing Exercises for High Blood Pressure

Phase 1

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 18+ years

Be older than 18 years old

Must not have

Age <18 years

Report of blood donation within 8 weeks prior to enrolling in the study or unwillingness to abstain from donating blood for 8 weeks after completing the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the effectiveness of using a smartphone app versus going to a clinic for a specific type of breathing exercise called inspiratory muscle strength training (IMST). The goal of the trial is to

Who is the study for?

This trial is for adults over 18 with high blood pressure. It's designed to see if a smartphone app can help them strengthen their breathing muscles and lower their blood pressure by guiding them through exercises they do at home.

What is being tested?

The study compares two ways of doing inspiratory muscle strength training (IMST): one uses a smartphone app to guide the training, while the other is done in a clinic. Participants will do these breathing exercises daily for six weeks.

What are the potential side effects?

Since this trial involves non-invasive breathing exercises, side effects may be minimal but could include temporary shortness of breath or fatigue immediately after the exercise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I haven't donated blood in the last 8 weeks and won't donate for 8 weeks after the study.

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I currently have a ruptured eardrum or another ear condition.

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I have had abdominal surgery in the last 3 months or have a current abdominal hernia.

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I have had or currently have inflammation in the rib cartilage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in casual systolic blood pressure

Change from baseline in home systolic blood pressure

Secondary study objectives

Change from baseline in endothelial function

Change from baseline in maximum inspiratory pressure

Difference in adherence to IMST

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: App-Based Inspiratory Muscle Strength TrainingExperimental Treatment1 Intervention

Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.

Group II: Clinic-Based Inspiratory Muscle Strength TrainingActive Control1 Intervention

Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.

0 / 6Eligibility criteria met