RECRUITING

Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure

Conditions

Blood Pressure Vascular Function Adherence, Treatment Inspiratory Muscle Strength Training Above-normal blood pressure Smartphone Application Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial aims to assess the efficacy of inspiratory muscle strength training (IMST) guided by a smartphone app vs. IMST delivered in a clinical research setting for lowering systolic blood pressure in adults 18 years and older with elevated blood pressure. Participants will perform IMST for 5 minutes a day, 6 days a week, for 6 weeks.

Official Title

Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure

Quick Facts

Study Start:2024-07-11

Study Completion:2025-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06229873

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18+ years * Ability to provide informed consent * Willing to accept random assignment to condition * Systolic blood pressure 120-160 mmHg * Owns an Apple or Android smartphone * Body mass index \<40 kg/m2 * Subject report of being weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable during the 6-week intervention period * Subjects taking antihypertensive medications will be included provided they meet the other inclusion criteria, including systolic blood pressure. Medication regimen (prescription and dosing) must be stable for at least 3 months prior to enrollment in the study and must remain stable during the 6-week intervention period. These medications will not be withheld prior to experimental protocols. * If woman of childbearing age: * Not pregnant (defined as self-report of pregnancy) * Willing to be abstinent or use approved contraception (i.e., hormonal contraception, intrauterine devices, barrier methods such as condoms with spermicide, and surgical sterilization) throughout the duration of the study	* Age \<18 years * Participant report of a chronic overt medical condition (e.g., unstable cardiovascular disease, recent myocardial infarction or stroke, cancer) that may make it unsafe to participate in the study under the discretion of the study Medical Director. * Inability to abstain from consumption of alcohol for 12 hours on experimental days. * 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 * Participant report of current ruptured eardrum or any other current condition of the ear * Participant report of recent abdominal surgery (past 3 months) or current abdominal hernia * Participant report of current asthma with very low symptom perception, frequent and severe exacerbations, or abnormally low perception of dyspnea * Participant report of past or current costochondritis (inflammation of the cartilage that joins the ribs to the breastbone)

Inclusion Criteria

Exclusion Criteria

* Age 18+ years
* Ability to provide informed consent
* Willing to accept random assignment to condition
* Systolic blood pressure 120-160 mmHg
* Owns an Apple or Android smartphone
* Body mass index \<40 kg/m2
* Subject report of being weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable during the 6-week intervention period
* Subjects taking antihypertensive medications will be included provided they meet the other inclusion criteria, including systolic blood pressure. Medication regimen (prescription and dosing) must be stable for at least 3 months prior to enrollment in the study and must remain stable during the 6-week intervention period. These medications will not be withheld prior to experimental protocols.
* If woman of childbearing age:
* Not pregnant (defined as self-report of pregnancy)
* Willing to be abstinent or use approved contraception (i.e., hormonal contraception, intrauterine devices, barrier methods such as condoms with spermicide, and surgical sterilization) throughout the duration of the study

* Age \<18 years
* Participant report of a chronic overt medical condition (e.g., unstable cardiovascular disease, recent myocardial infarction or stroke, cancer) that may make it unsafe to participate in the study under the discretion of the study Medical Director.
* Inability to abstain from consumption of alcohol for 12 hours on experimental days.
* 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
* Participant report of current ruptured eardrum or any other current condition of the ear
* Participant report of recent abdominal surgery (past 3 months) or current abdominal hernia
* Participant report of current asthma with very low symptom perception, frequent and severe exacerbations, or abnormally low perception of dyspnea
* Participant report of past or current costochondritis (inflammation of the cartilage that joins the ribs to the breastbone)

Contacts and Locations

Study Contact

Daniel H Craighead, PhD

CONTACT

303-492-3010

daniel.craighead@colorado.edu

Elizabeth Jones, BA

CONTACT

303-492-2485

imstapp@colorado.edu

Principal Investigator

Daniel H Craighead, PhD

PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Study Locations (Sites)

University of Colorado Boulder

Boulder, Colorado, 80309

United States

Collaborators and Investigators

Sponsor: University of Colorado, Boulder

Daniel H Craighead, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Boulder

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11

Study Completion Date2025-11-30

Study Record Updates

Study Start Date2024-07-11

Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

Inspiratory Muscle Strength Training
Above-normal blood pressure
Smartphone Application
Hypertension

Additional Relevant MeSH Terms

Blood Pressure
Vascular Function
Adherence, Treatment