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Inspiratory Muscle Strength Training in Adults With Obesity

Primary Purpose

Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-resistance inspiratory muscle strength training
Very-low-resistance inspiratory muscle strength training
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Body mass index 30 - 40 kg/m2

Exclusion Criteria:

  • Not weight stable (<5% change in body mass over the past six months)
  • Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)
  • Current, or history of uncontrolled, Stage 2 hypertension (blood pressure >140 / 90 mmHg; anti-hypertensive medications are permitted)
  • Diagnosed obstructive sleep apnea
  • Previous bariatric surgery
  • Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)
  • Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)
  • Pregnant (self-reported and confirmed via urine pregnancy test), lactating (self-reported), or post-menopausal (self-reported) females
  • Prisoners

  • Per the POWERbreathe® company:

    • Patients who have undergone recent abdominal surgery and those with abdominal hernia.
    • Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnea.
    • If a patient is suffering from a ruptured eardrum or any other condition of the ear.
    • Patients with marked elevated left ventricular end-diastolic volume and pressure.
    • Patients with worsening heart failure signs and symptoms after training.
    • If an individual is suffering from a cold, sinusitis or respiratory tract infection, it is advised that they do not use the POWERbreathe device.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    High-resistance inspiratory muscle strength training

    Very-low resistance inspiratory muscle strength training

    Arm Description

    Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.

    Participants will perform very-low-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.

    Outcomes

    Primary Outcome Measures

    Change in laboratory-measured blood pressure
    Systolic and diastolic blood pressure measured in the laboratory

    Secondary Outcome Measures

    Change in ambulatory blood pressure
    Systolic and diastolic blood pressure measured at home using an automated monitor
    Change in inspiratory muscle strength
    Peak inspiratory pressure measured in the laboratory
    Change in blood pressure reactivity during aerobic exercise
    Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test
    Blood pressure during respiratory muscle testing
    Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)

    Full Information

    First Posted
    July 13, 2022
    Last Updated
    September 21, 2023
    Sponsor
    Florida State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05459636
    Brief Title
    Inspiratory Muscle Strength Training in Adults With Obesity
    Official Title
    Time-Efficient Inspiratory Muscle Strength Training as a New Approach to Lower Blood Pressure, Improve Respiratory Function, and Reduce Exertional Dyspnea in Adults With Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2027 (Anticipated)
    Study Completion Date
    June 30, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Florida State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.
    Detailed Description
    Obesity affects four-in-ten American adults and is associated with hypertension and greater all-cause mortality. Irrespective of weight loss, aerobic exercise reduces arterial blood pressure (BP) and improves cardiometabolic health. However, nearly half of adults with obesity do not perform aerobic exercise because of low leisure time availability and exertional dyspnea secondary to high chest wall mass-related inspiratory muscle dysfunction. In other clinical populations, emerging data demonstrates time-efficient high-resistance inspiratory muscle strength training (IMST) reduces BP and improves respiratory muscle function. Therefore, the investigators will determine whether eight weeks of daily high-resistance IMST reduces BP, improves respiratory muscle function, and concomitantly reduces exertional dyspnea in a randomized, double-blinded, sham-controlled (i.e., very low-resistance IMST) clinical trial among adults with obesity

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High-resistance inspiratory muscle strength training
    Arm Type
    Active Comparator
    Arm Description
    Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.
    Arm Title
    Very-low resistance inspiratory muscle strength training
    Arm Type
    Sham Comparator
    Arm Description
    Participants will perform very-low-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.
    Intervention Type
    Device
    Intervention Name(s)
    High-resistance inspiratory muscle strength training
    Intervention Description
    Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.
    Intervention Type
    Device
    Intervention Name(s)
    Very-low-resistance inspiratory muscle strength training
    Intervention Description
    Participants will perform very-low-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.
    Primary Outcome Measure Information:
    Title
    Change in laboratory-measured blood pressure
    Description
    Systolic and diastolic blood pressure measured in the laboratory
    Time Frame
    Up to 16 weeks
    Secondary Outcome Measure Information:
    Title
    Change in ambulatory blood pressure
    Description
    Systolic and diastolic blood pressure measured at home using an automated monitor
    Time Frame
    Up to 16 weeks
    Title
    Change in inspiratory muscle strength
    Description
    Peak inspiratory pressure measured in the laboratory
    Time Frame
    Up to 16 weeks
    Title
    Change in blood pressure reactivity during aerobic exercise
    Description
    Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test
    Time Frame
    Up to 16 weeks
    Title
    Blood pressure during respiratory muscle testing
    Description
    Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)
    Time Frame
    Up to 16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Body mass index 30 - 40 kg/m2 Exclusion Criteria: Not weight stable (<5% change in body mass over the past six months) Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus) Current, or history of uncontrolled, Stage 2 hypertension (blood pressure >140 / 90 mmHg; anti-hypertensive medications are permitted) Diagnosed obstructive sleep apnea Previous bariatric surgery Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s) Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping) Pregnant (self-reported and confirmed via urine pregnancy test), lactating (self-reported), or post-menopausal (self-reported) females Prisoners Per the POWERbreathe® company: Patients who have undergone recent abdominal surgery and those with abdominal hernia. Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnea. If a patient is suffering from a ruptured eardrum or any other condition of the ear. Patients with marked elevated left ventricular end-diastolic volume and pressure. Patients with worsening heart failure signs and symptoms after training. If an individual is suffering from a cold, sinusitis or respiratory tract infection, it is advised that they do not use the POWERbreathe device.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joseph C Watso, PhD
    Phone
    850-644-5260
    Email
    jwatso@fsu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
    IPD Sharing Time Frame
    One year after completion of trial, indefinitely
    IPD Sharing Access Criteria
    A formal plan identifying the intended use of the data and proper completion of appropriate data and/or material transfer agreement approvals with the study PI and their institution.

    Learn more about this trial

    Inspiratory Muscle Strength Training in Adults With Obesity

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