ObesityNCT05459636
Inspiratory Muscle Strength Training in Adults With Obesity
A study testing High-resistance inspiratory muscle strength training and Very-low-resistance inspiratory muscle strength training in people with Obesity, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High-resistance inspiratory muscle strength training and Very-low-resistance inspiratory muscle strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 16 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 30 - 40 kg/m2
Who cannot join
- 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)
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
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
The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.
Read the 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
- Conditions
- Obesity
- Being tested
- High-resistance inspiratory muscle strength training, Very-low-resistance inspiratory muscle strength training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resistance inspiratory muscle strength trainingDevice
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.
Very-low-resistance inspiratory muscle strength trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High-resistance inspiratory muscle strength training | Active comparator | 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. Receives: Device: High-resistance inspiratory muscle strength training |
| Very-low resistance inspiratory muscle strength training | Sham comparator | 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. Receives: Device: Very-low-resistance inspiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in laboratory-measured blood pressure
Systolic and diastolic blood pressure measured in the laboratory
Measured: Up to 16 weeks
Secondary outcomes (4)
Change in ambulatory blood pressure
Systolic and diastolic blood pressure measured at home using an automated monitor
Measured: Up to 16 weeks
Change in inspiratory muscle strength
Peak inspiratory pressure measured in the laboratory
Measured: Up to 16 weeks
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
Measured: Up to 16 weeks
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)
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start7 Dec 2023
- Primary completion16 Sep 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joseph Watso, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459636
- Sponsor's protocol ID
- STUDY00003098
- Other IDs
- K01HL160772
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05459636
- Acronym / sponsor ID
- STUDY00003098
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-resistance inspiratory muscle strength training | Active comparator | Device: High-resistance inspiratory muscle strength trainingParticipants 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. |
| Very-low resistance inspiratory muscle strength training | Sham comparator | Device: Very-low-resistance inspiratory muscle strength trainingParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index 30 - 40 kg/m2
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-resistance inspiratory muscle strength trainingParticipants 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. | Device | High-resistance inspiratory muscle strength training |
| Very-low-resistance inspiratory muscle strength trainingParticipants 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. | Device | Very-low resistance inspiratory muscle strength training |
Primary outcome
Change in laboratory-measured blood pressure
Time frame: Up to 16 weeks
Systolic and diastolic blood pressure measured in the laboratory
4 secondary outcomes
Change in ambulatory blood pressure
Time frame: Up to 16 weeks
Change in inspiratory muscle strength
Time frame: Up to 16 weeks
Change in blood pressure reactivity during aerobic exercise
Time frame: Up to 16 weeks
Blood pressure during respiratory muscle testing
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-resistance inspiratory muscle strength training and Very-low-resistance inspiratory muscle strength training in people with Obesity, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in laboratory-measured blood pressure (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.