HealthyNCT04984473
A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
A study testing Inspiratory muscle training in people with Healthy and Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Heart Failure
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18 years and older.
- English speaking.
- Has a qualifying heart failure indication for center-based cardiac rehabilitation.
- Adult 18 years and older.
- English speaking.
- Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex.
Who cannot join
- HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program.
- Participants unable/unwilling to provide informed consent.
- Uremia, history of allergy to iodides. Impaired renal function.
- Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months).
- Diagnosis of liver disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joshua Smith contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Joshua R. Smith, PhD
About this study
Official title: Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.
- Conditions
- Healthy, Heart Failure
- Being tested
- Inspiratory muscle training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| Sham arm | Sham comparator | Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks. Receives: Device: Inspiratory muscle training |
| Non-sham arm | Active comparator | Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks. Receives: Device: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure response
Mean arterial pressure
Measured: baseline and 12 week follow up
Change in blood flow response
respiratory muscle blood flow
Measured: baseline and 12 week follow up
Change in limb vascular resistance response
Limb vascular resistance
Measured: baseline and 12 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Jun 2021
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua R. Smith, Mayo Clinic
- Investigators
- Joshua Smith, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984473
- Sponsor's protocol ID
- 20-009490
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
- ClinicalTrials.gov ID
- NCT04984473
- Acronym / sponsor ID
- 20-009490
- Conditions
- Healthy, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Jul 2021 (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 understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham arm | Sham comparator | Device: Inspiratory muscle trainingPerform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks. |
| Non-sham arm | Active comparator | Device: Inspiratory muscle trainingPerform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult 18 years and older.
- English speaking.
- Has a qualifying heart failure indication for center-based cardiac rehabilitation.
- Adult 18 years and older.
- English speaking.
Key exclusion criteria (5 listed)
- HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program.
- Participants unable/unwilling to provide informed consent.
- Uremia, history of allergy to iodides. Impaired renal function.
- Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months).
- Diagnosis of liver disease.
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 |
|---|---|---|
| Inspiratory muscle trainingInspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure | Device | Non-sham arm, Sham arm |
Primary outcome
Blood pressure response
Time frame: baseline and 12 week follow up
Mean arterial pressure
Change in blood flow response
Time frame: baseline and 12 week follow up
respiratory muscle blood flow
Change in limb vascular resistance response
Time frame: baseline and 12 week follow up
Limb vascular resistance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Joshua Smith contact
Joshua Smith, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Healthy and Heart Failure, run by Mayo Clinic 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Bruhn, MA (507-266-2690, bruhn.eric@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure response (time frame: baseline and 12 week follow up). The study lists 3 primary outcomes in all. 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 17 Jul 2026.