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RecruitingNCT04984473Updated Jul 17, 2026

A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

An interventional study of Inspiratory muscle training in Healthy and Heart Failure, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 42 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria - Heart Failure Group:

  • Adult 18 years and older.
  • English speaking.
  • Has a qualifying heart failure indication for center-based cardiac rehabilitation.

Inclusion Criteria - Healthy Control Group:

  • Adult 18 years and older.
  • English speaking.
  • Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex.

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (estimated)

Study arms

  • Sham comparator
    Sham arm

    Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.

    Device: Inspiratory muscle training

  • Active comparator
    Non-sham arm

    Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.

    Device: Inspiratory muscle training

Interventions

  • DeviceInspiratory muscle training

    Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure

06

What researchers measure

Primary outcomes

  1. Blood pressure response

    Mean arterial pressure

    Time frame: baseline and 12 week follow up

  2. Change in blood flow response

    respiratory muscle blood flow

    Time frame: baseline and 12 week follow up

  3. Change in limb vascular resistance response

    Limb vascular resistance

    Time frame: baseline and 12 week follow up

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • Joshua R. Smith, PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04984473
Lead sponsor
Mayo Clinic
Responsible party
Joshua R. Smith (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jul 30, 2021
Start date
Jun 1, 2021
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jul 17, 2026

Study contacts

Eric Bruhn, MA
Contact
bruhn.eric@mayo.edu
507-266-2690
Joshua Smith
Contact
smith.joshua1@mayo.edu
Joshua Smith, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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