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Recruiting

NCT Number: NCT04984473

A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

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.

Recruiting

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Key information

Conditions

Healthy Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Joshua R. Smith, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory muscle training

Device

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

Primary outcomes

  1. Blood pressure response

    Time frame: baseline and 12 week follow up

    Mean arterial pressure

  2. Change in blood flow response

    Time frame: baseline and 12 week follow up

    respiratory muscle blood flow

  3. Change in limb vascular resistance response

    Time frame: baseline and 12 week follow up

    Limb vascular resistance

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Bruhn, MA

CONTACT

[email protected]

507-266-2690

Joshua Smith

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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