A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Sham arm

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

Group Type SHAM_COMPARATOR

Inspiratory muscle training

Intervention Type DEVICE

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

Non-sham arm

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

Group Type ACTIVE_COMPARATOR

Inspiratory muscle training

Intervention Type DEVICE

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

Interventions

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Inspiratory muscle training

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes