---
title: A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
nct_id: NCT04984473
overall_status: RECRUITING
phase: NA
sponsor: Mayo Clinic
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04984473.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04984473"
ct_last_update_post_date: 2025-07-16
last_seen_at: "2026-05-12T06:19:15.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

**Official Title:** Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure

**NCT ID:** [NCT04984473](https://clinicaltrials.gov/study/NCT04984473)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 42
- **Lead Sponsor:** Mayo Clinic
- **Conditions:** Healthy, Heart Failure
- **Start Date:** 2021-06-01
- **Completion Date:** 2026-06
- **CT.gov Last Update:** 2025-07-16

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Sham arm** (SHAM_COMPARATOR) — Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.
- **Non-sham arm** (ACTIVE_COMPARATOR) — Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.

## Interventions

- **Inspiratory muscle training** (DEVICE) — Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure

## Primary Outcomes

- **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

## Locations (1)

- Mayo Clinic in Rochester, Rochester, Minnesota, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mayo clinic in rochester|rochester|minnesota|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04984473.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04984473*  
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