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Simple breathing training may ease heart failure symptoms in seniors

NCT ID NCT06576297

Symptom relief Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether a 12-week home-based breathing exercise program (inspiratory muscle training) can improve physical function, fatigue, and quality of life in adults aged 70 and older with advanced heart failure who are receiving palliative care. Participants use a handheld device to strengthen their breathing muscles. The goal is to see if this safe, low-cost approach can help older patients maintain independence and feel better day-to-day.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inspiratory muscle training using a PrO2™ device
What this could lead to
If effective, this simple home-based breathing exercise could become a standard part of palliative care to help older heart failure patients stay stronger and feel better.
What could go wrong
This is a very small early feasibility study with only 20 participants, so results may not apply broadly. The training may be too demanding for some frail patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jun 2024

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with Advanced Heart Failure (HFrEF or HFpEF), with NYHA class II, III, or IV despite a minimum of * 6 weeks of treatment * Age \>70 years * Male and Female * Optimal therapy according to AHA/ACC and HFSA HF guidelines Exclusion Criteria: * Patients living in an institutional setting (e.g., skilled nursing home) during the intended period of this study. * Major cardiovascular event or procedure within the prior 6 weeks. * HF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction). If valve replacement has been performed, the participant may not be enrolled for 12 months after this procedure. * Dementia * Severe COPD (FEV1\<50%), PVD, and/or Anemia * End-stage malignancy * Severe valvular heart disease * Psychiatric hospitalization within the last 3 months * Chronic ETOH or drug dependency. We will exclude all of the following special populations: * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners

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Conditions

The condition(s) this trial relates to.

diastolic heart failure Frailty heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aging Frailty Heart failure with preserved ejection fraction Heart failure with reduced ejection fraction Physical function Quality of life

Contacts and locations

Locations

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

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