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Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure

NCT06576297 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-04

No results posted yet for this study

Summary

In a randomized controlled trial, to study the utility of inspiratory muscle training (IMT) to improve functional outcomes in adults aged ≥70 years with heart failure (HF) who have been referred to palliative care for end-stage HF management.

* The study team hypothesize that older HF patients will be able to use IMT safely, reliably, and effectively in a 12-week home-based training regimen.
* The study team hypothesize that physical function (sit to stand, gait speed, grip strength), respiratory/pulmonary function, self-efficacy, fatigue and quality of life will increase among older HF patients randomized IMT versus those randomized to usual care.

Conditions

Interventions

OTHER

Inspiratory Muscle Training (IMT)

IMT using a PrO2™ inspiratory training device will incorporate the Test of Incremental Respiratory Endurance (TIRE)9 technology to achieve an optimized exercise training regimen.

OTHER

Standard of Care

Standard of Care Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.

Sponsors & Collaborators

  • The Pittsburgh Foundation

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Daniel E. Forman, M.D · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-02-28
Completion
2026-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576297 on ClinicalTrials.gov