Inspiratory muscle training for older adults with heart failure in palliative care
Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
This study is testing if a special breathing exercise program can help older adults with heart failure feel stronger and improve their quality of life while they receive palliative care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06576297 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of inspiratory muscle training (IMT) in improving physical function and quality of life for adults aged 70 and older who have heart failure and are receiving palliative care. Participants will engage in a 12-week home-based training program using the PrO2™ device, which aims to strengthen the diaphragm and enhance respiratory function. The study will compare outcomes between those receiving IMT and those receiving standard care, focusing on metrics such as gait speed, grip strength, and overall self-efficacy. The goal is to provide a practical and safe exercise solution for older adults facing the challenges of heart failure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 70 and older with advanced heart failure who are not living in institutional settings.
Not a fit: Patients with severe COPD, dementia, or those who have experienced major cardiovascular events recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the physical function and quality of life for older adults with heart failure.
How similar studies have performed: While inspiratory muscle training has been explored in various contexts, this specific application in older adults with heart failure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Daniel E. Forman, M.D — University of Pittsburgh
- Study coordinator: Tara S Stakich
- Email: tss54@pitt.edu
- Phone: 412-864-2082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.