Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
Completed · Not applicable
Conditions studied: Aging, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Frailty, Physical Function, Quality of Life
In brief
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.
Key facts
- Study ID
- NCT06576297
- Run by
- University of Pittsburgh
- People needed
- 20
- Starts
- 2024-06-30
- Expected to finish
- 2025-02-28
- Last updated by the study team
- 2026-07-17
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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