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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.
Heart failure (both HF with reduced ejection fraction \[HFrEF\] and HF with preserved ejection fraction \[HFpEF\]) are on the rise in our aging population. Exercise intolerance is a leading detriment of the disease. While it is understood that exercise training is beneficial, strategies to achieve exercise training in this population are inherently limited, particularly as the issues that contribute to HF pathophysiology (i.e., advanced age, frailty, multimorbidity) also predispose to sedentariness, weakening, frailty, sarcopenia, fatigue, and cognitive impairment. Physical activity and particularly exercise training may be hard to initiate and sustain especially because it is encumbered by limitations. Home-based exercise training strategies are conceptually appealing in respect to practicality of access, but the associated issues of monitoring for effective and safe exercise, motivation, and tracking of training are all difficult to achieve in a home-based format. Furthermore, many older adults lack suitable space or resources for traditional home-based exercise training. IMT with the PrO2™ device responds to these challenges with a novel approach to achieve physiologically robust training effect (strength training of the diaphragm) in a way that mitigates breathlessness and augments multiple indices of function in a way that is practical and safe, even at home. The electronic dimensions of the device also enable embedded trackability and behavioral prompts. Overall, this is a novel approach to a common, familiar problem, and it responds directly to a well-known problem of dyspnea, sedentariness and related functional decline that undermines current standards of HF care. Existing models of exercise training for HF rely primarily on site-based regimens of aerobic and strength training modalities. Implementation barriers include unfeasible logistics for patients who often do not drive, particularly as many older patients struggle with frailty as well as limitations due to cognitive decline, sensory impairment, and/or socioeconomic challenges amidst the predictable complexities associated with advanced age. Fear and poor motivation compound these limitations, with limited options to motivate, supervise, and track progress for many candidates. This proposal promotes the concept of "Palliative Care Rehab" which is transformational in concept. It shifts the premise of cardiac rehabilitation from cardiorespiratory fitness to more rudimentary goals of activities of daily living and self-efficacy. Likewise, rather than focusing on traditional cardiovascular endpoints of exercise testing and high performance, this study is oriented to submaximal endpoints, fatigability, and qualitative metrics.
Age
70 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Start Date
June 30, 2024
Primary Completion Date
February 28, 2025
Completion Date
February 28, 2026
Last Updated
July 4, 2025
30
ESTIMATED participants
Inspiratory Muscle Training (IMT)
OTHER
Standard of Care
OTHER
Lead Sponsor
University of Pittsburgh
Collaborators
Data Source & Attribution
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