Clinical trial NCT06576297: Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
Official title: Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Heart Failure With Preserved Ejection Fraction
Heart Failure With Reduced Ejection Fraction
Frailty
Physical Function
Quality of Life
Keywords: 70 and older
Inspiratory Muscle Training
Heart Failure with Preserved Ejection Fraction
Heart Failure with Reduced Ejection Fraction
Frailty
Physical function
Quality of life
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Pittsburgh Foundation
First posted: 2024-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Safety of a 12-week home-based IMT program.
timeFrame: Baseline and weekly for 12 weeks
Secondary outcomes:
measure: Adherence to IMT training sessions
timeFrame: Baseline and weekly for 12 weeks
measure: Improvement in MIP
timeFrame: Baseline, 12 weeks
measure: Sit to stand
timeFrame: Baseline, 12 weeks
measure: Gait speed
timeFrame: Baseline, 12 weeks
measure: Grip strength
timeFrame: Baseline, 12 weeks
measure: Self-efficacy
timeFrame: Baseline, 12 weeks
measure: Quality of Life
timeFrame: Baseline, 12 weeks
measure: Fatigue
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Daniel E. Forman, M.D
role: PRINCIPAL_INVESTIGATOR
References: