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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Frailty; Aging; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction; Physical Function
• Intervention / Treatment: Other: Standard of Care; Other: Inspiratory Muscle Training (IMT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.	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.
Experimental: IMT Group: Inspiratory Muscle Training (IMT); IMT exercise sessions addition to standard of care.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of a 12-week home-based IMT program.	AE/SAE (IMT vs. controls): number Completion of the 3-month intervention (IMT vs. controls)	Baseline and weekly for 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to IMT training sessions	Number of IMT sessions competed over 12-week intervention	Baseline and weekly for 12 weeks
Improvement in MIP	Improvement in MIP (IMT vs. controls): cm H2O	Baseline, 12 weeks
Sit to stand	5-times Sit-to-Stand: seconds	Baseline, 12 weeks
Gait speed	4 m Gait Speed: m/sec	Baseline, 12 weeks
Grip strength	Grip Strength: pounds	Baseline, 12 weeks
Self-efficacy	Self-efficacy: Sullivan Self-Efficacy; 0-52; higher score is more favorable	Baseline, 12 weeks
Quality of Life	Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ): score 0-100; higher is more favorable than lower score.	Baseline, 12 weeks
Fatigue	Fatigue: PROMIS Item Bank v1.0 - Fatigue - short form 13a (FACIT-Fatigue): scale 0-52; lower indicates less fatigue.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: The Pittsburgh Foundation
• Investigators: Principal Investigator: Daniel E. Forman, M.D, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Frailty; Inspiratory Muscle Training; Physical function; Heart Failure with Preserved Ejection Fraction; Heart Failure with Reduced Ejection Fraction; 70 and older
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Frailty; Heart Failure
• Other Study ID Numbers: STUDY23010048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Hope to publish results of this pilot study.
• IPD Sharing Time Frame: Data will be available one year after study is closed.
• IPD Sharing Access Criteria: Per PI discretion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No