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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06576297
Acronym
RETRO
Enrollment
20
Registered
2024-08-28
Start date
2024-06-30
Completion date
2025-02-28
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Frailty, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, 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

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.

Interventions

OTHERInspiratory 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.

OTHERStandard 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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER
The Pittsburgh Foundation
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator, Outcomes assessor

Intervention model description

Parallel assignment

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Completion of 3-month Assessment3-monthThe number of participants who complete the 3-month assessment is used as a measure of intervention feasibility. Completion of this assessment indicates the feasibility of retaining participants in the study throughout the 3-month intervention period.

Secondary

MeasureTime frameDescription
Change in MIP (Maximum Inspiratory Pressure)Baseline to 3-monthsChange in maximum inspiratory pressure (MIP; cmH₂O). MIP is used as an indicator of inspiratory muscle strength
Change in Sit to Stand TimeBaseline to 3-monthsChange in Sit-to-Stand Time: Time needed to complete 5 Sit-to-Stands from a chair (in seconds).
Change in Gait SpeedBaseline to 3-month4 m Gait Speed: m/sec
Change in the Sullivan Self-Efficacy to Maintain Function ScaleBaseline to 3-monthChange in the Sullivan Self-Efficacy to Maintain Function Scale: 0-52; higher score is more favorable
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ): Quality of Life ScoreBaseline to 3-monthKansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life; score: 0-100; higher is more favorable than lower score.
Change in FatigueBaseline to 3-monthFatigue: PROMIS Item Bank v1.0 - Fatigue - short form 13a (FACIT-Fatigue): scale 0-52; lower indicates less fatigue.
Change in Grip Strength: kgBaseline to 3-monthsChange in Grip Strength (of dominant hand) in kilograms(kg)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDaniel E. Forman, M.D

University of Pittsburgh

Participant flow

Pre-assignment details

20 individuals enrolled in the study, however, 1 participant withdrew from the study prior to assignment.

Baseline characteristics

Characteristic
Age, Continuous74.32 Years
STANDARD_DEVIATION 5.63
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
17 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 10
other
Total, other adverse events
0 / 90 / 10
serious
Total, serious adverse events
0 / 90 / 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026