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AgingRETRONCT06576297

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

A study testing Inspiratory Muscle Training (IMT) in people with Aging and Heart Failure With Preserved Ejection Fraction, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Inspiratory Muscle Training (IMT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
30 Jun 2024to 28 Feb 2025
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.
Read the 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.

Being tested
Inspiratory Muscle Training (IMT), Standard of Care
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
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspiratory Muscle Training (IMT)Other

    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.

  • Standard of CareOther

    Standard of Care Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.

Study groups in NCT06576297
Study groupRoleWhat they receive
Standard of CareActive comparatorParticipants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
Receives: Other: Standard of Care
IMT Group: Inspiratory Muscle Training (IMT)ExperimentalIMT exercise sessions addition to standard of care.
Receives: Other: Inspiratory Muscle Training (IMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion of 3-month Assessment

    The 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.

    Measured: 3-month

Secondary outcomes (7)
  1. Change in MIP (Maximum Inspiratory Pressure)

    Change in maximum inspiratory pressure (MIP; cmH₂O). MIP is used as an indicator of inspiratory muscle strength

    Measured: Baseline to 3-months

  2. Change in Sit to Stand Time

    Change in Sit-to-Stand Time: Time needed to complete 5 Sit-to-Stands from a chair (in seconds).

    Measured: Baseline to 3-months

  3. Change in Gait Speed

    4 m Gait Speed: m/sec

    Measured: Baseline to 3-month

  4. Change in the Sullivan Self-Efficacy to Maintain Function Scale

    Change in the Sullivan Self-Efficacy to Maintain Function Scale: 0-52; higher score is more favorable

    Measured: Baseline to 3-month

  5. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ): Quality of Life Score

    Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life; score: 0-100; higher is more favorable than lower score.

    Measured: Baseline to 3-month

  6. Change in Fatigue

    Fatigue: PROMIS Item Bank v1.0 - Fatigue - short form 13a (FACIT-Fatigue): scale 0-52; lower indicates less fatigue.

    Measured: Baseline to 3-month

  7. Change in Grip Strength: kg

    Change in Grip Strength (of dominant hand) in kilograms(kg)

    Measured: Baseline to 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start30 Jun 2024
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06576297
Sponsor's protocol ID
STUDY23010048
Acronym
RETRO
Status last verified
Jul 2026
First submitted
22 Feb 2024
Last updated
17 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Hope to publish results of this pilot study.

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