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.
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
- Conditions the study is for
- Aging, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction
- 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
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.
- Conditions
- Aging, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Frailty, Physical Function, Quality of Life
- 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 group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants 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) | Experimental | IMT 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.
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)
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
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
Change in Gait Speed
4 m Gait Speed: m/sec
Measured: Baseline to 3-month
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
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
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
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.
- First posted28 Aug 2024
- Study start30 Jun 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Pittsburgh Foundation
- Responsible party
- Principal investigator, Daniel Forman, MD, University of Pittsburgh
- Investigators
- Daniel E. Forman, M.D, Principal investigator, University of Pittsburgh
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Hope to publish results of this pilot study.