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

NCT06576297 | Completed Results

• 1 other identifier: STUDY23010048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

  3-month

Secondary Outcomes (7)

• Change in MIP (Maximum Inspiratory Pressure)

  Baseline to 3-months

• Change in Sit to Stand Time

  Baseline to 3-months

• Change in Gait Speed

  Baseline to 3-month

• Change in the Sullivan Self-Efficacy to Maintain Function Scale

  Baseline to 3-month

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

  Baseline to 3-month

Study Arms (2)

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.

Other: Standard of Care

IMT Group: Inspiratory Muscle Training (IMT)

EXPERIMENTAL

IMT exercise sessions addition to standard of care.

Other: Inspiratory Muscle Training (IMT)

Interventions

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.

IMT Group: Inspiratory Muscle Training (IMT)

Standard of Care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with Advanced Heart Failure (HFrEF or HFpEF), with NYHA class II, III, or IV despite a minimum of
• weeks of treatment
• Age \>70 years
• Male and Female
• Optimal therapy according to AHA/ACC and HFSA HF guidelines

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Pittsburgh Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Daniel E. Forman, M.D.
• Organization: University of Pittsburgh

Formand@pitt.edu

412-864-2082

Study Officials

• Daniel E. Forman, M.D

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator, Outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel assignment

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: August 28, 2024
• Study Start: June 30, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: July 17, 2026
• Results First Posted: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available one year after study is closed.
• Access Criteria: Per PI discretion

Locations

US (1)