ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-30
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06576297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with Advanced Heart Failure (HFrEF or HFpEF), with NYHA class II, III, or IV despite a minimum of
  2. * 6 weeks of treatment
  3. * Age \>70 years
  4. * Male and Female
  5. * Optimal therapy according to AHA/ACC and HFSA HF guidelines
  1. * Patients living in an institutional setting (e.g., skilled nursing home) during the intended period of this study.
  2. * Major cardiovascular event or procedure within the prior 6 weeks.
  3. * 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.
  4. * Dementia
  5. * Severe COPD (FEV1\<50%), PVD, and/or Anemia
  6. * End-stage malignancy
  7. * Severe valvular heart disease
  8. * Psychiatric hospitalization within the last 3 months
  9. * Chronic ETOH or drug dependency.
  10. * Adults unable to consent
  11. * Individuals who are not yet adults (infants, children, teenagers)
  12. * Pregnant women
  13. * Prisoners

Contacts and Locations

Principal Investigator

Daniel E. Forman, M.D
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Daniel E. Forman, M.D, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-30
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-06-30
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • 70 and older
  • Inspiratory Muscle Training
  • Heart Failure with Preserved Ejection Fraction
  • Heart Failure with Reduced Ejection Fraction
  • Frailty
  • Physical function
  • Quality of life

Additional Relevant MeSH Terms

  • Aging
  • Heart Failure With Preserved Ejection Fraction
  • Heart Failure With Reduced Ejection Fraction
  • Frailty
  • Physical Function
  • Quality of Life