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Behavioural Intervention

Respiratory Training for Heart Failure (RETRO Trial)

N/A
Recruiting
Led By Daniel E. Forman, M.D
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >70 years
Be older than 65 years old
Must not have
Severe valvular heart disease
Psychiatric hospitalization within the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if breathing exercises can help improve the daily activities and overall well-being of older adults with heart failure who are receiving end-of-life care. The researchers believe that a 12-week

Who is the study for?
This trial is for adults aged 70 or older with heart failure who are receiving palliative care for end-stage management of their condition. Participants should be able to perform a home-based training regimen.
What is being tested?
The study is testing Inspiratory Muscle Training (IMT) compared to standard care, hypothesizing that IMT will improve physical and respiratory function, self-efficacy, fatigue levels, and overall quality of life over a 12-week period.
What are the potential side effects?
While specific side effects are not listed, IMT may cause discomfort or muscle soreness due to the respiratory exercises involved. Any other potential risks would likely be minimal as this intervention is non-invasive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart valve disease.
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I have not been hospitalized for psychiatric reasons in the last 3 months.
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I haven't had a major heart event or procedure in the last 6 weeks.
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I have severe lung problems, poor blood flow in my legs, or very low blood iron levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of a 12-week home-based IMT program.
Secondary study objectives
Adherence to IMT training sessions
Fatigue
Gait speed
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IMT Group: Inspiratory Muscle Training (IMT)Experimental Treatment1 Intervention
IMT exercise sessions addition to standard of care.
Group II: Standard of CareActive Control1 Intervention
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,593 Total Patients Enrolled
The Pittsburgh FoundationOTHER
6 Previous Clinical Trials
359 Total Patients Enrolled
Daniel E. Forman, M.DPrincipal InvestigatorUniversity of Pittsburgh
~20 spots leftby Oct 2025
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