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Exercise Program for Heart Failure

Q: What is the uppermost limit of participants for this research endeavor?

<p>Yes, an examination of the clinicaltrials.gov page illustrates that this medical study is currently recruiting patients. It was originally published on December 1st 2022 and has been recently revised November 1st 2022. This endeavour needs to enrol 92 individuals from one locale across America.</p>

Q: Is participation in this experiment available to the public at present?

<p>Affirmative. According to clinicaltrials.gov, this medical study is actively recruiting patients, having been first published on December 1st 2022 and most recently edited November 1st 2022. 92 participants must be found from one site for the trial to proceed.</p>

N/A

Recruiting

Led By Jason Allen, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.

Subjects must be diagnosed with HFrEF as per established echocardiographic criteria (New York Heart Association Class II-III) with an ejection fraction <40%.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 40- weeks

Awards & highlights

Study Summary

This trial is testing if PRIME, an aerobic & resistance exercise program, is better than traditional exercise for people with heart failure. Participants will be randomly assigned one.

Who is the study for?

This trial is for individuals over 65 with heart failure and reduced ejection fraction (HFrEF), specifically those who can communicate well, have cardiologist approval, and a hemoglobin level of at least 10.0 g/dL. It's not for people with uncontrolled diabetes, recent heart attacks or embolism, severe valve disease needing surgery, new atrial fibrillation, worsening symptoms in the past few days, significant ischemia during low exercise levels, or certain other acute conditions.Check my eligibility

What is being tested?

The study compares a novel exercise program called PRIME against the traditional COMBO exercise regimen to see which one leads to better health outcomes for older patients with HFrEF. Participants will be randomly assigned to either the investigational PRIME program or the standard COMBO training.See study design

What are the potential side effects?

While specific side effects are not listed for these interventions since they involve physical exercise programs rather than drugs; general risks may include muscle soreness, fatigue after exercising and potential exacerbation of existing cardiac conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and communicate about the study, and I can legally consent.

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My heart's pumping ability is weak, and I have moderate heart failure symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40- weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~40- weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40- weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

VO2peak

Secondary outcome measures

Muscular fitness

Physical Function

Trial Design

2Treatment groups

Experimental Treatment

Group I: PRIME + COMBOExperimental Treatment2 Interventions

PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.

Group II: COMBO onlyExperimental Treatment1 Intervention

4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,833 Total Patients Enrolled

42 Trials studying Heart Failure

213,223 Patients Enrolled for Heart Failure

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,784 Total Patients Enrolled

35 Trials studying Heart Failure

7,794 Patients Enrolled for Heart Failure

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,244,981 Total Patients Enrolled

11 Trials studying Heart Failure

1,460 Patients Enrolled for Heart Failure

Media Library

PRIME + COMBO Clinical Trial Eligibility Overview. Trial Name: NCT05609097 — N/A

Heart Failure Research Study Groups: PRIME + COMBO, COMBO only

Heart Failure Clinical Trial 2023: PRIME + COMBO Highlights & Side Effects. Trial Name: NCT05609097 — N/A

PRIME + COMBO 2023 Treatment Timeline for Medical Study. Trial Name: NCT05609097 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost limit of participants for this research endeavor?

"Yes, an examination of the clinicaltrials.gov page illustrates that this medical study is currently recruiting patients. It was originally published on December 1st 2022 and has been recently revised November 1st 2022. This endeavour needs to enrol 92 individuals from one locale across America."

Answered by AI

Is participation in this experiment available to the public at present?

"Affirmative. According to clinicaltrials.gov, this medical study is actively recruiting patients, having been first published on December 1st 2022 and most recently edited November 1st 2022. 92 participants must be found from one site for the trial to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction

Jason Allen 2023. "PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05609097.