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Behavioral Intervention

Physical Rehabilitation for Heart Failure (REHAB-HFpEF Trial)

N/A
Recruiting
Led By Dalane W Kitzman, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >=60 years old
At least 2 of the following signs of HF: a. Pulmonary congestion or edema on physical exam (rales or crackles) or by chest X-ray; b. Elevated jugular venous pressure or central venous pressure >=10 mm Hg; c. peripheral edema; d. wedge or left ventricular end diastolic pressure >=15 mmHg; e. rapid weight gain (>=5 lbs.); f. Increased b-type natriuretic peptide (BNP) (>=100 pg/ml) or N-terminal prohormone BNP (>=220pg/ml)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights

REHAB-HFpEF Trial Summary

This trial will test whether a new physical rehabilitation program can help improve heart function and reduce disability in older adults with heart failure and preserved ejection fraction.

Who is the study for?
This trial is for older individuals (60+) with heart failure where the heart still pumps well but symptoms like shortness of breath or fatigue have worsened. They must be hospitalized for these issues, able to walk, and not on regular intense exercise programs. Exclusions include recent heart attacks, severe valve disease, certain cardiomyopathies, terminal illnesses other than heart failure, severe kidney disease, dementia without support or very low cognitive scores.Check my eligibility
What is being tested?
The study tests a new physical rehabilitation program aimed at reducing hospital readmissions and mortality in older patients with acute decompensated heart failure who maintain good ejection fraction. It also looks at preventing major mobility disabilities over a six-month period after hospitalization.See study design
What are the potential side effects?
While specific side effects are not listed for this type of non-drug intervention, potential risks may include typical exercise-related injuries or health events due to increased physical activity in a vulnerable population.

REHAB-HFpEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I show at least 2 signs of heart failure, such as swelling, rapid weight gain, or breathing issues.
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I was hospitalized for more than a day due to worsening heart failure or diagnosed with it during another hospital stay.
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I can walk 4 meters by myself or with help.
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My heart failure symptoms have gotten worse, including trouble breathing or fatigue.

REHAB-HFpEF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Combined All-cause Rehospitalization and Death
Secondary outcome measures
Prevalence of major mobility disability (MMD)
Other outcome measures
6-minute Walk Distance (6MWD)
All-cause death
All-cause rehospitalization
+3 more

REHAB-HFpEF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Rehabilitation InterventionExperimental Treatment1 Intervention
The Rehabilitation Intervention is a novel, progressive, multi-domain rehabilitation and exercise training intervention. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. The intervention will begin as soon as possible after randomization during the hospitalization and will continue 3 times per week in an outpatient setting for 12 weeks.
Group II: Attention ControlActive Control1 Intervention
Attention control participants are contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rehabilitation Intervention
2021
N/A
~60

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,003,387 Total Patients Enrolled
8 Trials studying Heart Failure
2,148 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,025 Total Patients Enrolled
42 Trials studying Heart Failure
212,435 Patients Enrolled for Heart Failure
Dalane W Kitzman, MDPrincipal InvestigatorWake Forest University Health Sciences
7 Previous Clinical Trials
559 Total Patients Enrolled
7 Trials studying Heart Failure
559 Patients Enrolled for Heart Failure

Media Library

Rehabilitation Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05525663 — N/A
Heart Failure Research Study Groups: Attention Control, Rehabilitation Intervention
Heart Failure Clinical Trial 2023: Rehabilitation Intervention Highlights & Side Effects. Trial Name: NCT05525663 — N/A
Rehabilitation Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525663 — N/A

Frequently Asked Questions

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

Does this research program accept new participants?

"Clinicaltrials.gov indicates that the recruitment period for this medical trial has ended on August 30th, 2022 - it was first posted in January 1st of 2023. However, there are 702 other clinical studies still accepting participants at this time."

Answered by AI

Who else is applying?

What site did they apply to?
Atrium Health Wake Forest Baptist
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction
2023. "Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05525663.
~587 spots leftby Nov 2027
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