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Mobile Health Cardiac Rehabilitation for Heart Failure

N/A
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults age> 18 years
Clinically stable and no hospitalization in last 4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 6 months
Awards & highlights

Study Summary

This trial is testing whether a patient specific, progressive home-based cardiac rehabilitation program delivered through an m-Health program can help improve functional status, exercise capacity, and quality of life in patients with heart failure with preserved ejection fraction.

Who is the study for?
This trial is for adults over 18 with heart failure where the heart's pumping function is preserved (HFpEF), specifically those who have a left ventricular ejection fraction greater than 50%. Participants should be on a stable diuretic regimen, not hospitalized in the last month, and have reduced exercise capacity. Those with recent falls, cancer, severe lung disease or very poor kidney function cannot join.Check my eligibility
What is being tested?
The study tests a home-based cardiac rehabilitation program using m-Health technology to improve physical function, exercise capacity, and quality of life in patients with HFpEF. It aims to see if this approach can be an effective alternative to supervised exercise programs.See study design
What are the potential side effects?
While specific side effects are not listed for this type of intervention since it involves exercise and education through m-Health tech rather than drugs or invasive procedures, potential risks may include injury from exercising without direct supervision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I haven't been hospitalized in the last month and my condition is stable.
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My water pill dosage has been the same for a while.
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My heart pumps well, with an ejection fraction over 50%.
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My physical function test score is low or my oxygen use during exercise is below 60% of what's expected for my age and gender.
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My heart pumps well, with an ejection fraction over 50%.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline Standard physical performance battery score at 3 and 6 months
Secondary outcome measures
6-minute walk distance
Peak VO2
Quality of Life using Kansas City Cardiomyopathy Questionnaire (KCCQ) score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: m-health cardiac rehabilitation intervention armExperimental Treatment1 Intervention
Participants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program
Group II: Usual care armActive Control1 Intervention
Participants in the usual control group will receive standard of care per their providers' discretion.

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,695 Total Patients Enrolled
23 Trials studying Heart Failure
13,259 Patients Enrolled for Heart Failure

Media Library

m-health cardiac rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05002075 — N/A
Heart Failure Research Study Groups: Usual care arm, m-health cardiac rehabilitation intervention arm
Heart Failure Clinical Trial 2023: m-health cardiac rehabilitation Highlights & Side Effects. Trial Name: NCT05002075 — N/A
m-health cardiac rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05002075 — N/A

Frequently Asked Questions

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

How many individuals have been chosen to participate in this research?

"Absolutely. Clinicaltrials.gov has the most recent information on this trial which was first posted on November 20th 2021 and is still actively recruiting participants. Currently, only one medical centre needs to enrol a total of twenty patients for the study."

Answered by AI

Is this experiment still recruiting participants?

"Affirmative. The information from clinicaltrials.gov states that this research is currently enrolling candidates. This study was initially advertised on November 20th 2021 and has since been updated to reflect current findings as of November 30th 2022. It seeks to include a total of 20 patients across one location."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
~0 spots leftby May 2024