What side effects are associated with this type of intervention?

The home-based exercise program using an m-Health platform for heart failure patients primarily focuses on improving functional status, exercise capacity, and quality of life through prescribed exercise and wellness education. Common side effects of exercise-based treatments for heart failure may include muscle soreness, fatigue, and, in rare cases, injury if exercises are not performed correctly. However, these programs are generally well-tolerated and can significantly enhance overall health outcomes when properly monitored by healthcare professionals.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that aim to improve functional status, exercise capacity, and quality of life. These include pharmacological agents like beta-blockers, ACE inhibitors, and ARBs, which help manage symptoms and improve heart function. Additionally, devices such as cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs) have been approved to enhance heart rhythm and prevent sudden cardiac death. While specific FDA approvals for home-based exercise programs using m-Health platforms are not detailed, these programs align with the broader trend of incorporating lifestyle modifications and technology to manage heart failure effectively.

What other types of research exist?

Promising, novel alternatives to a home-based exercise program using an m-Health platform for heart failure patients include: 1) Supervised exercise training programs, which have shown improvements in exercise capacity and quality of life but may face logistical barriers. 2) Telehealth-based cardiac rehabilitation, which can provide remote supervision and support similar to m-Health platforms. 3) Group behavior therapy programs, which can offer social support and structured exercise regimens. 4) Acceptance and Commitment Therapy (ACT) delivered face-to-face or by telephone, which has been effective in smoking cessation and could be adapted for lifestyle changes in heart failure patients.

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Mobile Health Cardiac Rehabilitation for Heart Failure

Q: What is the mechanism of action of this treatment?

Common treatments for heart failure include medications such as ACE inhibitors, beta-blockers, and diuretics, which work by reducing the workload on the heart, lowering blood pressure, and removing excess fluid. Additionally, lifestyle interventions like exercise programs are crucial. The home-based exercise program using an m-Health platform improves functional status, exercise capacity, and quality of life by providing personalized exercise regimens and wellness education. This approach is particularly beneficial for heart failure patients as it helps manage symptoms, enhances physical fitness, and reduces the risk of hospitalization.

N/A

Waitlist Available

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

Must not have

Estimated glomerular filtration rate < 45 mL/min/1.73 m2 as measured by the simplified MDRD formula

History of cancer or end stage lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help patients with a type of heart failure called HFpEF by using a home-based exercise program guided by a mobile app. The app provides personalized exercise plans and tracks progress to improve their heart health and quality of life.

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.

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.

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%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, with an eGFR below 45 mL/min.

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I have a history of cancer or severe lung disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months and 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline Standard physical performance battery score at 3 and 6 months

Secondary study objectives

6-minute walk distance

Peak VO2

Quality of Life using Kansas City Cardiomyopathy Questionnaire (KCCQ) score

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: 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include medications such as ACE inhibitors, beta-blockers, and diuretics, which work by reducing the workload on the heart, lowering blood pressure, and removing excess fluid. Additionally, lifestyle interventions like exercise programs are crucial. The home-based exercise program using an m-Health platform improves functional status, exercise capacity, and quality of life by providing personalized exercise regimens and wellness education. This approach is particularly beneficial for heart failure patients as it helps manage symptoms, enhances physical fitness, and reduces the risk of hospitalization.