KardioPAC App for Cardiac Rehabilitation

Overseen By Meredith A Pung, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Ventricular assist device, unmanaged angina, oxygen-dependent COPD, recent stroke, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called KardioPAC, designed to help individuals adhere to their cardiac rehab exercises. It targets those with heart-related conditions, such as heart attack or heart surgery, who are undergoing rehab. The app aims to improve exercise habits, enhance quality of life, and lower blood pressure compared to standard rehab alone. Participants should be able to perform light exercise, use a smartphone app, and be enrolled in a rehab program at UC San Diego Health. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cardiac rehabilitation for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the clinical staff to get a clear answer.

What prior data suggests that the KardioPAC Mobile Application is safe for cardiac rehabilitation?

Research has shown that digital tools like the KardioPAC mobile app can help individuals maintain their exercise routines during cardiac rehabilitation (CR). Studies have found these digital tools to be generally safe, posing no greater health risks than traditional CR methods.

The KardioPAC app complements regular CR programs by enhancing exercise habits. It features data syncing and automatic activity tracking to motivate users. So far, studies indicate that these digital tools are well-received, with few reports of negative effects.

Overall, using apps like KardioPAC alongside standard CR appears to be a safe option for most individuals. It is important to consult a healthcare provider to ensure it is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KardioPAC Mobile Application for cardiac rehabilitation because it offers a modern, tech-driven approach to heart health recovery. Unlike traditional cardiac rehabilitation, which often requires in-person visits and guided exercise sessions, KardioPAC enables patients to manage their rehabilitation from the comfort of their own homes using a mobile app. This remote accessibility can lead to increased adherence to rehab programs and potentially better outcomes, as patients can easily integrate it into their daily lives. Additionally, the app can provide real-time feedback and personalized guidance, making cardiac rehab more interactive and tailored to individual needs.

What evidence suggests that the KardioPAC app is effective for cardiac rehabilitation?

Research has shown that the KardioPAC mobile app, which participants in this trial may use alongside cardiac rehabilitation (CR), can significantly help people adhere to their exercise routines. Studies have found that digital health tools like KardioPAC improve exercise performance by easily connecting to Bluetooth and cellular devices, allowing patients to track their progress. One study found that a home-based CR program using a mobile app was as effective at improving exercise ability as traditional methods. Additionally, mobile apps that automatically sync data during exercise have been linked to better long-term health outcomes. These findings suggest that KardioPAC could help patients maintain their exercise habits more consistently, potentially leading to better heart health. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals referred to UC San Diego Health Cardiac Rehabilitation Center due to various heart conditions, who can complete surveys, give informed consent in English, perform light to moderate exercise, and own a smartphone. They should not have had a fall causing injury in the past 6 months or suffer from severe lung disease, recent stroke, unmanaged angina or be oxygen-dependent.

Inclusion Criteria

I am referred for intensive cardiac rehab at UC San Diego Health for a heart condition.

Resting BP<180/110 mmHg

Ability to complete written or app-based surveys

Exclusion Criteria

I cannot use a blood pressure monitor by myself.

I have not had a recent stroke or brain issues that would affect my trial participation.

Referred to CR following Ventricular Assist Device procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in cardiac rehabilitation with the KardioPAC digital tool to improve exercise adherence and health outcomes

16 weeks

Follow-up

Participants are monitored for changes in resting blood pressure, body composition, and health-related quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KardioPAC Mobile Application

Trial Overview The study tests if the KardioPAC mobile app plus standard cardiac rehab care improves physical activity adherence and health outcomes compared to just standard care. Participants will use the app designed to sustain regular exercise as part of their rehabilitation program.

How Is the Trial Designed?

Group I: Cardiac Rehabilitation + KardioPAC (CR+KardioPAC) Experimental Treatment 2 Interventions

Group II: Standard-of-care cardiac rehabilitation (SOC CR) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

KURA Care

Collaborator

Trials

1

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05643976?locStr=United+States&country=United+States&aggFilters=status%3A

Investigating KardioPAC Mobile App to Improve Physical ... This proposed study will examine the effectiveness of the Kura Care KardioPac digital application plus CR to significantly sustain exercise ...

2. ahajournals.org ahajournals.org/doi/10.1161/circ.150.suppl_1.4140111

Abstract 4140111: Impact of Digital Health Tools on ... This study aims to examine an app's effectiveness in enhancing exercise performance. The app (KardioPAC) connects to both Bluetooth and cellular ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433441/

Effectiveness of Home-Based Cardiac Rehabilitation ... A 6-week home-based CR program with exercise readjustment using a mobile app can potentially enhance exercise capacity as effectively as verbal supervision.

4. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05643976

UCSD Cardiac Rehabilitation Trial → KardioPAC Mobile App ... This proposed study will examine the effectiveness of the Kura Care KardioPac digital application plus CR to significantly sustain exercise ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation Mobile applications that have improved patient clinical outcomes often include features like data syncing and automatic recording during exercise, enabling ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001150

Digital Technologies in Cardiac Rehabilitation: A Science ... This American Heart Association science advisory was assembled to guide the development and implementation of digital cardiac rehabilitation interventions.