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OpenTrials
Completed

NCT Number: NCT05643976

Investigating KardioPAC Mobile App to Improve Physical Fitness Among Cardiac Rehabilitation Patients

The purpose of this study is to sustain regular physical activity, improve health-related quality of life, improve resting blood pressure, improve anthropometrics, and improve adherence to prescribed cardiac rehabilitation sessions among individuals referred for cardiac rehabilitation (CR). Numerous studies show that CR improves clinical outcomes in cardiovascular disease (CVD). Exercise as a reliable adjunctive intervention, however, remains limited due to poor short- and long-term adherence. This proposed study will examine the effectiveness of the Kura Care KardioPac digital application plus CR to significantly sustain exercise adherence among CR patients, as compared to standard of care alone.

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Key information

Conditions

Cardiac Rehabilitation Behavior Exercise Motor Activity Quality of Life

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Referred to the University of California San Diego Health Cardiac Rehabilitation Center for 36-72 sessions of intensive cardiac rehabilitation for one of the following medical conditions: myocardial infarction, coronary artery bypass surgery, stable angina, heart valve repair or replacement, coronary angioplasty or stenting, congestive heart failure, heart transplant, or peripheral arterial disease
  • Able to give informed consent in English
  • Able to perform study assessments as described
  • Resting BP<180/110 mmHg
  • Able to perform light to moderate exercise
  • Have not had a fall during the previous 6 months resulting in an injury
  • Clinical staff's permission to participate, including their assessment that participant is a good candidate for this research study
  • Ability to complete written or app-based surveys
  • Owns an Apple or Android mobile telephone capable of downloading and running the app

Exclusion criteria

  • Referred to CR following Ventricular Assist Device procedure
  • Angina not adequately managed with nitrates
  • Oxygen-dependent Chronic Obstructive Pulmonary Disease
  • Recent stroke or significant cerebral neurologic impairment that would interfere with participation.
  • Unable to operate a BP device

Treatment and study plan

KardioPAC Mobile Application

Behavioral

Like those in the SOC CR arm, participants assigned to the CR+KardioPAC arm will receive standard of care and attend CR as prescribed by their physician. Additionally, they will receive access to the digital app, KardioPAC, & a BP device for home use that will record their BP readings in the app.

KardioPAC is a remote patient monitoring system that allows providers to monitor patients and send out daily reminders. It integrates with BP monitors and fitness watches to collect patient health information at home. The information is uploaded to the HIPAA-compliant server and presented on the website for providers to read. Its reminder system can be customized to meet diverse clinical needs.

Lastly, the Kura Care in-house Registered Nurse will provide 20-30 min of health coaching to intervention arm participants on a weekly or bi-weekly basis via the app. The coaching will include greetings, review of medication adherence, encouragement to exercise, and symptom management, if applicable.

Standard of care

Other

During the prescribed cardiac rehabilitation, the SOC CR intervention participants will receive standard of care by attending the 36-72 sessions of CR as prescribed by his/her physician and administered by the University of California San Diego Health Cardiac Rehabilitation Center.

Primary outcomes

  1. Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy.

    Time frame: ~4 Months

    Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change the activity level of participants.

Secondary outcomes

  1. Delta change in METs (Metabolic Equivalents of Task), a measure of the amount of oxygen consumed during activity compared to resting oxygen consumption.

    Time frame: ~4 Months

    Assess the ability of CR + KardioPAC as compared to standard-of-care CR to improve functional capacity (METs) at pre- and post-CR.

Other outcomes

  1. Resting Blood Pressure

    Time frame: ~4 Months

    Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change resting blood pressure at pre- and post-CR.

  2. Body Composition

    Time frame: ~4 Months

    Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change body composition at pre- and post-CR.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • KURA Care

Registry information

Official study title

Assessing the Ability of KardioPAC, a Digital Tool, to Facilitate Lifestyle Change in Participants Enrolled in a Cardiac Rehabilitation Program

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 9, 2022
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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