Clinical trial NCT05643976: Investigating KardioPAC Mobile App to Improve Physical Fitness Among Cardiac Rehabilitation Patients
Official title: Assessing the Ability of KardioPAC, a Digital Tool, to Facilitate Lifestyle Change in Participants Enrolled in a Cardiac Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Exercise
Quality of Life
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: KURA Care
First posted: 2022-12-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Able to give informed consent in English
3. Able to perform study assessments as described
4. Resting BP\<180/110 mmHg
5. Able to perform light to moderate exercise
6. Have not had a fall during the previous 6 months resulting in an injury
7. Clinical staff's permission to participate, including their assessment that participant is a good candidate for this research study
8. Ability to complete written or app-based surveys
9. Owns an Apple or Android mobile telephone capable of downloading and running the app

Exclusion Criteria:

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

Primary outcomes:
measure: Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy.
timeFrame: ~4 Months
Secondary outcomes:
measure: Health-related quality of life as measured by the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS®-29)
timeFrame: ~4 Months
Other outcomes:
measure: Resting Blood Pressure
timeFrame: ~4 Months
measure: Body Composition
timeFrame: ~4 Months
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References: