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

Not Applicable

Active, not recruiting

• Conditions: Exercise; Quality of Life; Cardiac Rehabilitation
• Interventions: Other: Standard of Care; Behavioral: KardioPAC Mobile Application

• Registration Number: NCT05643976
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Study Start: 2023-01-18
• Primary Completion: 2024-06-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-of-care cardiac rehabilitation (SOC CR)	Standard of Care	-
Cardiac Rehabilitation + KardioPAC (CR+KardioPAC)	KardioPAC Mobile Application	-
Cardiac Rehabilitation + KardioPAC (CR+KardioPAC)	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy.	~4 Months	Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change the activity level of participants.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life as measured by the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS®-29)	~4 Months	Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change health-related quality of life at pre- and post-CR.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States