Viewing Study NCT06162793



Ignite Creation Date: 2024-05-06 @ 7:51 PM
Last Modification Date: 2024-10-26 @ 3:15 PM
Study NCT ID: NCT06162793
Status: COMPLETED
Last Update Posted: 2023-12-08
First Post: 2023-11-20

Brief Title: eHealth for Promoting Physical Activity
Sponsor: University of WittenHerdecke
Organization: University of WittenHerdecke

Study Overview

Official Title: eHealth for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance the RehaPlus Concept
Status: COMPLETED
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Coronary artery disease CAD is a chronic disease without a definitive cure Cardiac rehabilitation CR is a class IA recommendation for CAD patients that focuses on risk factor reduction and physical exercise It comprises three stages Phase I in the acute setting Phase II for reconditioning and Phase III as maintenance Despite the effectiveness of Phase II there is often a decline in cardiovascular risk profiles afterward due to lifestyle challenges and inadequate support

Traditional maintenance programs face limitations such as high costs and patient-related barriers With the increasing prevalence of mobile devices and digitalization eHealth can enhance rehabilitation effectiveness post-discharge Previous studies support the effectiveness of eHealth in CR maintenanceThis study aims to evaluate the effectiveness of the eHealth program RehaPlus in motivating CAD patients for increased physical activity PA
Detailed Description: Coronary artery disease CAD a chronic disease lacking a definitive cure can be mitigated through cardiac rehabilitation CR As a class IA recommendation for CAD patients CR employs evidence-based therapy to minimize the physiological and psychological impacts of CAD reduce morbidity and mortality rates and enhance physical performance CR involves three stages Phase I for acute intervention Phase II for reconditioning and Phase III for maintenance Despite the effectiveness of Phase II CR cardiovascular risk profiles often deteriorate thereafter attributed to the challenge of maintaining a healthy lifestyle and limited support of patients Traditional maintenance programs face barriers such as high costs and time constraints while the COVID-19 pandemic further disrupted on-site programsThe rise of eHealth solutions such as the RehaPlus concept driven by innovative technologies and the prevalence of mobile devices aligns with the trend of digitalization in healthcare This evolution presents opportunities to enhance patient health maintenance with eHealth applications amplifying rehabilitation effectiveness post-discharge Previous studies support the efficacy of eHealth in CR maintenance

This study aims to assess the effectiveness of the eHealth program RehaPlus in supporting CAD patients for increased physical activity PA The hypothesis is that RehaPlus will be as effective as the German standard center-based program IRENA in supporting regular PA Activity of Daily Living AoDL and improving psychological well-being cardiac self-efficacy CSE health-related well-being and work ability six months after Phase II CR discharge

The study will include patients with CAD allocated to either a 24-week eHealth group RehaPlus or a conventional outpatient program group IRENA using a quasi-experimental approach RehaPlus recipients will receive customized motivational text messages twice weekly for six months while the IRENA group will engage in a six-month outpatient program involving 24 sessions of 90-minute strength and endurance training The primary outcomes evaluated using the BSA questionnaire will focus on regular PA and weekly activities of daily living AoDL six months post-rehabilitation Secondary outcomes will examine physical activity during work and floors climbed weekly BSA psychological well-being WHO-5 cardiac self-efficacy CSE health-related well-being SF-36 and work ability WAI via questionnaire

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None