eHealth for Promoting Physical Activity

November 30, 2023 updated by: University of Witten/Herdecke

eHealth for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance: the RehaPlus+ Concept

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 maintenance.This study aims to evaluate the effectiveness of the eHealth program "RehaPlus+" in motivating CAD patients for increased physical activity (PA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 programs.The 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 Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Ennepetal, NRW, Germany, 58256
        • Clinic Königsfeld

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • documented coronary artery disease
  • referral to inpatient rehabilitation
  • signed informed consent

Exclusion Criteria:

  • language barriers
  • incapable of understanding study information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RehaPlus+
Customized motivational text messages twice weekly for six months
Behavioral: RehaPlus+
24-week eHealth intervention
No Intervention: Usual care
Standard care (Six-month German outpatient program "IRENA")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: week 24
Physical activity will be assessed by the German "Physical Activity and Sports questionnaire" (BSA). The minimum value is 0, the maximum value is unlimited. A higher value indicates a better outcome.
week 24
Activity of Daily Living
Time Frame: week 24
Activity of Daily Living will be assessed by the German "Physical Activity and Sports questionnaire" (BSA). The minimum value is 0, the maximum value is unlimited. A higher value indicates a better outcome.
week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Work requirements and workload
Time Frame: Baseline and week 24
Work requirements and workload will be assessed using the "Workability Index (WAI)" questionnaire. The minimum value is 7, and the maximum value is 49, where a higher value indicates improved work ability.
Baseline and week 24
Change in Health-related quality of life
Time Frame: Baseline and week 24
Health-related quality of life will be assessed using the SF-36 questionnaire. The minimum value is 0, and the maximum value is 100, where a higher value signifies greater well-being.
Baseline and week 24
Change in Wellbeing
Time Frame: Baseline and week 24
Wellbeing will be assessed using the "WHO-5 Well-Being Index". The minimum value is 0, and the maximum value is 25, where a higher value signifies greater well-being.
Baseline and week 24
Change in Cardiac Self-Efficacy (CSE)
Time Frame: Baseline and week 24
Cardiac self-efficacy will be measured using the Cardiac Self-Efficacy questionnaire. The minimum value is 0, and the maximum value is 100, where a higher value signifies greater well-being.
Baseline and week 24
Physical activity (PA) at work
Time Frame: week 24
Physical activity at work will be assessed by the German "Physical Activity and Sports questionnaire" (BSA). The minimum value is 0, the maximum value is 9. A higher value indicates a better outcome.
week 24
Climbed floors
Time Frame: week 24
Climbed floors will be assessed by the German "Physical Activity and Sports questionnaire" (BSA). The minimum value is 0, the maximum value is unlimited. A higher value indicates a better outcome.
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Witten/Herdecke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

November 14, 2023

Study Completion (Actual)

November 14, 2023

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Estimated)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eHealth_RehaPlus_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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