Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness

The PATHway system is designed to help patients remain physically active and maintain a good cardiovascular health. It proposes a novel approach that aims to empower patients to self-manage their CVD, set within a collaborative care context with health professionals. This will be achieved via a patient-centric holistic approach that specifically addresses the above barriers. It involves an internet-enabled and sensor-based home exercise platform. It is represented by several modules with an exercise module as the core component which will provide individualized rehabilitation programs that use regular, socially inclusive exercise sessions as the basis upon which to provide a personalized, comprehensive lifestyle intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable patients to both better understand and deal with their own condition and to lead a healthier lifestyle in general.

The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle and health related physical fitness and cost-effectiveness of the PATHway intervention in patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven, Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Men and women with documented CVD
age 40-80 yrs
patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
patients must have completed the ambulatory CR program and received clinical approval from their treating physician to continue exercising outside the hospital program
internet access at home

Exclusion criteria

significant illness during the last 6 weeks
known severe ventricular arrhythmia with functional or prognostic significance
significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
cardiac disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
co-morbidity that may significantly influence one-year prognosis
functional or mental disability that may limit exercise
acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
GFR <25ml/min/1.73m2
hemoglobin < 10g/dl
severe chronic obstructive pulmonary disease (FEV1 < 50%)
NYHA class 4
participation in another clinical trial

Treatment and study plan

PATHway

Behavioral

Patients will use the PATHway platform for 6 months

Primary outcomes

Change in total volume of weekly active energy expenditure

Time frame: 3 and 6 months

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

Dublin City University

Registry information

Acronym: PATHway

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Mar 24, 2016
Registry last updated: Jan 16, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed