Clinical trial NCT02717806: Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
Official title: Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Dublin City University
First posted: 2016-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in total volume of weekly active energy expenditure
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae Hospital
Study officials:
References:
citation: Claes J, Cornelissen V, McDermott C, Moyna N, Pattyn N, Cornelis N, Gallagher A, McCormack C, Newton H, Gillain A, Budts W, Goetschalckx K, Woods C, Moran K, Buys R. Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial. J Med Internet Res. 2020 Feb 4;22(2):e14221. doi: 10.2196/14221.
citation: Claes J, Buys R, Woods C, Briggs A, Geue C, Aitken M, Moyna N, Moran K, McCaffrey N, Chouvarda I, Walsh D, Budts W, Filos D, Triantafyllidis A, Maglaveras N, Cornelissen VA. PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform. BMJ Open. 2017 Jun 30;7(6):e016781. doi: 10.1136/bmjopen-2017-016781.