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

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ClinicalTrials.gov Identifier: NCT02717806
Recruitment Status : Recruiting
First Posted : March 24, 2016
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Cardiovascular Disease Behavioral: PATHway

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
Study Start Date : January 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PATHway

Patients allocated to the PATHway intervention will be given a 4 week run-in period as an outpatient to get acquainted with the system. During this run-in period, the PATHway system will also be installed in each participant's home. They will be provided with a training manual and a quick set up guide for getting started with PATHway in the home.

After this 4 week run-in period, the PATHway system will be set up for each individual patient including a patient specific exercise prescription. The patient will then exercise with the PATHway platform for 6 months.

Behavioral: PATHway
Patients will use the PATHway platform for 6 months
No Intervention: Usual care
Patients randomized to the control group will receive usual care.

Outcome Measures

Primary Outcome Measures :
  1. Change in total volume of weekly active energy expenditure [ Time Frame: 3 and 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717806

Contact: Roselien Buys, PhD 0032 16 344167 roselien.buys@kuleuven.be
Contact: Véronique Cornelissen, PhD 0032 16 329152 veronique.cornelissen@kuleuven.be

University Hospitals Leuven Recruiting
Leuven, Belgium
Contact: Roselien Buys, PhD       roselien.buys@kuleuven.be   
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Helen Newton, RN       CardiacRehab@beaumont.ie   
Mater Misericordiae Hospital Recruiting
Dublin, Ireland
Contact: Alison Sheerin, RN       alison.sheerin@gmail.com   
Sponsors and Collaborators
Katholieke Universiteit Leuven
Dublin City University
More Information

Additional Information:
Responsible Party: Roselien Buys, Dr, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT02717806     History of Changes
Other Study ID Numbers: S59023
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Cardiovascular Diseases