We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3604 for:    PATHway
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified July 2017 by Roselien Buys, Katholieke Universiteit Leuven
Sponsor:
ClinicalTrials.gov Identifier:
NCT02717806
First Posted: March 24, 2016
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Dublin City University
Information provided by (Responsible Party):
Roselien Buys, Katholieke Universiteit Leuven
  Purpose

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 Intervention
Cardiovascular Disease Behavioral: PATHway

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Roselien Buys, Katholieke Universiteit Leuven:

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

Estimated Enrollment: 120
Study Start Date: January 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium
Contact: Roselien Buys, PhD       roselien.buys@kuleuven.be   
Ireland
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 Submitted: March 18, 2016
First Posted: March 24, 2016
Last Update Posted: July 19, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Cardiovascular Diseases