NCT04121702

Brief Summary

The aim of this study is to establish an innovative Cardiac Tele-Rehabilitation (CTR) model. It could expands assistance resources through coordination with public administrations, developing a physical exercise program (PEP) assistance model in phase II that resolves the current situation of lack of adherence in the PEP due in part to the long waiting time to start it. To sum up this study could improve adherence in Cardiac Rehabilitation Phase III. It represents an opportunity to validate an innovative model for the realization of the PEP for phase II that could be expanded to other centres.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

1.6 years

First QC Date

June 17, 2019

Last Update Submit

October 9, 2019

Conditions

Acute Coronary SyndromeCardiac RehabilitationTelerehabilitationSecondary PreventionWearable Electronic DevicesExercise Therapy

Keywords

Cardiac RehabilitationTelerehabilitationSecondary PreventionWearable Electronic DevicesExercise Therapy

Outcome Measures

Primary Outcomes (2)

  • Adherence to physical exercise

    Adherence to physical exercise measured by number of physical exercise sessions realized by each patient

    At the end of the program (6 weeks)

  • Functional capacity

    Change of functional capacity measured by cardiopulmonary exercise test

    At the end of the program (6 weeks)

Secondary Outcomes (12)

  • Glucose levels

    At the end of the program (6 weeks)

  • Glycated hemoglobin levels (HbA1c)

    At the end of the program (6 weeks)

  • Low-density lipoprotein (LDL) levels

    At the end of the program (6 weeks)

  • High-density lipoprotein (HDL) levels

    At the end of the program (6 weeks)

  • Total colesterol levels

    At the end of the program (6 weeks)

  • +7 more secondary outcomes

Study Arms (2)

PEP-H

ACTIVE COMPARATOR

Physical exercise program at a hospital

Procedure: Cardiac Rehabilitation

PEP-PSC

EXPERIMENTAL

Physical exercise program with tele-monitoring in a public sport centre

Procedure: Cardiac Rehabilitation

Interventions

Cardiac RehabilitationPROCEDURE

Implementation of a physical exercise program (PEP) with tele-monitoring

PEP-HPEP-PSC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recent ACS (1-12 months) of low / moderate risk for the realization of a PEP and without physical impediments for it
  • Availability of a mobile phone with Android operating system where you can install the S-PATCH3-Cardio application
  • Patients who recognize that they are trained to operate the S-PATCH3-Cardio device after being instructed in its operation and perform a 24-hour simulation.
  • Signature of informed consent

You may not qualify if:

  • Baseline ergospirometry that does not reach maximalist criteria (respiratory quotient\> 1.1)
  • Mental disability
  • Associated comorbidity that prevents performing PEP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Juan Izquierdo Garcia, Therapist

    Hospital Universitario 12 de Octubre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Izquierdo Garcia, Therapist

CONTACT

+34917792077juan.izquierdo@salud.madrid.org

Guillermo Moreno Muñoz, Nurse

CONTACT

+34913908519guimoren@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Juan Izquierdo García, Physical Therapist, Principal Investigator

Study Record Dates

First Submitted

June 17, 2019

First Posted

October 10, 2019

Study Start

May 8, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 11, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)