Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation

November 19, 2023 updated by: Clínica de Occidente S.A

Physical Exercise and Telephone Follow-up Mediated by Cardiac Telerehabilitation in Patients With Heart Failure

Cardiovascular diseases are the leading cause of death and disability globally, accounting for approximately 31% (17.9 million) of all deaths each year. The COVID-19 pandemic has led to the total suspension of most cardiac rehabilitation programs at the highest peaks of the spread, forcing people not to leave home, enhancing metabolic conditions and generating further complications due to sedentary lifestyle. Physical exercise is an essential component in the rehabilitation of patients with heart failure disease, evidencing improvements in quality of life, functional capacity, in addition to reducing the mortality rate, number of rehospitalizations, and levels of depression. It is necessary to carry out interventions adapted to the needs of patients who have difficulties traveling to health centers, however, some authors report that remotely oriented exercise could present results similar to those of traditional rehabilitation in a center or Therefore, promoting a cardiac telerehabilitation program together with telephone educational follow-up could cause greater improvements compared to other cardiac rehabilitation and telerehabilitation programs.

Objective: To determine the effects of a physical exercise program and telephone educational follow-up mediated by cardiac telerehabilitation in patients with heart failure on functional capacity, depression, and health-related quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled clinical trial type study will be carried out, in a period of 6 months between the year 2022, in patients with a diagnosis of heart failure who enter a cardiac rehabilitation program in the city of Santiago de Cali, Colombia, linking to the research after the consultation with cardiology in three groups: physical exercise program and conventional educational component with telephone follow-up (Intervention), physical exercise program and conventional educational component mediated by cardiac telerehabilitation, to which measurements of sociodemographic variables and clinical before-after measurements (physiological, paraclinical, anthropometric) functional capacity, quality of life and state of depression.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
    • Valle
      • Cali, Valle, Colombia, 32
        • Recruiting
        • Programa de Rehabilitacion
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jhonatan Betancourt, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients previously diagnosed by a Cardiology Specialist with heart failure.
  • Patients who present an indication to exercise.
  • Patients who have digital equipment such as a computer, tablet or cell phone with access to virtual platforms to carry out exercise sessions mediated by technology.
  • Participants who accept and sign the informed consent.

Exclusion Criteria:

  • Patients with respiratory comorbidity or who present some limitation to perform active and resisted movements (recent fractures, recent hemodynamic alterations, coronary disease event after the diagnosis of cardiovascular disease, infectious diseases and neuromuscular limitation).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation, Education and Telephone Monitoring.

The effects of a physical exercise program and educational component with telephone follow-up mediated by cardiac telerehabilitation in patients with heart failure on functional capacity, depression and health-related quality of life will be determined.

Each participant will be given a polar FT4 brand frequency monitor to record their HR, an OMRON brand digital blood pressure monitor to monitor blood pressure and the conventional Borg scale will be used for perception of exertion during exercise.
Other: telerehabilitation
The program will be assisted by virtual technology and consists of physical exercise at home (for 60 minutes, 3 times a week for a period of 12 weeks, structured by warming up, muscle strengthening of lower and upper limbs, continuous aerobic training and cool down ) supervised by a physiotherapist specializing in cardiac and pulmonary rehabilitation through the "Google Meet" platform
Behavioral: Education
1 time a week 30 minutes for each patient individually and in a group with topics: knowledge of the disease, use of medications, warning signs, anxiety management, relaxation techniques, exercises at home, sexual relations and adequate nutrition
Behavioral: follow-up
Telephone calls will be made 3 times a week as a follow-up method to obtain information from each person about their heart rate and perception of effort in relation to the activities carried out where they are encouraged to exercise at home on days without intervention.
Experimental: conventional rehabilitation and Education
The effects of a physical exercise program and a conventional educational component in patients with heart failure on functional capacity, depression and health-related quality of life will be determined. The development of this program will be carried out in person guided by a physiotherapist specializing in cardiac and pulmonary rehabilitation.
Other: conventional rehabilitation
The program will be attended in person in the clinic's cardiac rehabilitation program and consists of physical exercise supervised by a physiotherapist specializing in cardiac and pulmonary rehabilitation, for 60 minutes, 3 times a week for a period of 12 weeks, structured by warming up. , muscle strengthening of lower and upper limbs, continuous aerobic training and return to calm.
Behavioral: Education
1 time a week 30 minutes for each patient individually and in a group with topics: knowledge of the disease, use of medications, warning signs, anxiety management, relaxation techniques, exercises at home, sexual relations and adequate nutrition
Experimental: Telerehabilitation and Education

To determine the effects of a physical exercise program and a conventional educational component mediated by cardiac telerehabilitation in patients with heart failure on functional capacity, depression, and health-related quality of life

Each participant will be given a polar FT4 brand frequency monitor to record their HR, an OMRON brand digital blood pressure monitor to monitor blood pressure and the conventional Borg scale will be used for perception of exertion during exercise.
Other: telerehabilitation
The program will be assisted by virtual technology and consists of physical exercise at home (for 60 minutes, 3 times a week for a period of 12 weeks, structured by warming up, muscle strengthening of lower and upper limbs, continuous aerobic training and cool down ) supervised by a physiotherapist specializing in cardiac and pulmonary rehabilitation through the "Google Meet" platform
Behavioral: Education
1 time a week 30 minutes for each patient individually and in a group with topics: knowledge of the disease, use of medications, warning signs, anxiety management, relaxation techniques, exercises at home, sexual relations and adequate nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to exercise
Time Frame: measured 6 months after the intervention
Practicing physical activity as a principle of self-determination and converting it into a healthy lifestyle or habit and aerobic capacity will be measured by completing 85% of sessions (21 sessions) of cardiac rehabilitation, including education and telephone follow-up.
measured 6 months after the intervention
health-related quality of life
Time Frame: measured 6 months after the intervention

A generic concept that reflects the concern for the modification and improvement of the attributes of life, for example, the physical, political, moral, social environment, as well as health and disease.

It is applied with the Saint George's Questionnaire (SGRQ), this scale goes from 0 to 100 points, high scores indicate that the patient is unwell and low scores the patient is better and a decrease of 4 points after an intervention is considered clinically significant.
measured 6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica de Occidente S.A

Investigators

  • Principal Investigator: Jhonatan Betancourt Peña, PT, Institucion Universitaria Escuela Nacional del Deporte - Universidad de Vigo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

December 20, 2023

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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