Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation

Sponsor

Clínica de Occidente S.A (Other)

Overall Status

Recruiting

CT.gov ID

NCT05761639

Collaborator

(none)

156

Enrollment

Location

Arms

12.2

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Failure	Other: conventional rehabilitation Other: Education Other: telerehabilitation Other: follow-up	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Oct 20, 2023

Arms and Interventions

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: 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 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 Other: 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.
Active Comparator: 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. Other: 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
Active Comparator: 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: 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 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

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: 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

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

Other: 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.

Active Comparator: 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.

Other: Education

Active Comparator: 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: Education

Other: telerehabilitation

Outcome Measures

Primary Outcome Measures

Adherence to exercise [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.
health-related quality of life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Programa de Rehabilitacion	Cali	Valle	Colombia	32

Sponsors and Collaborators

Clínica de Occidente S.A

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Clínica de Occidente S.A

ClinicalTrials.gov Identifier:

NCT05761639

Other Study ID Numbers:

0003

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 9, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Clínica de Occidente S.A

Rehabilitation

telerehabilitation

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Mar 9, 2023