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Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation

Not Applicable
Active, not recruiting
Conditions
Cardiac Failure
Interventions
Other: conventional rehabilitation
Other: telerehabilitation
Behavioral: Education
Behavioral: follow-up
Registration Number
NCT05761639
Lead Sponsor
Clínica de Occidente S.A
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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
156
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
conventional rehabilitation and Educationconventional rehabilitationThe 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.
Telerehabilitation, Education and Telephone Monitoring.telerehabilitationThe 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.
conventional rehabilitation and EducationEducationThe 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.
Telerehabilitation and EducationtelerehabilitationTo 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.
Telerehabilitation, Education and Telephone Monitoring.EducationThe 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.
Telerehabilitation and EducationEducationTo 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.
Telerehabilitation, Education and Telephone Monitoring.follow-upThe 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.
Primary Outcome Measures
NameTimeMethod
Adherence to exercisemeasured 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 lifemeasured 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Programa de Rehabilitacion

🇨🇴

Cali, Valle, Colombia

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