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Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation

Primary Purpose

Cardiac Failure

Status
Recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
conventional rehabilitation
Education
telerehabilitation
follow-up
Sponsored by
Clínica de Occidente S.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Failure focused on measuring Rehabilitation, telerehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Programa de RehabilitacionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Telerehabilitation, Education and Telephone Monitoring.

conventional rehabilitation and Education

Telerehabilitation and Education

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Adherence to exercise
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
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

Full Information

First Posted
February 6, 2023
Last Updated
April 2, 2023
Sponsor
Clínica de Occidente S.A
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1. Study Identification

Unique Protocol Identification Number
NCT05761639
Brief Title
Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation
Official Title
Physical Exercise and Telephone Follow-up Mediated by Cardiac Telerehabilitation in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clínica de Occidente S.A

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Failure
Keywords
Rehabilitation, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation, Education and Telephone Monitoring.
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional rehabilitation and Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Telerehabilitation and Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
conventional rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
telerehabilitation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to exercise
Description
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.
Time Frame
measured 6 months after the intervention
Title
health-related quality of life
Description
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.
Time Frame
measured 6 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Ávila, PT
Phone
3013369979
Email
rhcardiopulmonar09@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jhonatan Betancourt Peña, PT
Phone
3177602534
Email
johnnatanbp@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jhonatan Betancourt Peña, PT
Organizational Affiliation
Institucion Universitaria Escuela Nacional del Deporte - Universidad de Vigo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Programa de Rehabilitacion
City
Cali
State/Province
Valle
ZIP/Postal Code
32
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Avila, PT
Phone
3013369979
Email
rhcardiopulmonar099@gmail.com
First Name & Middle Initial & Last Name & Degree
Jhonatan Betancourt, PT
Phone
3177602534
Email
johnnatanbp@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jhonatan Betancourt, PT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Enfermedades Cardiovasculares. Prevención y control de las enfermedades no transmisibles [Internet]. OMS. 2016 [citado 19 octubre 2021]. Disponible en: https://www.paho.org/es/temas/enfermedades-cardiovasculares. Organización Mundial de la Salud. Estrategia mundial para la prevención y el control de las enfermedades no transmisibles. 2000
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Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation

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