Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation

NCT05761639 | Active Not Recruiting DMC

• 1 other identifier: 0003
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Failure

Keywords

Rehabilitation; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  measured 6 months after the intervention

• 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.

  measured 6 months after the intervention

Study Arms (3)

Telerehabilitation, Education and Telephone Monitoring.

EXPERIMENTAL

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.

Behavioral: Education; Other: telerehabilitation; Behavioral: follow-up

conventional rehabilitation and Education

EXPERIMENTAL

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; Behavioral: Education

Telerehabilitation and Education

EXPERIMENTAL

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.

Behavioral: Education; Other: telerehabilitation

Interventions

conventional rehabilitation OTHER

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.

conventional rehabilitation and Education

Education BEHAVIORAL

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

Telerehabilitation and Education; Telerehabilitation, Education and Telephone Monitoring.; conventional rehabilitation and Education

telerehabilitation OTHER

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

Telerehabilitation and Education; Telerehabilitation, Education and Telephone Monitoring.

follow-up BEHAVIORAL

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.

Telerehabilitation, Education and Telephone Monitoring.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Clínica de Occidente S.A: lead

Study Sites (1)

Programa de Rehabilitacion

Cali, Valle del Cauca Department, 32, Colombia

Location

Related Publications (14)

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  BACKGROUND

• Piotrowicz E, Pencina MJ, Opolski G, Zareba W, Banach M, Kowalik I, Orzechowski P, Szalewska D, Pluta S, Glowczynska R, Irzmanski R, Oreziak A, Kalarus Z, Lewicka E, Cacko A, Mierzynska A, Piotrowicz R. Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial. JAMA Cardiol. 2020 Mar 1;5(3):300-308. doi: 10.1001/jamacardio.2019.5006.

  PMID: 31734701 BACKGROUND

• Tersalvi G, Winterton D, Cioffi GM, et al. Telemedicina en insuficiencia cardíaca durante COVID-19: un paso hacia el futuro. Delantero Cardiovasc Med . 2020;7:612818. Publicado el 9 de diciembre de 2020. doi:10.3389/fcvm.2020.612818

  BACKGROUND

• Piotrowicz E, Stepnowska M, Leszczynska-Iwanicka K, Piotrowska D, Kowalska M, Tylka J, Piotrowski W, Piotrowicz R. Quality of life in heart failure patients undergoing home-based telerehabilitation versus outpatient rehabilitation--a randomized controlled study. Eur J Cardiovasc Nurs. 2015 Jun;14(3):256-63. doi: 10.1177/1474515114537023. Epub 2014 May 21.

  PMID: 24849304 BACKGROUND

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  PMID: 32495296 BACKGROUND

• Frederix I, Hansen D, Coninx K, et al. Telerehabilitación III: un ensayo multicéntrico, aleatorizado y controlado que investiga la eficacia a largo plazo de un programa integral de telerehabilitación cardíaca: justificación y diseño del estudio. Trastorno cardiovascular BMC . 2015;15:29. Publicado el 7 de mayo de 2015. doi:10.1186/s12872-015-0021-5

  BACKGROUND

• Hwang R, Bruning J, Morris NR, Mandrusiak A, Russell T. Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial. J Physiother. 2017 Apr;63(2):101-107. doi: 10.1016/j.jphys.2017.02.017. Epub 2017 Mar 14.

  PMID: 28336297 BACKGROUND

• Bernocchi P, Vitacca M, La Rovere MT, Volterrani M, Galli T, Baratti D, Paneroni M, Campolongo G, Sposato B, Scalvini S. Home-based telerehabilitation in older patients with chronic obstructive pulmonary disease and heart failure: a randomised controlled trial. Age Ageing. 2018 Jan 1;47(1):82-88. doi: 10.1093/ageing/afx146.

  PMID: 28985325 BACKGROUND

• Peng X, Su Y, Hu Z, Sun X, Li X, Dolansky MA, Qu M, Hu X. Home-based telehealth exercise training program in Chinese patients with heart failure: A randomized controlled trial. Medicine (Baltimore). 2018 Aug;97(35):e12069. doi: 10.1097/MD.0000000000012069.

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• Tam CF, Cheung KS, Lam S, Wong A, Yung A, Sze M, Lam YM, Chan C, Tsang TC, Tsui M, Tse HF, Siu CW. Impact of Coronavirus Disease 2019 (COVID-19) Outbreak on ST-Segment-Elevation Myocardial Infarction Care in Hong Kong, China. Circ Cardiovasc Qual Outcomes. 2020 Apr;13(4):e006631. doi: 10.1161/CIRCOUTCOMES.120.006631. Epub 2020 Mar 17. No abstract available.

  PMID: 32182131 BACKGROUND

• Tersalvi G, Winterton D, Cioffi GM, Ghidini S, Roberto M, Biasco L, Pedrazzini G, Dauw J, Ameri P, Vicenzi M. Telemedicine in Heart Failure During COVID-19: A Step Into the Future. Front Cardiovasc Med. 2020 Dec 9;7:612818. doi: 10.3389/fcvm.2020.612818. eCollection 2020.

  PMID: 33363223 BACKGROUND

• Kikuchi A, Taniguchi T, Nakamoto K, Sera F, Ohtani T, Yamada T, Sakata Y. Feasibility of home-based cardiac rehabilitation using an integrated telerehabilitation platform in elderly patients with heart failure: A pilot study. J Cardiol. 2021 Jul;78(1):66-71. doi: 10.1016/j.jjcc.2021.01.010. Epub 2021 Feb 10.

  PMID: 33579602 BACKGROUND

• Osorio MAM. Del Modelo Biomédico al Modelo Biopsicosocial: El desafío pendiente para la fisioterapia en el dolor músculoesquelético crónico. Revista Facultad de Ciencias de la Salud UDES. 2016;3(2):97-101.

  BACKGROUND

• Betancourt-Pena J, Portela-Pino I, Martinez-Patino MJ. Study protocol for a controlled clinical trial on cardiac telerehabilitation and educational follow-up in patients with heart failure. PLoS One. 2025 Jul 10;20(7):e0327366. doi: 10.1371/journal.pone.0327366. eCollection 2025.

  PMID: 40638607 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Educational Status; Telerehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jhonatan Betancourt Peña, PT

  Institucion Universitaria Escuela Nacional del Deporte - Universidad de Vigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 9, 2023
• Study Start: October 15, 2022
• Primary Completion: December 20, 2024
• Study Completion: June 20, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)