Cardiac FailureNCT05761639
Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation
A study testing conventional rehabilitation, Education and telerehabilitation in people with Cardiac Failure, run by Clínica de Occidente S.A at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Failure
- What is being tested?
- conventional rehabilitation, Education and telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteColombia
- Study dates
- 15 Oct 2022to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Programa de Rehabilitacion
Cali, Valle del Cauca Department, 32
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Failure
- Being tested
- conventional rehabilitation, Education, telerehabilitation, follow-up
- Keywords
- Rehabilitation, telerehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional rehabilitationOther
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.
EducationBehavioural
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
telerehabilitationOther
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
follow-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Education; Other: telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: measured 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start15 Oct 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica de Occidente S.A
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jhonatan Betancourt Peña, PT, Principal investigator, Institucion Universitaria Escuela Nacional del Deporte - Universidad de Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761639
- Sponsor's protocol ID
- 0003
- Status last verified
- Oct 2024
- First submitted
- 6 Feb 2023
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Piotrowicz E, Pencina MJ, Opolski G, et al. Efectos de un programa de telerehabilitación integral híbrido de 9 semanas sobre los resultados a largo plazo en pacientes con insuficiencia cardíaca: ensayo clínico aleatorizado de telerehabilitación en pacientes con insuficiencia cardíaca (TELEREH-HF). JAMA Cardiol . 2020;5(3):300-308. doi:10.1001/jamacardio.2019.5006.
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
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.
PubMed 24849304Brouwers RWM, van Exel HJ, van Hal JMC, Jorstad HT, de Kluiver EP, Kraaijenhagen RA, Kuijpers PMJC, van der Linde MR, Spee RF, Sunamura M, Uszko-Lencer NHMK, Vromen T, Wittekoek ME, Kemps HMC; Committee for Cardiovascular Prevention and Cardiac Rehabilitation of the Netherlands Society of Cardiology. Cardiac telerehabilitation as an alternative to centre-based cardiac rehabilitation. Neth Heart J. 2020 Sep;28(9):443-451. doi: 10.1007/s12471-020-01432-y.
PubMed 32495296Frederix 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
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.
PubMed 28336297Bernocchi 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.
PubMed 28985325Peng 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.
PubMed 30170422Tam 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.
PubMed 32182131Tersalvi 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.
PubMed 33363223Kikuchi 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.
PubMed 33579602Piotrowicz 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.
PubMed 31734701Osorio 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.
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.
PubMed 40638607
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Telephone Follow-up Mediated by Cardiac Telerehabilitation in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT05761639
- Acronym / sponsor ID
- 0003
- Conditions
- Cardiac Failure
- Keywords
- Rehabilitation, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Clínica de Occidente S.AUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation, Education and Telephone Monitoring. | Experimental | Behavioral: Education, Other: telerehabilitation, Behavioral: 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. |
| conventional rehabilitation and Education | Experimental | Other: conventional rehabilitation, Behavioral: EducationThe 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 Education | Experimental | Behavioral: Education, Other: telerehabilitationTo 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional rehabilitationThe 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 | conventional rehabilitation and Education |
| Education1 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 | Behavioural | Telerehabilitation and Education, Telerehabilitation, Education and Telephone Monitoring., conventional rehabilitation and Education |
| telerehabilitationThe 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 | Telerehabilitation and Education, Telerehabilitation, Education and Telephone Monitoring. |
| follow-upTelephone 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. | Behavioural | Telerehabilitation, Education and Telephone Monitoring. |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- BackgroundEnfermedades 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
- BackgroundPiotrowicz E, Pencina MJ, Opolski G, et al. Efectos de un programa de telerehabilitación integral híbrido de 9 semanas sobre los resultados a largo plazo en pacientes con insuficiencia cardíaca: ensayo clínico aleatorizado de telerehabilitación en pacientes con insuficiencia cardíaca (TELEREH-HF). JAMA Cardiol . 2020;5(3):300-308. doi:10.1001/jamacardio.2019.5006.
- BackgroundTersalvi 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: PubMed 24849304Piotrowicz 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.
- Background: PubMed 32495296Brouwers RWM, van Exel HJ, van Hal JMC, Jorstad HT, de Kluiver EP, Kraaijenhagen RA, Kuijpers PMJC, van der Linde MR, Spee RF, Sunamura M, Uszko-Lencer NHMK, Vromen T, Wittekoek ME, Kemps HMC; Committee for Cardiovascular Prevention and Cardiac Rehabilitation of the Netherlands Society of Cardiology. Cardiac telerehabilitation as an alternative to centre-based cardiac rehabilitation. Neth Heart J. 2020 Sep;28(9):443-451. doi: 10.1007/s12471-020-01432-y.
- BackgroundFrederix 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: PubMed 28336297Hwang 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.
- Background: PubMed 28985325Bernocchi 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.
- Background: PubMed 30170422Peng 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.
- Background: PubMed 32182131Tam 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.
- Background: PubMed 33363223Tersalvi 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.
- Background: PubMed 33579602Kikuchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jhonatan Betancourt Peña, PT principal investigator
Institucion Universitaria Escuela Nacional del Deporte - Universidad de Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional rehabilitation, Education and telerehabilitation in people with Cardiac Failure, run by Clínica de Occidente S.A at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to exercise (time frame: measured 6 months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05761639, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.