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Acute Coronary SyndromeTELE-HEARTNCT06473441

Telehealth and Home-based Exercise and Rehabilitation Therapy for Acute Coronary Syndrome

A study testing Tele-Rehabilitation Therapy, Health Education and Exercise Prescription in people with Acute Coronary Syndrome and Coronary Artery Disease, run by National Taiwan University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to compare the effectiveness of three different home-based rehabilitation programs for patients with acute coronary syndrome (ACS). This randomized controlled trial will recruit 60 ACS patients, divided into three groups: a 12-week home rehabilitation group, a 6-week tele-rehabilitation followed by… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tele-Rehabilitation Therapy, Health Education and Exercise Prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Jul 2024to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hospitalized for acute coronary syndrome (ACS) and have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery.
  • Aged 18 years or older.
  • Regular adherence to prescribed medication regimen.
  • Stable medical condition and vital signs.
  • Conscious and able to follow instructions.
  • Able to provide informed consent.

Who cannot join

  • Unable to comply with rehabilitation or assessment procedures.
  • Inability to walk independently.
  • Dependent in daily living activities prior to hospitalization (Barthel Index score less than 80).
  • Terminal illness with an expected life span of less than one year. Contraindications to cardiac rehabilitation as per the American College of Sports Medicine guidelines, such as unstable angina, uncontrolled severe hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg), postural hypotension (blood pressure drop of more than 20 mmHg upon standing), severe aortic stenosis, uncontrolled severe arrhythmias, decompensated heart failure, third-degree atrioventricular block, acute pericarditis or myocarditis, aortic dissection, acute pulmonary embolism, and other acute medical conditions like infections and fever.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

SHU-MEI YANG, MD contact

886-0972653754

b99401109@gmail.com

About this study

Official title: Comparative Effectiveness of Three Home-Based Rehabilitation Programs in Patients With Acute Coronary Syndrome: A Randomized Controlled Trial

This study aims to compare the effectiveness of three different home-based rehabilitation programs for patients with acute coronary syndrome (ACS). This randomized controlled trial will recruit 60 ACS patients, divided into three groups: a 12-week home rehabilitation group, a 6-week tele-rehabilitation followed by 6-week home rehabilitation group, and a 12-week tele-rehabilitation combined with home rehabilitation group. Patients will be assessed at baseline, and at 3, 6, and 12 months on physical health, cardiopulmonary function, and psychological well-being. The hypothesis is that home-based CR, particularly with tele-rehabilitation, will improve recovery and quality of life more effectively. The study aims to identify the most beneficial home rehabilitation strategy for ACS patients.

Read the detailed description

This study is designed to evaluate the benefits of three different home-based cardiac rehabilitation (CR) models on the recovery of patients with acute coronary syndrome (ACS). Cardiovascular diseases are a major cause of mortality worldwide, but advancements in CR have significantly improved patient outcomes. Despite the proven benefits of CR in enhancing quality of life and reducing hospital readmission rates, participation in traditional CR programs remains low. Home-based CR, especially using tele-rehabilitation technologies, offers a promising alternative. This randomized controlled trial will recruit 60 ACS patients, divided into three groups: a 12-week home rehabilitation group, a 6-week tele-rehabilitation followed by a 6-week home rehabilitation group, and a 12-week tele-rehabilitation combined with home rehabilitation group. All patients will undergo evaluations at baseline, and at 3, 6, and 12 months to assess physical health, cardiopulmonary function, and psychological well-being. The hypothesis is that home-based CR, particularly with tele-rehabilitation support, will enhance recovery and quality of life more effectively than traditional methods. The findings aim to identify the most effective home rehabilitation strategy for ACS patients, providing insights into improving their cardiopulmonary function and overall well-being.

Being tested
Tele-Rehabilitation Therapy, Health Education, Exercise Prescription, Home Exercise Equipment Use, Exercise Log
Keywords
Acute coronary syndrome, Coronary artery disease, Cardiac rehabilitation, Telerehabilitation, Home-based training
Medical subject headings
Acute Coronary Syndrome, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-Rehabilitation TherapyBehavioural

    Twice-weekly sessions with remote supervision and guidance from therapists.

  • Health EducationBehavioural

    Health education based on individual assessments.

  • Exercise PrescriptionBehavioural

    Exercise prescription tailored to individual needs.

  • Home Exercise Equipment UseBehavioural

    Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.

  • Exercise LogBehavioural

    Logging daily exercise intensity and duration in a rehabilitation diary

  • Follow-Up CallsBehavioural

    Regular follow-up calls to monitor progress and address any issues.

Study groups in NCT06473441
Study groupRoleWhat they receive
12-Week Home RehabilitationExperimentalParticipants in this group will receive a 12-week home-based rehabilitation program. They will be provided with health education and an exercise prescription based on individual assessments by the research team. Rehabilitation equipment, including a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor, will be supplied. Participants will log their daily exercise intensity and duration in a rehabilitation diary. Regular follow-up calls will be made to monitor progress and address any issues.
Receives: Behavioral: Health Education; Behavioral: Exercise Prescription; Behavioral: Home Exercise Equipment Use; Behavioral: Exercise Log; Behavioral: Follow-Up Calls
6-Week Tele-Rehabilitation plus 6-Week Home RehabilitationExperimentalParticipants in this group will undergo a hybrid rehabilitation program. For the first 6 weeks, they will receive tele-rehabilitation therapy, involving twice-weekly sessions where therapists remotely supervise and guide exercises. This will be followed by 6 weeks of the same home rehabilitation program as Arm 1, with health education, exercise prescriptions, and regular follow-up calls.
Receives: Behavioral: Tele-Rehabilitation Therapy; Behavioral: Health Education; Behavioral: Exercise Prescription; Behavioral: Home Exercise Equipment Use; Behavioral: Exercise Log; Behavioral: Follow-Up Calls
12-Week Tele-Rehabilitation and Home RehabilitationExperimentalParticipants in this group will receive 12 weeks of combined tele-rehabilitation and home rehabilitation. They will have twice-weekly tele-rehabilitation sessions with remote supervision and guidance from therapists throughout the entire period. In addition, they will follow the same home rehabilitation protocol as described for Arm 1, with provided equipment, exercise logs, and regular follow-up calls to ensure adherence and address any difficulties.
Receives: Behavioral: Tele-Rehabilitation Therapy; Behavioral: Health Education; Behavioral: Exercise Prescription; Behavioral: Home Exercise Equipment Use; Behavioral: Exercise Log; Behavioral: Follow-Up Calls

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Oxygen Uptake (VO2 max)

    his measure will evaluate cardiopulmonary function by assessing the maximal oxygen uptake (VO2 max). VO2 max is the maximum amount of oxygen the body can utilize during intense exercise and is an indicator of cardiovascular and respiratory efficiency.

    Measured: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

  2. Anaerobic Threshold

    This measure will evaluate cardiopulmonary function by assessing the anaerobic threshold. The anaerobic threshold is the exercise intensity at which lactate begins to accumulate in the blood, indicating the transition from aerobic to anaerobic metabolism.

    Measured: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

  3. Oxygen Pulse

    This measure will evaluate cardiopulmonary function by assessing the oxygen pulse, which is the amount of oxygen used by the body per heartbeat during exercise. It provides insights into cardiovascular efficiency and respiratory function.

    Measured: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

Secondary outcomes (3)

  1. Muscle strength

    This measure will assess physical function through the muscle strength tests (manual muscle testing). These tests will evaluate improvements in participants' muscular strength and endurance by measuring the maximum force that muscles can exert against resistance.

    Measured: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

  2. Six-Minute Walk Test (6MWT)

    This measure will assess physical function through the six-minute walk test (6MWT). The test evaluates improvements in participants' walking endurance and overall physical capabilities.

    Measured: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

  3. Sit-to-Stand Test

    This measure will assess physical function through the sit-to-stand test. The test evaluates improvements in participants' lower body strength and functional mobility.

    This measure will assess physical function through the sit-to-stand test. The test evaluates improvements in participants' lower body strength and functional mobility.

    This measure will assess physical function through the sit-to-stand test. The test evaluates improvements in participants' lower body strength and functional mobility.

    Measured: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06473441
Sponsor's protocol ID
202310018RIND
Acronym
TELE-HEART
Status last verified
May 2024
First submitted
27 May 2024
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.

    PubMed 25520374

  • de Vries H, Kemps HM, van Engen-Verheul MM, Kraaijenhagen RA, Peek N. Cardiac rehabilitation and survival in a large representative community cohort of Dutch patients. Eur Heart J. 2015 Jun 21;36(24):1519-28. doi: 10.1093/eurheartj/ehv111. Epub 2015 Apr 17.

    PubMed 25888007

  • Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

    PubMed 28886621

  • Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.

    PubMed 26730878

  • Neubeck L, Freedman SB, Clark AM, Briffa T, Bauman A, Redfern J. Participating in cardiac rehabilitation: a systematic review and meta-synthesis of qualitative data. Eur J Prev Cardiol. 2012 Jun;19(3):494-503. doi: 10.1177/1741826711409326.

    PubMed 22779092

  • De Vos C, Li X, Van Vlaenderen I, Saka O, Dendale P, Eyssen M, Paulus D. Participating or not in a cardiac rehabilitation programme: factors influencing a patient's decision. Eur J Prev Cardiol. 2013 Apr;20(2):341-8. doi: 10.1177/2047487312437057. Epub 2012 Jan 20.

    PubMed 22345682

  • Oerkild B, Frederiksen M, Hansen JF, Prescott E. Home-based cardiac rehabilitation is an attractive alternative to no cardiac rehabilitation for elderly patients with coronary heart disease: results from a randomised clinical trial. BMJ Open. 2012 Dec 18;2(6):e001820. doi: 10.1136/bmjopen-2012-001820. Print 2012.

    PubMed 23253876

Questions about this trial

What is this clinical trial studying?

A study testing Tele-Rehabilitation Therapy, Health Education and Exercise Prescription in people with Acute Coronary Syndrome and Coronary Artery Disease, run by National Taiwan University Hospital.

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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SHU-MEI YANG, MD (886-0972653754, b99401109@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Oxygen Uptake (VO2 max) (time frame: Assessments will be conducted at baseline (week 0), and at 3, 6, and 12 months post-intervention.). The study lists 3 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 NCT06473441, which also lists 7 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 25 Jun 2024.

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