Telehealth and Home-based Exercise and Rehabilitation Therapy for Acute Coronary Syndrome
NCT ID: NCT06473441
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-07-01
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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12-Week Home Rehabilitation
Participants 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.
Health Education
Health education based on individual assessments.
Exercise Prescription
Exercise prescription tailored to individual needs.
Home Exercise Equipment Use
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
Exercise Log
Logging daily exercise intensity and duration in a rehabilitation diary
Follow-Up Calls
Regular follow-up calls to monitor progress and address any issues.
6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation
Participants 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.
Tele-Rehabilitation Therapy
Twice-weekly sessions with remote supervision and guidance from therapists.
Health Education
Health education based on individual assessments.
Exercise Prescription
Exercise prescription tailored to individual needs.
Home Exercise Equipment Use
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
Exercise Log
Logging daily exercise intensity and duration in a rehabilitation diary
Follow-Up Calls
Regular follow-up calls to monitor progress and address any issues.
12-Week Tele-Rehabilitation and Home Rehabilitation
Participants 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.
Tele-Rehabilitation Therapy
Twice-weekly sessions with remote supervision and guidance from therapists.
Health Education
Health education based on individual assessments.
Exercise Prescription
Exercise prescription tailored to individual needs.
Home Exercise Equipment Use
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
Exercise Log
Logging daily exercise intensity and duration in a rehabilitation diary
Follow-Up Calls
Regular follow-up calls to monitor progress and address any issues.
Interventions
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Tele-Rehabilitation Therapy
Twice-weekly sessions with remote supervision and guidance from therapists.
Health Education
Health education based on individual assessments.
Exercise Prescription
Exercise prescription tailored to individual needs.
Home Exercise Equipment Use
Use of a home exercise bike, resistance bands, respiratory muscle training device, and a portable heart rate monitor.
Exercise Log
Logging daily exercise intensity and duration in a rehabilitation diary
Follow-Up Calls
Regular follow-up calls to monitor progress and address any issues.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Shu-mei Yang, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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202310018RIND
Identifier Type: -
Identifier Source: org_study_id
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