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

NCT ID: NCT06473441

Last Updated: 2024-06-25

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Coronary Syndrome Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Health Education

Intervention Type BEHAVIORAL

Health education based on individual assessments.

Exercise Prescription

Intervention Type BEHAVIORAL

Exercise prescription tailored to individual needs.

Home Exercise Equipment Use

Intervention Type BEHAVIORAL

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

Exercise Log

Intervention Type BEHAVIORAL

Logging daily exercise intensity and duration in a rehabilitation diary

Follow-Up Calls

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Tele-Rehabilitation Therapy

Intervention Type BEHAVIORAL

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

Health Education

Intervention Type BEHAVIORAL

Health education based on individual assessments.

Exercise Prescription

Intervention Type BEHAVIORAL

Exercise prescription tailored to individual needs.

Home Exercise Equipment Use

Intervention Type BEHAVIORAL

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

Exercise Log

Intervention Type BEHAVIORAL

Logging daily exercise intensity and duration in a rehabilitation diary

Follow-Up Calls

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Tele-Rehabilitation Therapy

Intervention Type BEHAVIORAL

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

Health Education

Intervention Type BEHAVIORAL

Health education based on individual assessments.

Exercise Prescription

Intervention Type BEHAVIORAL

Exercise prescription tailored to individual needs.

Home Exercise Equipment Use

Intervention Type BEHAVIORAL

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

Exercise Log

Intervention Type BEHAVIORAL

Logging daily exercise intensity and duration in a rehabilitation diary

Follow-Up Calls

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Health Education

Health education based on individual assessments.

Intervention Type BEHAVIORAL

Exercise Prescription

Exercise prescription tailored to individual needs.

Intervention Type BEHAVIORAL

Home Exercise Equipment Use

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

Intervention Type BEHAVIORAL

Exercise Log

Logging daily exercise intensity and duration in a rehabilitation diary

Intervention Type BEHAVIORAL

Follow-Up Calls

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu-mei Yang, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

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SHU-MEI YANG, MD

Role: CONTACT

886-0972653754

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.

Reference Type BACKGROUND
PMID: 25520374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25888007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28886621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26730878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22779092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22345682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23253876 (View on PubMed)

Other Identifiers

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202310018RIND

Identifier Type: -

Identifier Source: org_study_id

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