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

NCT06473441 | Not Yet Recruiting

• 1 other identifier: 202310018RIND
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Keywords

Acute coronary syndrome; Coronary artery disease; Cardiac rehabilitation; Telerehabilitation; Home-based training

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (3)

• Muscle strength

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

• Six-Minute Walk Test (6MWT)

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

• Sit-to-Stand Test

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

Other Outcomes (8)

• Depression Assessment (PHQ-9)

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

• Anxiety and Depression Assessment (HADS)

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

• Quality of Life Assessment (SF-36)

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

Study Arms (3)

12-Week Home Rehabilitation

EXPERIMENTAL

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.

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 Rehabilitation

EXPERIMENTAL

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.

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 Rehabilitation

EXPERIMENTAL

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.

Behavioral: Tele-Rehabilitation Therapy; Behavioral: Health Education; Behavioral: Exercise Prescription; Behavioral: Home Exercise Equipment Use; Behavioral: Exercise Log; Behavioral: Follow-Up Calls

Interventions

Tele-Rehabilitation Therapy BEHAVIORAL

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

12-Week Tele-Rehabilitation and Home Rehabilitation; 6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation

Health Education BEHAVIORAL

Health education based on individual assessments.

12-Week Home Rehabilitation; 12-Week Tele-Rehabilitation and Home Rehabilitation; 6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation

Exercise Prescription BEHAVIORAL

Exercise prescription tailored to individual needs.

12-Week Home Rehabilitation; 12-Week Tele-Rehabilitation and Home Rehabilitation; 6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation

Home Exercise Equipment Use BEHAVIORAL

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

12-Week Home Rehabilitation; 12-Week Tele-Rehabilitation and Home Rehabilitation; 6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation

Exercise Log BEHAVIORAL

Logging daily exercise intensity and duration in a rehabilitation diary

12-Week Home Rehabilitation; 12-Week Tele-Rehabilitation and Home Rehabilitation; 6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation

Follow-Up Calls BEHAVIORAL

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

12-Week Home Rehabilitation; 12-Week Tele-Rehabilitation and Home Rehabilitation; 6-Week Tele-Rehabilitation plus 6-Week Home Rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (7)

• 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.

  PMID: 25520374 BACKGROUND

• 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.

  PMID: 25888007 BACKGROUND

• 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.

  PMID: 28886621 BACKGROUND

• 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.

  PMID: 26730878 BACKGROUND

• 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.

  PMID: 22779092 BACKGROUND

• 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.

  PMID: 22345682 BACKGROUND

• 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.

  PMID: 23253876 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Shu-mei Yang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SHU-MEI YANG, MD

CONTACT

886-0972653754; b99401109@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 25, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share