The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs- a Randomized Controlled Trial

NCT06503445 | Completed

• 1 other identifier: 109-064-E
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac rehabilitation has the beneficial effects of secondary prevention and social psychological and physical health status in patients with cardiovascular diseases. International and clinical guidelines currently recommend exercise training and rehabilitation for heart failure patients, which can effectively improve mortality and prognosis. However, few of these recommendations have specific recommendations for patients with cardiac implantable electronic devices. Currently the recommendations of cardiac rehabilitation include patients with coronary heart disease (acute coronary heart disease, any coronary revascularization, stable coronary disease or unstable angina), patients with heart failure, after cardiac surgery, and patients with high cardiovascular risk. Many of these patients may be implanted with cardiac implantable electronic devices. In 2011, 938 pacemakers, 140 cardiac resynchronization therapy and 149 implantable cardioverter defibrillators were implanted per million inhabitants in Europe. Therefore, among the groups with cardiac implantable electronic devices, cardiac rehabilitation plays a certain role. The purpose of this study is to evaluate whether video-based cardiac rehabilitation health education for patients with cardiac implantable electronic devices has significantly improved physical activity. This study is designed as a prospective, single center, double-blind, randomized controlled trial. Divided into an experimental group and a control group at a ratio of 1:1. The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention, and the control group will receive only health education. We aim to recruit 45 participants per group with a total of 90 participants.

Conditions

Patients With Cardiac Implantable Electronic Devices

Keywords

Cardiac implantable electronic device; cardiac rehabilitation; video-based education

Outcome Measures

Primary Outcomes (1)

• Device measurement: physical activity

  use CIEDs to measure, it shows as how many hours of physical activity a day.

  We collected data on the day of case enrollment and twelve weeks later.

Secondary Outcomes (2)

• IPAQ, International Physical Activity Questionnaire

  We collected data on the day of case enrollment and between 12 to 24 weeks later.

• SF-36, short-form 36

  We collected data on the day of case enrollment and between 12 to 24 weeks later.

Study Arms (2)

Interventional group

EXPERIMENTAL

The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention.

Other: education video

Control group

SHAM COMPARATOR

The control group with cardiac implantable electronic devices will receive only health education video intervention.

Other: education video

Interventions

education video OTHER

the intervention group will watch the cardiac reahbiltation health education video. the control group will watch the health educatopm video.

Control group; Interventional group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-100 years old
• Patients with cardiovascular implantable electronic devices(CIEDs)
• CIEDs were implanted for more than 30 days without complications

You may not qualify if:

• cannot sign informed consent
• cannot return for follow-up visits current or scheduled enrollment in other conflicting studies
• concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months
• patients with bed-ridden status could not perform home-based tele-rehabilitation
• pregnancy

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

Related Publications (7)

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  PMID: 22718797 BACKGROUND

• Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.

  PMID: 23877260 BACKGROUND

• Pavy B, Iliou MC, Verges-Patois B, Brion R, Monpere C, Carre F, Aeberhard P, Argouach C, Borgne A, Consoli S, Corone S, Fischbach M, Fourcade L, Lecerf JM, Mounier-Vehier C, Paillard F, Pierre B, Swynghedauw B, Theodose Y, Thomas D, Claudot F, Cohen-Solal A, Douard H, Marcadet D; Exercise, Rehabilitation Sport Group (GERS); French Society of Cardiology. French Society of Cardiology guidelines for cardiac rehabilitation in adults. Arch Cardiovasc Dis. 2012 May;105(5):309-28. doi: 10.1016/j.acvd.2012.01.010. Epub 2012 Apr 16. No abstract available.

  PMID: 22709472 BACKGROUND

• Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009--a World Society of Arrhythmia's project. Pacing Clin Electrophysiol. 2011 Aug;34(8):1013-27. doi: 10.1111/j.1540-8159.2011.03150.x. Epub 2011 Jun 27.

  PMID: 21707667 BACKGROUND

• Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457.

  PMID: 19351942 BACKGROUND

• McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

  PMID: 25176015 BACKGROUND

• Calabro MA, Kim Y, Franke WD, Stewart JM, Welk GJ. Objective and subjective measurement of energy expenditure in older adults: a doubly labeled water study. Eur J Clin Nutr. 2015 Jul;69(7):850-5. doi: 10.1038/ejcn.2014.241. Epub 2014 Nov 5.

  PMID: 25351651 BACKGROUND

Study Officials

• Min-Tsun Liao, PHD

  National Taiwan University Hospital Hsin-Chu Branch Hsinchu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: March 3, 2021
• Primary Completion: April 20, 2022
• Study Completion: July 20, 2022
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)