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CompletedNCT06503445CIEDsUpdated Sep 9, 2026

The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs

An interventional study of education video in Bradycardia, Arrhythmia and Heart Failure, sponsored by National Taiwan University Hospital Hsin-Chu Branch. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by National Taiwan University Hospital Hsin-Chu Branch · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Mar 2021, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
20 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bradycardia
  • Arrhythmia
  • Heart Failure

Keywords

  • Cardiac implantable electronic device
  • cardiac rehabilitation
  • video-based education
03

In context

Bradycardia

306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.

This study's enrollment of 85 is below the median of 99 across 174 interventional studies indexed under Bradycardia.

Browse Bradycardia studies →

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch is the lead sponsor of 35 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Cardiac rehabilitation

    receive cardiac rehabilitation health education video intervention

    Other: education video

  • Sham comparator
    general health

    receive only health education video intervention

    Other: education video

Interventions

  • Othereducation video

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

06

What researchers measure

Primary outcomes

  1. Device measurement: physical activity

    use Cardiovascular implantable electronic devices to measure, it shows as how many hours of physical activity a day.

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

Secondary outcomes

  1. International Physical Activity Questionnaire

    The total physical activity score is calculated by summing the duration and frequency of vigorous, moderate, and walking activities. Higher scores indicate a higher physical activity. Minimun score is 0 and there isn't a theoretical maximum score.

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

  2. short-form 36

    SF-36 is used to evaluate the "quality of life", range form 0-100. The survey results are interpreted in two main way: Domain Scores and Summary Scores. Higher scores represent better quality of life.

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

07

Study locations

1 site
  • National Taiwan University Hospital Hsin-Chu Branch
    Hsinchu, 300, Taiwan
08

References and documents

Publications

  • Piepoli MF, Corra U, Adamopoulos S, Benzer W, Bjarnason-Wehrens B, Cupples M, Dendale P, Doherty P, Gaita D, Hofer S, McGee H, Mendes M, Niebauer J, Pogosova N, Garcia-Porrero E, Rauch B, Schmid JP, Giannuzzi P. Secondary prevention in the clinical management of patients with cardiovascular diseases. Core components, standards and outcome measures for referral and delivery: a policy statement from the cardiac rehabilitation section of the European Association for Cardiovascular Prevention & Rehabilitation. Endorsed by the Committee for Practice Guidelines of the European Society of Cardiology. Eur J Prev Cardiol. 2014 Jun;21(6):664-81. doi: 10.1177/2047487312449597. Epub 2012 Jun 20. PubMed 22718797 ↗
  • 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. PubMed 23877260 ↗
  • 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. PubMed 22709472 ↗
  • 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. PubMed 21707667 ↗
  • 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. PubMed 19351942 ↗
  • 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. PubMed 25176015 ↗
  • 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. PubMed 25351651 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06503445
Lead sponsor
National Taiwan University Hospital Hsin-Chu Branch
Responsible party
Sponsor
First posted
Jul 16, 2024
Start date
Mar 3, 2021
Primary completion
Apr 20, 2022
Completion
Jul 20, 2022
Last update
Sep 9, 2026

Study contacts

Min-Tsun Liao, PHD
study director · National Taiwan University Hospital Hsin-Chu Branch Hsinchu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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