NCT03102346

Brief Summary

Home-based CR (HBCR) was reported to improve the clinical outcomes of coronary artery disease (CAD) patients. There is no data published to investigate whether HBCR is also effective for Chinese CAD patients who have been revascularized. This trial was designed to investigate the safety and efficacy of CR program at home for Chinese patients who underwent PCI (Percutaneous Coronary Intervention) procedure. This is a multicenter, randomized, controlled and observational study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

November 9, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

3.7 years

First QC Date

March 25, 2017

Last Update Submit

April 15, 2019

Conditions

Coronary Artery Disease

Keywords

cardiorespiratory fitnesscoronary artery diseasecardiac rehabilitationremote controlmajor adverse cardiac and cerebrovascular events

Outcome Measures

Primary Outcomes (1)

  • MACCE(death, nonfatal myocardial infarction, revascularization, stroke)

    defined as the incidence of composite MACCE.

    during 12 months

Secondary Outcomes (4)

  • improvement of hospitalization due to refractory angina pectoris

    during 12 months

  • improvement of cardiorespiratory fitness

    during 12 months

  • improvement of life quality

    during 12 months

  • improvement of angina pectoris

    during 12 months

Study Arms (2)

Home-based Cardiac Rehabilitation group

EXPERIMENTAL

remote instructed exercise training at home

Other: home-based cardiac rehabilitation

routine group

NO INTERVENTION

no instructed exercise training

Interventions

home-based cardiac rehabilitationOTHER

The exercise training includes aerobic exercise (fast walking or cycling ,30-40 minutes per day,5-6 times a week), stretching exercise (15 minutes every time, 5-6 times a week), and resistance and balance training (each of 15 minutes every time, twice to 3 times a week).

Also known as: exercise training at home
Home-based Cardiac Rehabilitation group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all of them
  • age range from 30 to 80.
  • coronary artery disease,revascularized with stent deployment.
  • New York Heart Association (NYHA) classification Class I-III.
  • Good cognitive level.
  • Ability to perform aerobic exercise.
  • Understand be able to use a mobile smart phone by himself or with help of family members.
  • Signature of informed consent. The informed consent will be valid for the duration of the trial or until the subject withdraws.

You may not qualify if:

  • Presence of malignant arrhythmias such as ventricular fibrillation outside the acute phase of Acute myocardial infarction (AMI) (\> 24 h after AMI), ventricular tachycardia, Atrioventricular block of 2nd degree and 3rd degree, Atrial fibrilation (FA) in patients with Wolf Parkinson White, fibrillation or paroxysmal atrial flutter with response ventricular quickly and hemodynamic deterioration, premature ventricular contractions increases during exertion, paroxysmal supraventricular tachycardia uncontrolled.
  • Hypotensive response to exercise.
  • acute myocardial infarction within 2 weeks
  • Poorly controlled hypertension baseline,hyperglycemia,respiratory failure.
  • severe pulmonary hypertension
  • acute phase of heart failure
  • Pathology of musculoskeletal, neurological or breathing that impair the ability of prolonged ambulation.
  • Pregnant women.
  • Subjects unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First People's Hospital of Yunnan Province

Kunming, Yunnan, 650032, China

RECRUITING

Related Publications (7)

  • DeBusk RF, Miller NH, Parker KM, Bandura A, Kraemer HC, Cher DJ, West JA, Fowler MB, Greenwald G. Care management for low-risk patients with heart failure: a randomized, controlled trial. Ann Intern Med. 2004 Oct 19;141(8):606-13. doi: 10.7326/0003-4819-141-8-200410190-00008.

    PMID: 15492340BACKGROUND

  • Haskell WL, Alderman EL, Fair JM, Maron DJ, Mackey SF, Superko HR, Williams PT, Johnstone IM, Champagne MA, Krauss RM, et al. Effects of intensive multiple risk factor reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease. The Stanford Coronary Risk Intervention Project (SCRIP). Circulation. 1994 Mar;89(3):975-90. doi: 10.1161/01.cir.89.3.975.

    PMID: 8124838BACKGROUND

  • Froelicher V, Jensen D, Genter F, Sullivan M, McKirnan MD, Witztum K, Scharf J, Strong ML, Ashburn W. A randomized trial of exercise training in patients with coronary heart disease. JAMA. 1984 Sep 14;252(10):1291-7.

    PMID: 6381770BACKGROUND

  • Newton M, Mutrie N, McArthur JD. The effects of exercise in a coronary rehabilitation programme. Scott Med J. 1991 Apr;36(2):38-41. doi: 10.1177/003693309103600203.

    PMID: 1853191BACKGROUND

  • Conraads VM, Van Craenenbroeck EM, Pattyn N, Cornelissen VA, Beckers PJ, Coeckelberghs E, De Maeyer C, Denollet J, Frederix G, Goetschalckx K, Hoymans VY, Possemiers N, Schepers D, Shivalkar B, Vanhees L. Rationale and design of a randomized trial on the effectiveness of aerobic interval training in patients with coronary artery disease: the SAINTEX-CAD study. Int J Cardiol. 2013 Oct 9;168(4):3532-6. doi: 10.1016/j.ijcard.2013.05.007. Epub 2013 May 24.

    PMID: 23711446BACKGROUND

  • Soga Y, Yokoi H, Amemiya K, Iwabuchi M, Nobuyoshi M. Safety and efficacy of exercise training after coronary stenting in patients with stable coronary artery disease. Circ J. 2011;75(10):2379-86. doi: 10.1253/circj.cj-11-0470. Epub 2011 Jul 28.

    PMID: 21799272BACKGROUND

  • Perez-Terzic CM. Exercise in cardiovascular diseases. PM R. 2012 Nov;4(11):867-73. doi: 10.1016/j.pmrj.2012.10.003.

    PMID: 23174552BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Yundai Chen, MD,PHD

    Director of department of Cardiology, Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ma, MD,PHD

CONTACT

86-10-66935316crystalma_301@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Cardiology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 25, 2017

First Posted

April 5, 2017

Study Start

November 9, 2017

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)