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efficAcy and Safety of Home-baSed Cardiac rehabIlitation in ChineSe Revascularized patienTs (ASSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102346
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yun Dai Chen, Chinese PLA General Hospital

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: home-based cardiac rehabilitation Not Applicable

Detailed Description:

Numerous studies have revealed that cardiac rehabilitation (CR) after myocardial Cardiac rehabilitation (CR) after revascularization results in better clinical outcomes, and have been strongly recommended for patients with coronary artery disease. In China, as compared to the exponential increase of PCI (Percutaneous Coronary Intervention) volume, only a very small amount of hospitals are able to develop CR programs. There is no large-scale study to explore the feasible CR pattern either. Home-based CR might be more favorable and practical for so many Chinese revascularized coronary artery disease (CAD) patients due to its feasibility and flexibility as well as low medical cost.

This trial was designed to investigate the safety and efficacy of CR program at home for Chinese patients who underwent PCI procedure. This is a multicenter, randomized, controlled and observational study. The efficacy and safety of Home-based CR (HBCR) in revascularized patients will be evaluated through observation of its clinical characteristics and safety indicators. The study will involve 14 sites nationwide, with an expected sample size of 2,000 followed up for 12 months. The primary endpoints is the incidence of composite major adverse cardiac and cerebrovascular events (MACCE,death from any cause, nonfatal myocardial infarction, revascularization, stroke).Secondary endpoints are defined as decrease of hospitalization due to refractory angina pectoris,the improvements of cardiorespiratory fitness,life quality,as well as angina pectoris.

The subjects will be randomized into 2 different groups, HBCR group and control group. After comprehensive evaluation, the orders from CR staff will be given. Besides the routine health education in both groups, the subjects in HBCR group will be further introduced the instructions of exercise training. The effect of HBCR on cardiorespiratory fitness, improvement of angina, cardiac function, quality of life, levels of anxiety and depression, as well as risk factor profile will also be evaluated. The investigators also aim to explore the factors which influence the adherence of subjects to our HBCR program.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Perspective Randomized Controlled Clinical Trial to Investigate the Effect of Home-based Cardiac Rehabilitation Monitored by Mobile Phone Interaction on Exercise Capacity and One-year Clinical Outcome in Chinese Revascularized Patients
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-based Cardiac Rehabilitation group
remote instructed exercise training at home
Other: home-based cardiac rehabilitation
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).
Other Name: exercise training at home

No Intervention: routine group
no instructed exercise training



Primary Outcome Measures :
  1. MACCE(death, nonfatal myocardial infarction, revascularization, stroke) [ Time Frame: during 12 months ]
    defined as the incidence of composite MACCE.


Secondary Outcome Measures :
  1. improvement of hospitalization due to refractory angina pectoris [ Time Frame: during 12 months ]
    improvement of hospitalization due to refractory angina pectoris which need to be treated in hospital

  2. improvement of cardiorespiratory fitness [ Time Frame: during 12 months ]
    peak oxygen uptake adjusted by body weight measured by cardiopulmonary exercise test

  3. improvement of life quality [ Time Frame: during 12 months ]
    measured by medical outcomes study 36-item short form health survey

  4. improvement of angina pectoris [ Time Frame: during 12 months ]
    measured by Seattle Angina Questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

all of them

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

Exclusion Criteria (Enrollment):

  1. 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.
  2. Hypotensive response to exercise.
  3. acute myocardial infarction within 2 weeks
  4. Poorly controlled hypertension baseline,hyperglycemia,respiratory failure.
  5. severe pulmonary hypertension
  6. acute phase of heart failure
  7. Pathology of musculoskeletal, neurological or breathing that impair the ability of prolonged ambulation.
  8. Pregnant women.
  9. Subjects unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102346


Contacts
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Contact: Jing Ma, MD,PHD 86-10-66935316 crystalma_301@126.com

Locations
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China, Yunnan
the First People's Hospital of Yunnan Province Recruiting
Kunming, Yunnan, China, 650032
Contact: YUNMEI ZHANG, MD    8613888182536    zym888198@sina.com   
Contact: KE ZHUANG, MD    8613888901747    zhuangke@trails1.cn   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Yundai Chen, MD,PHD Director of department of Cardiology, Chinese PLA General Hospital
Publications:

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Responsible Party: Yun Dai Chen, Director, Head of Cardiology, Principal Investigator, Clinical Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03102346    
Other Study ID Numbers: S2016-142-01
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yun Dai Chen, Chinese PLA General Hospital:
cardiorespiratory fitness
coronary artery disease
cardiac rehabilitation
remote control
major adverse cardiac and cerebrovascular events
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases