Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease

Study Overview
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Brief Summary
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The purposes of this study is to standardize the process of formulating exercise prescriptions for coronary heart disease（CHD）, verify the safety and effectiveness of exercise prescriptions, and establish a database of exercise prescriptions for CHD, with a view to providing new solutions for cardiac rehabilitation.

Detailed Description
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This study conducted a comparative study on the therapeutic effect and safety of exercise prescriptions for patients with coronary heart disease with different risk stratifications. The purposes of this study is to standardize the process of formulating exercise prescriptions for coronary heart disease（CHD）, verify the safety and effectiveness of exercise prescriptions, and establish a database of exercise prescriptions for CHD, with a view to providing new solutions for cardiac rehabilitation.

Official Title
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A Perspective Randomized Controlled Study of the Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Moderate intensity exercise prescription
* Behavioral: High intensity exercise prescription


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-80 years old with a diagnosis of coronary heart disease，NYHA class I-III HF patients. Exclusion Criteria: acute myocardial infarction within 2 weeks Uncontrolled tachycardia (heart rate at rest >120bpm Uncontrolled polypnea（breath rate at rest >30 breath per minute Uncontrolled respiratory failure （SPO2 ≤90%） Uncontrolled hyperglycemia (Random blood glucose>18mmol/L) Uncontrolled malignant arrhythmia with hemodynamic instability Uncontrolled septic shock and septicopyemia Uncooperation of the patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Intensity Group<br>Group received a moderate exercise prescription of moderate intensity | Behavioral: Moderate intensity exercise prescription<br>* Exercise Intensity： Low-risk patients: the lower of 60-69% reserve heart rate or the heart rate at the anaerobic threshold. Moderate-risk or high-risk patients: the lower of 50-59% reserve heart rate or the heart rate at the anaerobic threshold.<br>|
| Experimental: High Intensity Group<br>Group received a moderate exercise prescription of high intensity | Behavioral: High intensity exercise prescription<br>* Exercise Intensity： Low-risk patients: the lower of 70-85% reserve heart rate or the heart rate at the anaerobic threshold. Moderate-risk or high-risk patients: the lower of 60-70% reserve heart rate or the heart rate at the anaerobic threshold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MACE | any incidence of the following: death, cardiac death, AMI, revascularization, stroke | 6 month | 
| The score of Seattle Angina Questionnaire increased | The score of Seattle Angina Questionnaire (SAQ, 0-100 each dimension, higher means greater condition）increased. | 6 month | 
| Routine color Doppler echocardiography changed. | Routine color Doppler echocardiography changed. | 6 month | 
| Improvement of Cardiopulmonary exercise test | the improvement of maximum oxygen uptake | 6 month | 
| Improvement of 6-minute walk test | the improvement of 6 minute walking distance | 6 month | 
| Improvement of grip strength test | the improvement of grip strength | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased | The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (abbreviation form is 36-Item Short Form Survey) increased. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability, The sections consists of Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, and Mental health. The total score of SF 36 Health survey is higher, the quality of life is higher. | 6 month | 
| The score of Patient Health Questionnaire decreased | The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased | 6 month | 
| The score of Generalized Anxiexy Disorde-7 decreased | The score of Generalized Anxiexy Disorde-7 (GAD7, normal range 0-21，indicating the profile of anxiety with the higher score) decreased | 6 month | 
| The score of Chinese perceived stress scale decreased. | The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased. | 6 month | 
| The score of Pittsburgh Sleep Quality Index Scale decreased. | The score of Pittsburgh Sleep Quality Index Scale (PSQI, 0-21, higher means poorer sleep quality）decreased. | 6 month | 
| The score of Fagerstrom Test for Nicotine Dependence decreased. | The score of Fagerstrom Test for Nicotine Dependence (FTND, 0-10, higher means more dependence on nicotine）decreased. | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise prescription, cardiac rehabilitation, coronary heart disease