Clinical trial NCT04923711: Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
Official title: A Perspective Randomized Controlled Study of the Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: exercise prescription
cardiac rehabilitation
coronary heart disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of MACE
timeFrame: 6 month
measure: The score of Seattle Angina Questionnaire increased
timeFrame: 6 month
measure: Routine color Doppler echocardiography changed.
timeFrame: 6 month
measure: Improvement of Cardiopulmonary exercise test
timeFrame: 6 month
measure: Improvement of 6-minute walk test
timeFrame: 6 month
measure: Improvement of grip strength test
timeFrame: 6 month
Secondary outcomes:
measure: The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased
timeFrame: 6 month
measure: The score of Patient Health Questionnaire decreased
timeFrame: 6 month
measure: The score of Generalized Anxiexy Disorde-7 decreased
timeFrame: 6 month
measure: The score of Chinese perceived stress scale decreased.
timeFrame: 6 month
measure: The score of Pittsburgh Sleep Quality Index Scale decreased.
timeFrame: 6 month
measure: The score of Fagerstrom Test for Nicotine Dependence decreased.
timeFrame: 6 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Department of Cardiology in Chinese PLA General Hospital
name: Jing Ma
role: PRINCIPAL_INVESTIGATOR
References: