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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04923711
• Other study ID #: 2021-249
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2021
• Source: Chinese PLA General Hospital
• Contact: Jing Ma
• Phone: +8613681257396
• Email: crystalma[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Moderate intensity exercise prescription
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.
• High intensity exercise prescription
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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jing Ma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MACE	any incidence of the following: death, cardiac death, AMI, revascularization, stroke	6 month
Primary	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
Primary	Routine color Doppler echocardiography changed.	Routine color Doppler echocardiography changed.	6 month
Primary	Improvement of Cardiopulmonary exercise test	the improvement of maximum oxygen uptake	6 month
Primary	Improvement of 6-minute walk test	the improvement of 6 minute walking distance	6 month
Primary	Improvement of grip strength test	the improvement of grip strength	6 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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