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

Not Applicable

• Conditions: Coronary Heart Disease
• Interventions: Behavioral: High intensity exercise prescription; Behavioral: Moderate intensity exercise prescription

• Registration Number: NCT04923711
• Lead Sponsor: Jing Ma

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.

Study Timeline

• Study First Submitted: 2021-05-31
• Status Verified: 2021-06
• Study Start: 2021-06-01
• Study First Submitted QC: 2021-06-07
• Last Update Submitted: 2021-06-07
• Study First Posted: 2021-06-11
• Last Update Posted: 2021-06-11
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Group	High intensity exercise prescription	Group received a moderate exercise prescription of high intensity
Moderate Intensity Group	Moderate intensity exercise prescription	Group received a moderate exercise prescription of moderate intensity

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The score of Patient Health Questionnaire decreased	6 month	The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased
The score of Generalized Anxiexy Disorde-7 decreased	6 month	The score of Generalized Anxiexy Disorde-7 (GAD7, normal range 0-21，indicating the profile of anxiety with the higher score) decreased
The score of Pittsburgh Sleep Quality Index Scale decreased.	6 month	The score of Pittsburgh Sleep Quality Index Scale (PSQI, 0-21, higher means poorer sleep quality）decreased.
The score of Fagerstrom Test for Nicotine Dependence decreased.	6 month	The score of Fagerstrom Test for Nicotine Dependence (FTND, 0-10, higher means more dependence on nicotine）decreased.
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased	6 month	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.
The score of Chinese perceived stress scale decreased.	6 month	The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China