Back to resultsFormulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Moderate intensity exercise prescription
High intensity exercise prescription
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring exercise prescription, cardiac rehabilitation, coronary heart disease
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
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Moderate Intensity Group
High Intensity Group
Arm Description
Group received a moderate exercise prescription of moderate intensity
Group received a moderate exercise prescription of high intensity
Outcomes
Primary Outcome Measures
Incidence of MACE
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
The score of Seattle Angina Questionnaire increased
The score of Seattle Angina Questionnaire (SAQ, 0-100 each dimension, higher means greater condition）increased.
Routine color Doppler echocardiography changed.
Routine color Doppler echocardiography changed.
Improvement of Cardiopulmonary exercise test
the improvement of maximum oxygen uptake
Improvement of 6-minute walk test
the improvement of 6 minute walking distance
Improvement of grip strength test
the improvement of grip strength
Secondary Outcome Measures
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.
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
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
The score of Chinese perceived stress scale decreased.
The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04923711
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing Ma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
exercise prescription, cardiac rehabilitation, coronary heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderate Intensity Group
Arm Type
Experimental
Arm Description
Group received a moderate exercise prescription of moderate intensity
Arm Title
High Intensity Group
Arm Type
Experimental
Arm Description
Group received a moderate exercise prescription of high intensity
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity exercise prescription
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High intensity exercise prescription
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of MACE
Description
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
Time Frame
6 month
Title
The score of Seattle Angina Questionnaire increased
Description
The score of Seattle Angina Questionnaire (SAQ, 0-100 each dimension, higher means greater condition）increased.
Time Frame
6 month
Title
Routine color Doppler echocardiography changed.
Description
Routine color Doppler echocardiography changed.
Time Frame
6 month
Title
Improvement of Cardiopulmonary exercise test
Description
the improvement of maximum oxygen uptake
Time Frame
6 month
Title
Improvement of 6-minute walk test
Description
the improvement of 6 minute walking distance
Time Frame
6 month
Title
Improvement of grip strength test
Description
the improvement of grip strength
Time Frame
6 month
Secondary Outcome Measure Information:
Title
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased
Description
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.
Time Frame
6 month
Title
The score of Patient Health Questionnaire decreased
Description
The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased
Time Frame
6 month
Title
The score of Generalized Anxiexy Disorde-7 decreased
Description
The score of Generalized Anxiexy Disorde-7 (GAD7, normal range 0-21，indicating the profile of anxiety with the higher score) decreased
Time Frame
6 month
Title
The score of Chinese perceived stress scale decreased.
Description
The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
Time Frame
6 month
Title
The score of Pittsburgh Sleep Quality Index Scale decreased.
Description
The score of Pittsburgh Sleep Quality Index Scale (PSQI, 0-21, higher means poorer sleep quality）decreased.
Time Frame
6 month
Title
The score of Fagerstrom Test for Nicotine Dependence decreased.
Description
The score of Fagerstrom Test for Nicotine Dependence (FTND, 0-10, higher means more dependence on nicotine）decreased.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Ma
Phone
+8613681257396
Email
crystalma@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ma
Organizational Affiliation
Department of Cardiology in Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Ma
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
The IPD of the publication will be shared, including characteristic data, results, clinical follow up data.
Learn more about this trial
Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
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