Coronary Heart DiseaseNCT04923711
Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
A study testing Moderate intensity exercise prescription and High intensity exercise prescription in people with Coronary Heart Disease, run by Jing Ma at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Moderate intensity exercise prescription and High intensity exercise prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years old with a diagnosis of coronary heart disease，NYHA class I-III HF patients.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Perspective Randomized Controlled Study of the Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Moderate intensity exercise prescription, High intensity exercise prescription
- Keywords
- exercise prescription, cardiac rehabilitation, coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity exercise prescriptionBehavioural
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 prescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Group | Experimental | Group received a moderate exercise prescription of moderate intensity Receives: Behavioral: Moderate intensity exercise prescription |
| High Intensity Group | Experimental | Group received a moderate exercise prescription of high intensity Receives: Behavioral: High intensity exercise prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MACE
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
Measured: 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.
Measured: 6 month
Routine color Doppler echocardiography changed.
Routine color Doppler echocardiography changed.
Measured: 6 month
Improvement of Cardiopulmonary exercise test
the improvement of maximum oxygen uptake
Measured: 6 month
Improvement of 6-minute walk test
the improvement of 6 minute walking distance
Measured: 6 month
Improvement of grip strength test
the improvement of grip strength
Measured: 6 month
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Ma, Chinese PLA General Hospital
- Investigators
- Jing Ma, Principal investigator, Department of Cardiology in Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923711
- Sponsor's protocol ID
- 2021-249
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective Randomized Controlled Study of the Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT04923711
- Acronym / sponsor ID
- 2021-249
- Conditions
- Coronary Heart Disease
- Keywords
- exercise prescription, cardiac rehabilitation, coronary heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jing MaUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Group | Experimental | Behavioral: Moderate intensity exercise prescriptionGroup received a moderate exercise prescription of moderate intensity |
| High Intensity Group | Experimental | Behavioral: High intensity exercise prescriptionGroup received a moderate exercise prescription of high intensity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-80 years old with a diagnosis of coronary heart disease，NYHA class I-III HF patients.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity exercise prescriptionExercise 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. | Behavioural | Moderate Intensity Group |
| High intensity exercise prescriptionExercise 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. | Behavioural | High Intensity Group |
Primary outcome
Incidence of MACE
Time frame: 6 month
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
The score of Seattle Angina Questionnaire increased
Time frame: 6 month
The score of Seattle Angina Questionnaire (SAQ, 0-100 each dimension, higher means greater condition）increased.
Routine color Doppler echocardiography changed.
Time frame: 6 month
Routine color Doppler echocardiography changed.
Improvement of Cardiopulmonary exercise test
Time frame: 6 month
the improvement of maximum oxygen uptake
Improvement of 6-minute walk test
Time frame: 6 month
the improvement of 6 minute walking distance
Improvement of grip strength test
Time frame: 6 month
the improvement of grip strength
6 secondary outcomes
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased
Time frame: 6 month
The score of Patient Health Questionnaire decreased
Time frame: 6 month
The score of Generalized Anxiexy Disorde-7 decreased
Time frame: 6 month
The score of Chinese perceived stress scale decreased.
Time frame: 6 month
The score of Pittsburgh Sleep Quality Index Scale decreased.
Time frame: 6 month
The score of Fagerstrom Test for Nicotine Dependence decreased.
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Ma principal investigator
Department of Cardiology in Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity exercise prescription and High intensity exercise prescription in people with Coronary Heart Disease, run by Jing Ma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Ma (+8613681257396, crystalma@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MACE (time frame: 6 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.