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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04923711
Enrollment
200
Registered
2021-06-11
Start date
2021-06-01
Completion date
2023-06-30
Last updated
2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

exercise prescription, cardiac rehabilitation, coronary heart disease

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.

Interventions

BEHAVIORALModerate 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.

BEHAVIORALHigh 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.

Sponsors

Jing Ma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of grip strength test6 monththe improvement of grip strength
Incidence of MACE6 monthany incidence of the following: death, cardiac death, AMI, revascularization, stroke
The score of Seattle Angina Questionnaire increased6 monthThe score of Seattle Angina Questionnaire (SAQ, 0-100 each dimension, higher means greater condition)increased.
Routine color Doppler echocardiography changed.6 monthRoutine color Doppler echocardiography changed.
Improvement of Cardiopulmonary exercise test6 monththe improvement of maximum oxygen uptake
Improvement of 6-minute walk test6 monththe improvement of 6 minute walking distance

Secondary

MeasureTime frameDescription
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased6 monthThe 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 decreased6 monthThe 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 decreased6 monthThe 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.6 monthThe score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
The score of Pittsburgh Sleep Quality Index Scale decreased.6 monthThe 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 monthThe score of Fagerstrom Test for Nicotine Dependence (FTND, 0-10, higher means more dependence on nicotine)decreased.

Countries

China

Contacts

Primary ContactJing Ma
crystalma@126.com+8613681257396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026