CClinicalTrials.gg
Status unknownNCT04923711Updated Jun 11, 2021

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

An interventional study of Moderate intensity exercise prescription and High intensity exercise prescription in Coronary Heart Disease, sponsored by Jing Ma. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-11.

Sponsored by Jing Ma · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Heart Disease

Keywords

  • exercise prescription
  • cardiac rehabilitation
  • coronary heart disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Jing Ma is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Moderate Intensity Group

    Group received a moderate exercise prescription of moderate intensity

    Behavioral: Moderate intensity exercise prescription

  • Experimental
    High Intensity Group

    Group received a moderate exercise prescription of high intensity

    Behavioral: High intensity exercise prescription

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.

06

What researchers measure

Primary outcomes

  1. Incidence of MACE

    any incidence of the following: death, cardiac death, AMI, revascularization, stroke

    Time frame: 6 month

  2. The score of Seattle Angina Questionnaire increased

    The score of Seattle Angina Questionnaire (SAQ, 0-100 each dimension, higher means greater condition)increased.

    Time frame: 6 month

  3. Routine color Doppler echocardiography changed.

    Routine color Doppler echocardiography changed.

    Time frame: 6 month

  4. Improvement of Cardiopulmonary exercise test

    the improvement of maximum oxygen uptake

    Time frame: 6 month

  5. Improvement of 6-minute walk test

    the improvement of 6 minute walking distance

    Time frame: 6 month

  6. Improvement of grip strength test

    the improvement of grip strength

    Time frame: 6 month

Secondary outcomes

  1. 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.

    Time frame: 6 month

  2. 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

    Time frame: 6 month

  3. 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

    Time frame: 6 month

  4. The score of Chinese perceived stress scale decreased.

    The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.

    Time frame: 6 month

  5. 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.

    Time frame: 6 month

  6. 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.

    Time frame: 6 month

07

Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, China
    • Jing Ma · Contact
08

References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04923711
Lead sponsor
Jing Ma
Responsible party
Jing Ma (Clincial professor, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Jun 11, 2021
Start date
Jun 1, 2021 (estimated)
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Jun 11, 2021

Study contacts

Jing Ma
Contact
crystalma@126.com
+8613681257396
Jing Ma
principal investigator · Department of Cardiology in Chinese PLA General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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