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

Sponsor
Jing Ma (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04923711
Collaborator
(none)
200
1
2
24.9
8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Moderate intensity exercise prescription
  • Behavioral: High intensity exercise prescription
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Perspective Randomized Controlled Study of the Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Moderate Intensity Group

Group received a moderate exercise prescription of moderate intensity

Behavioral: Moderate 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.

Experimental: High Intensity Group

Group received a moderate exercise prescription of high intensity

Behavioral: High 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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of MACE [6 month]

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

  2. 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.

  3. Routine color Doppler echocardiography changed. [6 month]

    Routine color Doppler echocardiography changed.

  4. Improvement of Cardiopulmonary exercise test [6 month]

    the improvement of maximum oxygen uptake

  5. Improvement of 6-minute walk test [6 month]

    the improvement of 6 minute walking distance

  6. Improvement of grip strength test [6 month]

    the improvement of grip strength

Secondary Outcome Measures

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese PLA General Hospital Beijing China

Sponsors and Collaborators

  • Jing Ma

Investigators

  • Principal Investigator: Jing Ma, Department of Cardiology in Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jing Ma, Clincial professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT04923711
Other Study ID Numbers:
  • 2021-249
First Posted:
Jun 11, 2021
Last Update Posted:
Jun 11, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jing Ma, Clincial professor, Chinese PLA General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 11, 2021