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

June 7, 2021 updated by: Jing Ma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of MACE
Time Frame: 6 month
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
6 month
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.
6 month
Routine color Doppler echocardiography changed.
Time Frame: 6 month
Routine color Doppler echocardiography changed.
6 month
Improvement of Cardiopulmonary exercise test
Time Frame: 6 month
the improvement of maximum oxygen uptake
6 month
Improvement of 6-minute walk test
Time Frame: 6 month
the improvement of 6 minute walking distance
6 month
Improvement of grip strength test
Time Frame: 6 month
the improvement of grip strength
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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.
6 month
The score of Chinese perceived stress scale decreased.
Time Frame: 6 month
The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
6 month
The score of Patient Health Questionnaire decreased
Time Frame: 6 month
The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased
6 month
The score of Generalized Anxiexy Disorde-7 decreased
Time Frame: 6 month
The score of Generalized Anxiexy Disorde-7 (GAD7, normal range 0-21，indicating the profile of anxiety with the higher score) decreased
6 month
The score of Pittsburgh Sleep Quality Index Scale decreased.
Time Frame: 6 month
The score of Pittsburgh Sleep Quality Index Scale (PSQI, 0-21, higher means poorer sleep quality）decreased.
6 month
The score of Fagerstrom Test for Nicotine Dependence decreased.
Time Frame: 6 month
The score of Fagerstrom Test for Nicotine Dependence (FTND, 0-10, higher means more dependence on nicotine）decreased.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing Ma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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