NCT04923711

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

May 31, 2021

Last Update Submit

June 7, 2021

Conditions

Coronary Heart Disease

Keywords

exercise prescriptioncardiac rehabilitationcoronary heart disease

Outcome Measures

Primary Outcomes (6)

  • Incidence of MACE

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

    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.

    6 month

  • Routine color Doppler echocardiography changed.

    Routine color Doppler echocardiography changed.

    6 month

  • Improvement of Cardiopulmonary exercise test

    the improvement of maximum oxygen uptake

    6 month

  • Improvement of 6-minute walk test

    the improvement of 6 minute walking distance

    6 month

  • Improvement of grip strength test

    the improvement of grip strength

    6 month

Secondary Outcomes (6)

  • The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased

    6 month

  • The score of Patient Health Questionnaire decreased

    6 month

  • The score of Generalized Anxiexy Disorde-7 decreased

    6 month

  • The score of Chinese perceived stress scale decreased.

    6 month

  • The score of Pittsburgh Sleep Quality Index Scale decreased.

    6 month

  • +1 more secondary outcomes

Study Arms (2)

Moderate Intensity Group

EXPERIMENTAL

Group received a moderate exercise prescription of moderate intensity

Behavioral: Moderate intensity exercise prescription

High Intensity Group

EXPERIMENTAL

Group received a moderate exercise prescription of high intensity

Behavioral: High intensity exercise prescription

Interventions

Moderate intensity exercise prescriptionBEHAVIORAL

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.

Moderate Intensity Group
High intensity exercise prescriptionBEHAVIORAL

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.

High Intensity Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 years old with a diagnosis of coronary heart disease，NYHA class I-III HF patients.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jing Ma

    Department of Cardiology in Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ma

CONTACT

+8613681257396crystalma@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clincial professor

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 11, 2021

Study Start

June 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

June 11, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
starting 6 months after publication
Access Criteria
The IPD of the publication will be shared, including characteristic data, results, clinical follow up data.

Locations

CN(1)