NCT05320848

Brief Summary

Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. Current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. Its use in these conditions is supported by a robust body of research demonstrating improved clinical outcomes. Despite this evidence, cardiac rehabilitation referral and attendance remains low and interventions to increase its use need to be developed.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 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

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

August 4, 2021

Last Update Submit

April 8, 2022

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • first occurrence of major adverse cardiovascular events (MACE)

    first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization)

    3 years

  • maximum oxygen uptake

    maximum oxygen uptake

    3 years

Study Arms (2)

Treatment group

EXPERIMENTAL

the patients treated with cardiac rehabilitation intervention.

Behavioral: cardiac rehabilitation

Control group

NO INTERVENTION

the patients treated without cardiac rehabilitation intervention.

Interventions

cardiac rehabilitationBEHAVIORAL

Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease.

Treatment group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiovascular disease

You may not qualify if:

  • Incalculable TFC
  • Coronary artery spasm or ectasia
  • LV ejection fraction \< 52% in males or \< 54% in females
  • Abnormal heart structure (congenital heart disease, cardiomyopathies, or valvular dysfunction)
  • Pericardial disease (pericardial effusion or constrictive pericarditis)
  • Previous history of myocardial infarction
  • Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 105 mmHg)
  • Hyperthyroidism
  • Hypothyroidism
  • Malignancy
  • Autoimmune disease
  • Infection
  • Pulmonary, hepatic, and renal disorders
  • Haematological disorders (anaemia, bone marrow involved by neoplastic disease, or red blood cell transfusions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, China

Location

Related Publications (5)

  • Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.

    PMID: 26730878BACKGROUND

  • Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.

    PMID: 27557484BACKGROUND

  • Wong WP, Feng J, Pwee KH, Lim J. A systematic review of economic evaluations of cardiac rehabilitation. BMC Health Serv Res. 2012 Aug 8;12:243. doi: 10.1186/1472-6963-12-243.

    PMID: 22873828BACKGROUND

  • Ragupathi L, Stribling J, Yakunina Y, Fuster V, McLaughlin MA, Vedanthan R. Availability, Use, and Barriers to Cardiac Rehabilitation in LMIC. Glob Heart. 2017 Dec;12(4):323-334.e10. doi: 10.1016/j.gheart.2016.09.004. Epub 2017 Mar 13.

    PMID: 28302548BACKGROUND

  • Edwards K, Jones N, Newton J, Foster C, Judge A, Jackson K, Arden NK, Pinedo-Villanueva R. The cost-effectiveness of exercise-based cardiac rehabilitation: a systematic review of the characteristics and methodological quality of published literature. Health Econ Rev. 2017 Oct 19;7(1):37. doi: 10.1186/s13561-017-0173-3.

    PMID: 29052044BACKGROUND

MeSH Terms

Interventions

Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

April 11, 2022

Study Start

February 1, 2021

Primary Completion

May 1, 2022

Study Completion

February 1, 2025

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)