The Research Aims to Study the Effectiveness of a Physical Exercise Program on Indicators of Quality of Life and Functionality: It Will be Applied at Home to People Undergoing Cardiac Surgery, in Phase II of Cardiac Rehabilitation

NCT ID: NCT07153874

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to test the effectiveness of an physical exercise intervention in people after cardiac surgery, namely valve replacement and coronary artery bypass graft. The main question\[s\] it aims to answer are: • what is the influence of a physical exercise program on quality of life in people after cardiac surgery • what is the influence of a physical exercise program on functional status in people after cardiac surgery. Participants will be allocated to exepriemtal group and perform a physical exercise program during 12 weeks and the program is composed by aerobic and anaerobic exercise. They will be evaluated at the beginning, middle and in the end of the program. Researchers will compare the experimental and the control group to see the effects in quality of life and functional status.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery Rehabilitation Program Quality of Life Functional Status

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Group that will complete the structured and monitored physical exercise program.

Group Type EXPERIMENTAL

Physical exercise rehabilitation intervention

Intervention Type OTHER

12 weeks of physical exercise intervention, including aerobic snd anaerobic exercise at home. 36 sessions of monitorized training with distance supervision.

Control

Group that receives no intervention during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical exercise rehabilitation intervention

12 weeks of physical exercise intervention, including aerobic snd anaerobic exercise at home. 36 sessions of monitorized training with distance supervision.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HeartBackToBeat

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clients undergoing cardiac surgery for the first time: heart valve surgery, coronary artery bypass grafting, after discharge from hospital in a home setting;
* Clients at low and moderate risk of cardiovascular events;
* Clients over the age of 18;
* Clients who are part of the localities assisted by the hospital unit;
* Clients with preserved cognitive capacity.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Católica Portuguesa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pedro José Moreira Barbosa

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Hospitalar Universitário de São João

Porto, Porto District, Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

References

Explore related publications, articles, or registry entries linked to this study.

American College of Sports and Medicine. (2021). Guidelines for Exercise Testing and Prescription (W. Kluwer Ed. 11 ed.). Philadelphia

Reference Type BACKGROUND

Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP; Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):1-17. doi: 10.1097/HJR.0b013e3283313592.

Reference Type BACKGROUND
PMID: 19952757 (View on PubMed)

Rossello X, Dorresteijn JA, Janssen A, Lambrinou E, Scherrenberg M, Bonnefoy-Cudraz E, Cobain M, Piepoli MF, Visseren FL, Dendale P, This Paper Is A Co-Publication Between European Journal Of Preventive Cardiology European Heart Journal Acute Cardiovascular Care And European Journal Of Cardiovascular Nursing. Risk prediction tools in cardiovascular disease prevention: A report from the ESC Prevention of CVD Programme led by the European Association of Preventive Cardiology (EAPC) in collaboration with the Acute Cardiovascular Care Association (ACCA) and the Association of Cardiovascular Nursing and Allied Professions (ACNAP). Eur J Prev Cardiol. 2019 Sep;26(14):1534-1544. doi: 10.1177/2047487319846715. Epub 2019 Jun 24.

Reference Type BACKGROUND
PMID: 31234648 (View on PubMed)

Supervia M, Medina-Inojosa J, Martinez-Jarreta B, Lopez-Jimenez F, Vickers K, Terzic CM, Thomas RJ. Cardiac Rehabilitation Completion Study: Barriers and Potential Solutions. J Cardiopulm Rehabil Prev. 2022 Sep 1;42(5):375-377. doi: 10.1097/HCR.0000000000000709. No abstract available.

Reference Type BACKGROUND
PMID: 36044761 (View on PubMed)

Thomas RJ, King M, Lui K, Oldridge N, Pina IL, Spertus J; American Association of Cardiovascular and Pulmonary Rehabilitation/American College of Cardiology/American Heart Association Cardiac Rehabilitation/Secondary Prevention Performance Measures Writing Committee. AACVPR/ACC/AHA 2007 performance measures on cardiac rehabilitation for referral to and delivery of cardiac rehabilitation/secondary prevention services. Circulation. 2007 Oct 2;116(14):1611-42. doi: 10.1161/CIRCULATIONAHA.107.185734. Epub 2007 Sep 20. No abstract available.

Reference Type BACKGROUND
PMID: 17885210 (View on PubMed)

Thomas RJ, Balady G, Banka G, Beckie TM, Chiu J, Gokak S, Ho PM, Keteyian SJ, King M, Lui K, Pack Q, Sanderson BK, Wang TY. 2018 ACC/AHA Clinical Performance and Quality Measures for Cardiac Rehabilitation: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2018 Apr 24;71(16):1814-1837. doi: 10.1016/j.jacc.2018.01.004. Epub 2018 Mar 29. No abstract available.

Reference Type BACKGROUND
PMID: 29606402 (View on PubMed)

Vidal-Almela S, Czajkowski B, Prince SA, Chirico D, Way KL, Pipe AL, Reed JL. Lessons learned from community- and home-based physical activity programs: A narrative review of factors influencing women's participation in cardiac rehabilitation. Eur J Prev Cardiol. 2021 Jul 10;28(7):761-778. doi: 10.1177/2047487320907748.

Reference Type BACKGROUND
PMID: 33611528 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

115/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.