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Cardiac SurgeryHeartBack2BeatNCT07153874

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

A study testing Physical exercise rehabilitation intervention in people with Cardiac Surgery and Rehabilitation Program, run by Universidade Católica Portuguesa at 1 site in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Physical exercise rehabilitation intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 sitePortugal
Study dates
19 Feb 2024to 31 Aug 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Centro Hospitalar Universitário de São João

    Porto, Porto District, 4200-319

Other trials in Portugal

About this study

Official title: The Effectiveness of a Physical Exercise Program in the Person Undergoing Cardiac Surgery

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.

Being tested
Physical exercise rehabilitation intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exercise rehabilitation interventionOther

    Also called HeartBackToBeat

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

Study groups in NCT07153874
Study groupRoleWhat they receive
ExperimentalExperimentalGroup that will complete the structured and monitored physical exercise program.
Receives: Other: Physical exercise rehabilitation intervention
ControlNo interventionGroup that receives no intervention during the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functionality

    Functionality is the ability regarding basic physical and cognitive activities such as walking or reaching, focusing attention, and communicating, as well as the routine activities of daily living, including eating, bathing, dressing, transferring, and toileting; and life situations such as school or play for children and, for adults, work outside the home or maintaining a household. It will be measured by the London Chest Daily Activities scale.

    Measured: The results are expected to be measured at the beginning of the program, at six weeks, and at the end (at 12 weeks).

  2. Perceived Quality of life

    Quality of life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. It will be measured by the Short Form-36 quality of life assessment scale.

    Measured: The results are expected to be measured at the beginning of the program, at six weeks, and at the end (at 12 weeks).

  3. Tolerance to physical exercise

    Tolerance to physical exercise is the exercise capacity of an individual as measured by endurance (maximal exercise duration and/or maximal attained work load) during an exercise test. It will be measured by the 6-minute walk test.

    Measured: The results are expected to be measured at the beginning of the program, at six weeks, and at the end (at 12 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start19 Feb 2024
  3. Primary completion10 Jun 2024
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07153874
Sponsor's protocol ID
115/2023
Acronym
HeartBack2Beat
Status last verified
Aug 2025
First submitted
18 Aug 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36044761

  • 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.

    PubMed 33611528

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

  • 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.

    PubMed 19952757

  • 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.

    PubMed 31234648

  • 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.

    PubMed 17885210

  • 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.

    PubMed 29606402

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise rehabilitation intervention in people with Cardiac Surgery and Rehabilitation Program, run by Universidade Católica Portuguesa at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functionality (time frame: The results are expected to be measured at the beginning of the program, at six weeks, and at the end (at 12 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07153874, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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HeartBack2Beat Clinical Trial NCT07153874 | AzTrials