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NCT Number: NCT07153874

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Universitário de São João

Porto, Porto District, 4200-319, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Physical exercise rehabilitation intervention

Other

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

Other names: HeartBackToBeat

Primary outcomes

  1. 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).

    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.

  2. Perceived Quality of life

    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).

    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.

  3. Tolerance to physical exercise

    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).

    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.

Sponsors and collaborators

Lead sponsor

Universidade Católica Portuguesa

Other

Registry information

Official study title

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

Acronym: HeartBack2Beat

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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