CompletedNot Applicable

Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients

Brazil200 participantsStarted 2024-02-16

Plain-language summary

The goal of this observational and prospective study is to investigate changes in physical performance, lung function, and respiratory and peripheral muscle strength in patients during the postoperative period following coronary artery bypass grafting (CABG) and valve replacement surgery..

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Age ≥ 18 years * Both genders * Elective coronary artery bypass grafting surgery * Elective Heart valve surgery * Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period. Exclusion Criteria: * Surgeries performed via lateral thoracotomy or minithoracotomy * Reoperation for any reason * Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB)

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

To investigate changes in physical performance measured by Six-Minute Walk Test.

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST)

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

To investigate changes in peripheral muscle strength

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

To investigate changes in respiratory muscle strength:

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

Trial details

NCT IDNCT06247358

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-16

View on ClinicalTrials.gov More Cardiac Infarct trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB)

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

To investigate changes in physical performance measured by Six-Minute Walk Test.

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST)

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

To investigate changes in peripheral muscle strength

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.

To investigate changes in respiratory muscle strength:

Timeframe: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.