NCT06247358

Brief 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..

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Feb 2024Oct 2026

First Submitted

Initial submission to the registry

December 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

February 16, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2026

Expected
Last Updated

March 28, 2025

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

December 19, 2023

Last Update Submit

March 24, 2025

Conditions

Cardiac InfarctCardiac Valve DiseaseFragilityPhysical Disability

Keywords

Cardiac surgeryShort Physical Performance Battery1-minute sit-tostand testSpirometrymuscular strength

Outcome Measures

Primary Outcomes (7)

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

    Measures: walking speed, standing balance and sit-to-stand performance.

    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.

    Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.

    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)

    Measure: number of 1-MSTST repetitions.

    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

    Measure: hand grip strengh measure (Kgf)

    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:

    Measures: maximal inspiratory and expiratory pressure (cmH2O)

    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 lung function test measure by spirometry:

    Measures: FVC (L), FEV1 (L), FEF (L/s) and FEF 25-75 (%)

    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 frailty by Clinical Frailty Scale (CFS)

    The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.

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

Secondary Outcomes (5)

  • To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.

    Baseline (one day before the surgery) during the immediate postoperative period.

  • To investigate hemodynamic behavior during the Short Physical Performance Battery (SPPB).

    Immediately before and after the SPPB.

  • To investigate hemodynamic behavior during the 1-minute sit-to-stand test (1-MSTST).

    Immediately before and after the 1-MSTST tests.

  • To investigate respiratory behavior during the Short Physical Performance Battery (SPPB).

    Immediately before and after the SPPB.

  • To investigate respiratory behavior during 1-minute sit-to-stand test (1-1-MSTST).

    Immediately before and after the 1-MSTST tests.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in the preoperative period of elective coronary artery bypass grafting and valve replacement surgery

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionHeart Valve Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Rafael M Ianotti, PT

    Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael M Ianotti, PT

CONTACT

+55 11 26615319rafael.ianotti@hc.fm.usp.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)

Study Record Dates

First Submitted

December 19, 2023

First Posted

February 7, 2024

Study Start

February 16, 2024

Primary Completion

September 10, 2025

Study Completion (Estimated)

October 10, 2026

Last Updated

March 28, 2025

Record last verified: 2024-03

Locations

BR(1)