NCT07730034

Brief Summary

This study aims to determine whether starting respiratory physiotherapy one hour after removal of the breathing tube following elective coronary artery bypass graft (CABG) surgery leads to better recovery than the current standard approach, in which physiotherapy begins on the first postoperative day. The study will evaluate whether earlier physiotherapy improves lung function, reduces postoperative pulmonary complications, shortens intensive care unit and hospital stay, decreases pain and anxiety, and improves overall recovery after surgery. The main question is whether very early postoperative respiratory physiotherapy provides additional benefits for patients recovering from elective heart surgery compared with standard postoperative care.

Trial Health

63
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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

July 3, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 3, 2026

Last Update Submit

July 24, 2026

Conditions

CABGRespiratory InsufficiencyPostoperative Pulmonary Complications (PPCs)

Keywords

Coronary artery bypass grafting (CABG)Early postoperative physiotherapyRespiratory physiotherapyCardiac surgeryPulmonary rehabilitationRespiratory insufficiency

Outcome Measures

Primary Outcomes (1)

  • Change in Forced Expiratory Volume in One Second (FEV1)

    Change in FEV1 measured by portable spirometry to evaluate postoperative pulmonary function after coronary artery bypass graft surgery.

    From baseline (preoperative) until hospital discharge (approximately up to 21 days after surgery)

Secondary Outcomes (11)

  • Change in Peak Expiratory Flow (PEF)

    Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).

  • Postoperative pulmonary complications

    From surgery until hospital discharge (approximately up to 21 days after surgery).

  • Change in Forced Expiratory Volume (FEV)

    Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).

  • Length of intensive care unit (ICU) stay

    From ICU admission until ICU discharge (approximately up to 21 days after surgery).

  • Pain intensity

    Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).

  • +6 more secondary outcomes

Study Arms (2)

Early postoperative physiotherapy

EXPERIMENTAL

Participants receive a standardized early postoperative physiotherapy program initiated within the first postoperative hours according to the study protocol, in addition to standard perioperative management.

Procedure: Early postoperative physiotherapy

Standard postoperative care

ACTIVE COMPARATOR

Participants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice.

Procedure: Standard postoperative care

Interventions

Early postoperative physiotherapyPROCEDURE

Participants receive an early postoperative physiotherapy protocol initiated within the first 24 hours after elective cardiac surgery. The intervention includes breathing exercises, airway clearance techniques, early mobilization, progressive ambulation, and individualized therapeutic exercises according to a standardized protocol in addition to standard postoperative care.

Early postoperative physiotherapy
Standard postoperative carePROCEDURE

Participants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice without the structured early physiotherapy protocol.

Standard postoperative care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-80 years
  • Male and female participants
  • Elective coronary artery bypass grafting (CABG)
  • Body mass index (BMI) \< 30 kg/m²
  • Left ventricular ejection fraction (EF) \> 25%
  • Extubated on postoperative day 0 (POD 0)
  • Able and willing to provide written informed consent
  • Able to perform spirometry and follow study instructions

You may not qualify if:

  • Refusal or inability to provide informed consent
  • Emergency CABG surgery
  • Previous cardiac surgery
  • Severe cardiac arrhythmias (e.g., ventricular tachycardia/fibrillation, third-degree atrioventricular block)
  • Previous stroke
  • Motor impairment of upper or lower extremities due to neurological or musculoskeletal disease
  • Dyskinesia
  • Not extubated on POD 0
  • Significant postoperative neurological complications
  • Peripheral arterial disease of the lower extremities or previous lower-limb amputation
  • Acute or chronic pulmonary disease
  • Preoperative FEV1 \<30% of predicted (greater than 70% reduction)
  • Inability to perform spirometry correctly
  • Cancelled surgery after preoperative assessment
  • Extubation later than 24 hours after surgery
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Dijana Filipović, MSc

    Clinical Hospital Centre Zagreb

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dijana Filipović, MSc

CONTACT

+385 99 4663124dijana.filipovic@kbc-zagreb.hr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to one of two parallel study arms: an experimental group receiving the postoperative physiotherapy protocol and a control group receiving standard postoperative physiotherapy care.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 28, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because participant confidentiality will be protected in accordance with the study protocol and ethics committee requirements.

Locations

CR(1)