Early Mobilization After CABG Surgery (EMAC)

November 16, 2025 updated by: Ta-Chung Chao

The Efficacy of Structured Early Mobilization Training in Patients After Coronary Artery Bypass Surgery: A Randomized Controlled Trial

The goal of this clinical trial is to learn if a structured early exercise program can help patients recover better in people who have just had coronary artery bypass surgery. The main questions it aims to answer are:

  • Does this early exercise improve fitness and walking ability?
  • Does it reduce the risk of muscle weakness (sarcopenia) after surgery?
  • Does it improve patients' quality of life?
  • Does it reduce feelings of anxiety and depression? Researchers will compare the group receiving the structured early exercise program (plus standard hospital care) to the group receiving standard hospital care only to see if the early exercise program leads to better and faster recovery.

Participants in the exercise group will:

  • Start supervised exercise sessions within 24 hours after their surgery.
  • Perform these sessions twice a day for 30 minutes each, for 5 days.
  • The exercises include warm-ups, breathing exercises, walking or stationary cycling, and light resistance training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Medical Foundation Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age between 40 and 85 years;
  • undergoing first-time CABG surgery;
  • no diagnosed psychiatric disorders or musculoskeletal diseases and did not require any assistive mobility devices;
  • ability to communicate in Mandarin or Taiwanese;
  • agreed to participate and provided written informed consent after receiving a comprehensive explanation of this trial.

Exclusion Criteria:

  • preoperative use of continuous 24-hour nitroglycerin infusion or inotropic agents;
  • undergoing emergency cardiac surgery or requiring admission to the intensive care unit preoperatively;
  • occurrence of major intraoperative complications (e.g., major hemorrhage, stroke, requirement for resuscitation, or severe delirium).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Group
Participants received standard hospital nursing care PLUS supervised, structured early mobilization training. The protocol was developed by integrating Phase 1 cardiac rehabilitation guidelines with an expert consensus approach from a multidisciplinary team. The intervention began within 24 hours postoperatively, was conducted for 5 days, twice daily, 30 min/session. Sessions included a 5-min warm-up (active/passive ROM), a 20-min main training (FITT principle: Intensity at resting heart rate + 20 bpm, max 120 bpm; Type: inspiratory muscle training, ROM, stationary cycling or bedside ambulation, resistance training), and a 5-min cool-down.
Behavioral: Structured Early Mobilization Training
The training protocol was developed by integrating Phase 1 cardiac rehabilitation guidelines with an expert consensus approach from a multidisciplinary team. The intervention began within 24 hours postoperatively, was conducted for 5 days, twice daily, 30 min/session. Sessions included a 5-min warm-up (active/passive ROM), a 20-min main training (FITT principle: Intensity at resting heart rate + 20 bpm, max 120 bpm; Type: inspiratory muscle training, ROM, stationary cycling or bedside ambulation, resistance training), and a 5-min cool-down.
Other: Standard Hospital Nursing Care
The standard hospital nursing care included physiological monitoring, medication counseling, psychological support, disease-specific health education, instruction on the use of an incentive spirometer, and education on the importance and methods of rehabilitation.
Active Comparator: Comparison Group
Participants received standard hospital nursing care only. This included physiological monitoring, medication counseling, psychological support, disease-specific health education, instruction on the use of an incentive spirometer, and education on the importance and methods of rehabilitation.
Other: Standard Hospital Nursing Care
The standard hospital nursing care included physiological monitoring, medication counseling, psychological support, disease-specific health education, instruction on the use of an incentive spirometer, and education on the importance and methods of rehabilitation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Cardiorespiratory Fitness
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed by the 6-minute walk test (6MWT). Total distance (in meters) walked along a 30-meter flat corridor in six minutes.
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Muscle Strength (Left Handgrip)
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed by maximal handgrip strength (in kg) using a hydraulic dynamometer.
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Muscle Strength (Right Handgrip)
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed by maximal handgrip strength (in kg) using a hydraulic dynamometer.
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Physical Performance (5-Times Sit-to-Stand Test)
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Time (in seconds) taken to stand and sit five times from a chair with arms crossed.
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Muscle Mass Proxy (Left Calf Circumference)
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Maximum circumference (in cm) at the widest part of the calf while seated.
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Muscle Mass Proxy (Right Calf Circumference)
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Maximum circumference (in cm) at the widest part of the calf while seated.
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Sarcopenia Risk Classification
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed using the Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire. The total score ranges from 0 to 10. Higher scores indicate a greater risk of sarcopenia (worse outcome). Classified as "at risk" (SARC-F total score more than or equal to 4 points) or "not at risk".
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) Total Score
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed using the Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire. The total score ranges from 0 to 10. Higher scores indicate a greater risk of sarcopenia (worse outcome).
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Quality of Life
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire. The index score typically ranges from 0 to 1.00. Higher scores indicate a better quality of life (better outcome), with 1.00 representing perfect health and 0 representing death.
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Self-Rated Health
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed using the EuroQol visual analogue scale (EQ-VAS). Scale 0 (worst imaginable) to 100 (best imaginable).
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Mood (Anxiety)
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed using the Hospital Anxiety and Depression Scale (HADS) Anxiety subscale. Score ranges from 0 to 21. Higher scores indicate higher levels of anxiety (worse outcome).
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Change in Mood (Depression)
Time Frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed using the Hospital Anxiety and Depression Scale (HADS) Depression subscale. Score ranges from 0 to 21. Higher scores indicate higher levels of depression (worse outcome).
Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ta-Chung Chao

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Far Eastern Memorial Hospital
Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 113105-F
  • FEMH-2024-C-094 (Other Grant/Funding Number: Far Eastern Medical Foundation Far Eastern Memorial Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in the final publication will be made available. The study protocol will also be available.

IPD Sharing Time Frame

Data will be available beginning 6 months after the publication of the primary manuscript and will remain available for 5 years.

IPD Sharing Access Criteria

Data access will be granted to qualified academic researchers for legitimate research purposes, such as re-analysis or meta-analysis. Researchers must submit a methodologically sound proposal to the corresponding author. Upon approval by the principal investigators and the Institutional Review Board, and contingent upon the terms of the original informed consent, de-identified Individual Participant Data that underlie the results reported in the final publication (including main dataset and analytic code) will be shared. A signed data-use agreement will be required prior to data release to ensure participant confidentiality.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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