Early Mobilization After CABG Surgery (EMAC)

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: Completed
• Conditions: Coronary Artery Disease; Coronary Artery Bypass
• Intervention / Treatment: Behavioral: Structured Early Mobilization Training; Other: Standard Hospital Nursing Care

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Cardiorespiratory Fitness	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)	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)	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 (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)	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)	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	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	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	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	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)	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)	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

• Sponsor: Ta-Chung Chao
• Collaborators: Far Eastern Memorial Hospital; Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Randomized Controlled Trial; Sarcopenia; Postoperative Care; Cardiorespiratory Fitness; Coronary Artery Bypass; Early Mobilization
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coronary Artery Disease; Sarcopenia
• Other Study ID 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