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Completed

NCT Number: NCT07230561

Early Mobilization After CABG Surgery

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atrophy Cardiovascular Diseases Coronary Artery Bypass Coronary Disease Heart Diseases Muscular Atrophy Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Far Eastern Medical Foundation Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Structured Early Mobilization Training

Behavioral

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.

Standard Hospital Nursing Care

Other

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.

Primary outcomes

  1. 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.

  2. 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".

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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).

  12. 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).

Sponsors and collaborators

Lead sponsor

Ta-Chung Chao

Other

Collaborators

  • Far Eastern Memorial Hospital
  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

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

Acronym: EMAC

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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