Early Mobilization After CABG Surgery

NCT07230561 | Completed

• 2 other identifiers: 113105-FFEMH-2024-C-094
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass

Keywords

Cardiorespiratory Fitness; Coronary Artery Bypass; Early Mobilization; Postoperative Care; Quality of Life; Randomized Controlled Trial; Sarcopenia

Outcome Measures

Primary Outcomes (12)

• 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 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 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 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

Study Arms (2)

Exercise Group

EXPERIMENTAL

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; Other: Standard Hospital Nursing Care

Comparison Group

ACTIVE COMPARATOR

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

Interventions

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.

Exercise Group

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.

Comparison Group; Exercise Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ta-Chung Chao: lead
• Far Eastern Memorial Hospital: collaborator
• Tri-Service General Hospital: collaborator

Study Sites (1)

Far Eastern Medical Foundation Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after the publication of the primary manuscript and will remain available for 5 years.
• 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.

Locations

TW (1)