The Efficacy of Structured Early Mobilization Training in Patients After Coronary Artery Bypass Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Muscle Mass Proxy (Left Calf Circumference)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Muscle Mass Proxy (Left Calf Circumference)
时间窗: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Maximum circumference (in cm) at the widest part of the calf while seated.
Change in Muscle Mass Proxy (Right Calf Circumference)
时间窗: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Maximum circumference (in cm) at the widest part of the calf while seated.
Change in Cardiorespiratory Fitness
时间窗: 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.
Change in Sarcopenia Risk Classification
时间窗: 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".
Change in Muscle Strength (Left Handgrip)
时间窗: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed by maximal handgrip strength (in kg) using a hydraulic dynamometer.
Change in Muscle Strength (Right Handgrip)
时间窗: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed by maximal handgrip strength (in kg) using a hydraulic dynamometer.
Change in Physical Performance (5-Times Sit-to-Stand Test)
时间窗: 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.
Change in Mood (Anxiety)
时间窗: 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).
Change in Mood (Depression)
时间窗: 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).
Change in Cardiorespiratory Fitness
时间窗: 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.
Change in Sarcopenia Risk Classification
时间窗: 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".
Change in Muscle Strength (Right Handgrip)
时间窗: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed by maximal handgrip strength (in kg) using a hydraulic dynamometer.
Change in Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) Total Score
时间窗: 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).
Change in Muscle Strength (Left Handgrip)
时间窗: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Assessed by maximal handgrip strength (in kg) using a hydraulic dynamometer.
Change in Self-Rated Health
时间窗: 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).
Change in Physical Performance (5-Times Sit-to-Stand Test)
时间窗: 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.
Change in Muscle Mass Proxy (Left Calf Circumference)
时间窗: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Maximum circumference (in cm) at the widest part of the calf while seated.
Change in Muscle Mass Proxy (Right Calf Circumference)
时间窗: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Maximum circumference (in cm) at the widest part of the calf while seated.
Change in Quality of Life
时间窗: 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.
Change in Mood (Anxiety)
时间窗: 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).
Change in Mood (Depression)
时间窗: 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).
次要结局
未报告次要终点
研究者
Ta-Chung Chao
Principal Investigator
National Defense Medical Center, Taiwan