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| ID | Type | Description | Link |
|---|---|---|---|
| FEMH-2024-C-094 | Other Grant/Funding Number | Far Eastern Medical Foundation Far Eastern Memorial Hospital |
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| Name | Class |
|---|---|
| Far Eastern Memorial Hospital | OTHER |
| Tri-Service General Hospital (TSGH) | OTHER |
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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:
Participants in the exercise group will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Medical Foundation Far Eastern Memorial Hospital | New Taipei City | 220 | Taiwan |
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.
Data will be available beginning 6 months after the publication of the primary manuscript and will remain available for 5 years.
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.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
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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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |