Coronary Artery DiseaseEMACNCT07230561
Early Mobilization After CABG Surgery
A study testing Structured Early Mobilization Training and Standard Hospital Nursing Care in people with Coronary Artery Disease and Coronary Artery Bypass, run by Ta-Chung Chao at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass
- What is being tested?
- Structured Early Mobilization Training and Standard Hospital Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Far Eastern Medical Foundation Far Eastern Memorial Hospital
New Taipei City, 220
About this study
Official title: 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.
Read more
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
- Being tested
- Structured Early Mobilization Training, Standard Hospital Nursing Care
- Keywords
- Cardiorespiratory Fitness, Coronary Artery Bypass, Early Mobilization, Postoperative Care, Quality of Life, Randomized Controlled Trial, Sarcopenia
- Medical subject headings
- Coronary Artery Disease, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Early Mobilization TrainingBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Hospital Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ta-Chung Chao
- Sponsor type
- University, hospital or other
- Collaborators
- Far Eastern Memorial Hospital, Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor-investigator, Ta-Chung Chao, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230561
- Sponsor's protocol ID
- 113105-F
- Other IDs
- FEMH-2024-C-094
- Acronym
- EMAC
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Structured Early Mobilization Training in Patients After Coronary Artery Bypass Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07230561
- Acronym / sponsor ID
- EMAC / 113105-F
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass
- Keywords
- Cardiorespiratory Fitness, Coronary Artery Bypass, Early Mobilization, Postoperative Care, Quality of Life, Randomized Controlled Trial, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ta-Chung ChaoUniversity, hospital or other
- Collaborators
- Far Eastern Memorial Hospital, Tri-Service General Hospital (TSGH)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Structured Early Mobilization Training, Other: Standard Hospital Nursing CareParticipants 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. |
| Comparison Group | Active comparator | Other: Standard Hospital Nursing CareParticipants 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Early Mobilization TrainingThe 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. | Behavioural | Exercise Group |
| Standard Hospital Nursing CareThe 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. | Other | Comparison Group, Exercise Group |
Primary outcome
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.
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".
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).
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.
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.
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.
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.
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.
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.
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Early Mobilization Training and Standard Hospital Nursing Care in people with Coronary Artery Disease and Coronary Artery Bypass, run by Ta-Chung Chao at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiorespiratory Fitness (time frame: Baseline (preoperative at admission), Postoperative Day 6, Postoperative Day 14). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.