Coronary Artery Bypass Graft (CABG)ERASNCT07138534
Investigation of the Effect of Prehabilitation Practice on Patient Outcomes in Frail Patients Planned for Elective Coronary Artery Bypass Graft
A study testing prehabilitation in people with Coronary Artery Bypass Graft (CABG), run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
The basic concept of prehabilitation is to increase the functional capacity of the individual to withstand an expected injury. It embodies the idea of being proactive against the common reactive approach of rehabilitation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft (CABG)
- What is being tested?
- prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- frail patient
Who cannot join
- frail patient
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mehmet akif ersoy kalp damar hastanesi
Istanbul
About this study
The basic concept of prehabilitation is to increase the functional capacity of the individual to withstand an expected injury. It embodies the idea of being proactive against the common reactive approach of rehabilitation. While the initial prehabilitation model was limited to physical training, it has now evolved into a multimodal entity that includes nutritional optimisation, psychosocial preparation and smoking cessation in addition to exercise programmes. In the last decade, there has been an increasing effort to coincide prehabilitation with surgery, as surgery is rightly perceived as a stressor for human structural and physiological functions.
Read the detailed description
Frailty is an increasingly recognised risk factor for surgery. The degree of frailty and how this may affect postoperative recovery profiles is unclear. Preoperative frailty may predispose patients to worse outcomes in cardiac surgery; however, there is limited data on how preoperative frailty affects patient outcomes through prehabilitation practices.
- Conditions
- Coronary Artery Bypass Graft (CABG)
- Being tested
- prehabilitation
- Keywords
- frail patients, coronary artery bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prehabilitationBehavioural
In addition to exercise programmes, it includes nutritional optimisation, psychosocial preparation and smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| routine procedure | No intervention | control |
| prehabilitation | Experimental | In addition to exercise programmes, it includes nutritional optimisation, psychosocial preparation and smoking cessation. Receives: Behavioral: prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients' activities of daily living
Patients' daily living activities will be assessed according to the Katz Daily Living Activities Scale. Those with high scores will be shown to have better daily living activities. scale name: Katz activities of daily living. 6 is the highest score and 0 is the lowest. A score of 6 means completely independent.
Measured: It will be measured one month after the surgery. The date may vary depending on the patient.
functional capacity
Patients' functional capacities will be assessed using the Duke Activity Scale. Those with high scores will be confirmed to have better physical and functional capacities. scale name: Duke Activity Status Index. The lowest score is 0 and the highest score is 58.2. A score of 58.2 indicates the highest functional capacity.
Measured: It will be evaluated one month after surgery. The date may vary depending on the patient.
Nutritional Status
Patients' nutrition will be assessed using a mini nutritional test. Those who score high will be assumed to be in good nutritional condition. scale name: Mini nutritional test. The highest score is 14 and the lowest is 0. The highest score indicates the absence of malnutrition.
Measured: It will be evaluated one month after surgery. The date may vary depending on the patient.
Post-operative recovery status
The patient's physical, psychological, bowel activity and general condition will be assessed using a post-operative recovery index. Those with high scores will be considered to have recovered better. The scale name is the postoperative recovery index. The index consists of 5 sub-dimensions and 25 items. The sub-dimensions are psychological symptoms, physical activities, and general symptoms. The ASII total and sub-dimension scores are bowel symptoms and desire-urge symptoms. When determining the subscale score, the scores of the relevant items are summed and the arithmetic mean is calculated. For the total score, all items are summed and the arithmetic mean is calculated. High scores on the index indicate greater difficulty in post-operative recovery, while low scores indicate that post-operative recovery is easier. The ASII is a reliable and valid tool for assessing
Measured: It will be measured one month after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Graft (CABG)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze ataman YILDIZ, Bahçeşehir University
- Investigators
- FATMA ETİ ASLAN, Proffesor, Study director, Bahcesehir Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138534
- Sponsor's protocol ID
- 20250715
- Acronym
- ERAS
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study has not yet begun, so we do not know at this point whether there will be any objections to sharing the data once it has been collected. Therefore, we can say that it will not be shared at this time.
Publications
Steinmetz C, Bjarnason-Wehrens B, Walther T, Schaffland TF, Walther C. Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2023 Apr 1;102(4):323-330. doi: 10.1097/PHM.0000000000002097. Epub 2022 Sep 23.
PubMed 36149383
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Prehabilitation Practice on Patient Outcomes in Frail Patients Planned for Elective Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT07138534
- Acronym / sponsor ID
- ERAS / 20250715
- Conditions
- Coronary Artery Bypass Graft (CABG)
- Keywords
- frail patients, coronary artery bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Aug 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 basic concept of prehabilitation is to increase the functional capacity of the individual to withstand an expected injury. It embodies the idea of being proactive against the common reactive approach of rehabilitation. While the initial prehabilitation model was limited to physical training, it has now evolved into a multimodal entity that includes nutritional optimisation, psychosocial preparation and smoking cessation in addition to exercise programmes. In the last decade, there has been an increasing effort to coincide prehabilitation with surgery, as surgery is rightly perceived as a stressor for human structural and physiological functions.
Detailed description
Frailty is an increasingly recognised risk factor for surgery. The degree of frailty and how this may affect postoperative recovery profiles is unclear. Preoperative frailty may predispose patients to worse outcomes in cardiac surgery; however, there is limited data on how preoperative frailty affects patient outcomes through prehabilitation practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine procedure | No intervention | –control |
| prehabilitation | Experimental | Behavioral: prehabilitationIn addition to exercise programmes, it includes nutritional optimisation, psychosocial preparation and smoking cessation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- frail patient
Key exclusion criteria (1 listed)
- frail patient
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 |
|---|---|---|
| prehabilitationIn addition to exercise programmes, it includes nutritional optimisation, psychosocial preparation and smoking cessation. | Behavioural | prehabilitation |
Primary outcome
patients' activities of daily living
Time frame: It will be measured one month after the surgery. The date may vary depending on the patient.
Patients' daily living activities will be assessed according to the Katz Daily Living Activities Scale. Those with high scores will be shown to have better daily living activities. scale name: Katz activities of daily living. 6 is the highest score and 0 is the lowest. A score of 6 means completely independent.
functional capacity
Time frame: It will be evaluated one month after surgery. The date may vary depending on the patient.
Patients' functional capacities will be assessed using the Duke Activity Scale. Those with high scores will be confirmed to have better physical and functional capacities. scale name: Duke Activity Status Index. The lowest score is 0 and the highest score is 58.2. A score of 58.2 indicates the highest functional capacity.
Nutritional Status
Time frame: It will be evaluated one month after surgery. The date may vary depending on the patient.
Patients' nutrition will be assessed using a mini nutritional test. Those who score high will be assumed to be in good nutritional condition. scale name: Mini nutritional test. The highest score is 14 and the lowest is 0. The highest score indicates the absence of malnutrition.
Post-operative recovery status
Time frame: It will be measured one month after the surgery.
The patient's physical, psychological, bowel activity and general condition will be assessed using a post-operative recovery index. Those with high scores will be considered to have recovered better. The scale name is the postoperative recovery index. The index consists of 5 sub-dimensions and 25 items. The sub-dimensions are psychological symptoms, physical activities, and general symptoms. The ASII total and sub-dimension scores are bowel symptoms and desire-urge symptoms. When determining the subscale score, the scores of the relevant items are summed and the arithmetic mean is calculated. For the total score, all items are summed and the arithmetic mean is calculated. High scores on the index indicate greater difficulty in post-operative recovery, while low scores indicate that post-operative recovery is easier. The ASII is a reliable and valid tool for assessing
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 24 Sep 2026.
- Background: PubMed 36149383Steinmetz C, Bjarnason-Wehrens B, Walther T, Schaffland TF, Walther C. Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2023 Apr 1;102(4):323-330. doi: 10.1097/PHM.0000000000002097. Epub 2022 Sep 23.
- This page is related to Eras cardiac. It is a recommendation from the Eras prehabilitation guidelines. This study was deemed appropriate due to the very low level of evidence.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The study has not yet begun, so we do not know at this point whether there will be any objections to sharing the data once it has been collected. Therefore, we can say that it will not be shared at this time.
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Coronary Artery Bypass Graft (CABG)
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.
FATMA ETİ ASLAN, Proffesor study director
Bahcesehir Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prehabilitation in people with Coronary Artery Bypass Graft (CABG), run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 24 Sep 2026. 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 Turkey (Türkiye). 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?
patients' activities of daily living (time frame: It will be measured one month after the surgery. The date may vary depending on the patient.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138534, which also lists 1 linked publication.
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 24 Sep 2026.