Investigation of the Effect of Prehabilitation Practice on Patient Outcomes in Frail Patients Planned for Elective Coronary Artery Bypass Graft
Phase: NA
Conditions: Coronary Artery Bypass Graft (CABG)
Sponsor: Bahçeşehir University

Turkish Republic 
Ministry of Health 
SBU. Istanbul Mehmet Akif Ersoy 
Thoracic, Cardiovascular and Vascular Surgery Training and Research Hospital 
Scientific Research Ethics Committee 
 
SS.YD.05  
Publication Date: 21.02.2024 / Rev. No.: 01 / Rev. Date: 11.03.2024  
 1/7 
RESEARCH PROTOCOL 
……/…../20.… 
 
Investigation of the Effect of Prehabilitation on Patient Outcomes in Frail Patients Planned for 
Elective Coronary Artery Bypass Graft 
 
Protocol No.               :230219 
 
Research Type  
: 
 
Research Center: University of Health Sciences Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and 
Research Hospital 
 
Supporter (If Any): None 
 
Application  
 
: 
Individual Research   
Thesis 
 
We undertake that we have read the current versions of the Declaration of Helsinki, Good Clinical Practices (GCP) Guide 
and Good Laboratory Practices (GLP) Guide and that the study will be conducted in accordance with this Research Protocol, the 
Declaration of Helsinki, GCP/GLP. In addition, the researchers mentioned below have been informed in detail about the study by 
the Coordinator (multicenter) / Principal Investigator (single center) of this study. 
 
 
Responsible Researcher: Specialist Nurse Gamze ATAMAN YILDIZ 
History   
: 
Signature  
 
: 
 
Consultant Researcher: Prof. Dr. Fatma ETİ ASLAN 
History   
: 
Signature  
 
: 
 
 
 
 
1 In single-center studies, the coordinating investigator is the principal investigator. In multi-center studies, the principal 
investigator of the center where the study will be conducted is the Coordinating Investigator. 
 
2 You can duplicate the responsible and assistant worker fields. 
 
CONTACT INFORMATION 3 
 
Position   
 
: Principal Researcher 
Name/SURNAME   
: Gamze ATAMAN YILDIZ 
Address/Department  
 
: SBU Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research 
Hospital 
Phone   
 
: 0 542 775 17 80 
Email  
 
:  
gamze ataman39@gmail.com 
 
Position   
 
: Consultant Researcher 
Name/SURNAME   
: Prof. Dr. Fatma ETİ ASLAN 
Address/Department  
 
: Bahçeşehir University Nursing Department 
Phone   
 
: 0 532 273 90 70 
E-mail   
 
: fatma.eti@bau.edu.tr 
 
 
 
 
 
 

Turkish Republic 
Ministry of Health 
SBU. Istanbul Mehmet Akif Ersoy 
Thoracic, Cardiovascular and Vascular Surgery Training and Research Hospital 
Scientific Research Ethics Committee 
 
SS.YD.05  
Publication Date: 21.02.2024 / Rev. No.: 01 / Rev. Date: 11.03.2024  
 2/7 
 
3 You can add according to the number of principal investigators and assistant investigators. 
CONTENTS 
 
1. 
Summary 
2. 
Abbreviations 
3. 
Work Schedule and Duration 
4. 
Rationale / Importance and Contribution of the Research 
5. 
Objectives 
6. 
Expected Benefits from the Research 
7. 
Type of Research 
8. 
Population to be Examined 
9. 
Research Method 
10. 
Investigational Product / Treatment 
11. 
Research Design / Method 
12. 
Procedure to Follow 
13. 
Evaluation and Parameters to be Recorded 
14. 
Research Centers 
15. 
Statistics 
16. 
Informed Consent 
17. 
Research Budget 
18. 
Literature 
 
 
1. 
SUMMARY 
 
Title of the Study  
: Investigation of the Effect of Prehabilitation on Patient Outcomes in Frail Patients Planned for Elective 
Coronary Artery Bypass Graft 
Rationale  
 
: To see the effect of preoperative routine and improved practices on the patient after surgery. 
Purpose  
 
: The purpose of the research is, To determine the effect of prehabilitation care on patient outcomes. 
Objective  
 
 
: To evaluate the effect of preoperative prehabilitation on patient outcomes and contribute to 
the literature. 
Population  
 
: Frail patients scheduled for elective coronary artery bypass grafting at the University of Health 
Sciences, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. 
 
Number of Volunteers  
 
: The sample calculation of the study was made using Power (G-power) analysis, and the 
minimum sample size was calculated as 30 patients for both groups, while the Type I error amount was 0.05 and the power of the 
test was 0.80 (α=0.05, 1-β=0.80). 
Research Design  : The study was planned as a randomized controlled trial. 
Procedure  
 
 
: After obtaining institutional approval, the study will continue until the sample size is reached 
with patients who meet the criteria. Patients identified with the preoperative mini mental test and frailty scale will be administered 
a patient information form, mini nutritional test, Charlson Comorbidity Index, and Duke activity status index 3-4 weeks before 
surgery in the intervention group, and 1 day before surgery in the control group. Before postoperative discharge, the appropriate 
section of the patient information form and the Clavien Dindo classification will be administered and recorded. On the 30th 

Turkish Republic 
Ministry of Health 
SBU. Istanbul Mehmet Akif Ersoy 
Thoracic, Cardiovascular and Vascular Surgery Training and Research Hospital 
Scientific Research Ethics Committee 
 
SS.YD.05  
Publication Date: 21.02.2024 / Rev. No.: 01 / Rev. Date: 11.03.2024  
 3/7 
postoperative day, the mini nutritional test, Duke activity status index, activities of daily living scale, and postoperative recovery 
index will be administered and recorded. 
Research Duration  
 
: After obtaining institutional permission, the study will continue until the sample size is reached 
on patients who meet the criteria. 
 
2. 
ABBREVIATIONS 
 
 
3. 
WORKING SCHEDULE AND DURATION 
 
May 
27, 
2025 
May 
28, 
2025 
- 
January 1, 
2026
January 1, 
2026 
– 
April 
1, 
April 2026 
May 2026 
May 2026 
May 2026 
Obtaining ethics committee 
approval 
- 
Data collection 
- 
Literature review 
- Writing phase of the 
research 
- 
Analysis 
- 
Analysis interpretation 
- 
Discussing analyses 
- 
Writing and presenting 
research results 
4. 
RATIONALE / IMPORTANCE AND CONTRIBUTION OF THE RESEARCH 
 
Frailty is multifactorial, making it difficult to estimate its prevalence; older age, female gender, unhealthy lifestyle, and low 
economic status have been identified as potential risk factors. Social factors such as marital status, smoking history, social 
isolation, and low education levels also place individuals at risk (Dent, E., et al. 2019; Dent, E., et al. 2019). Research suggests that 
frailty increases with the number of health deficits and the presence of multiple comorbidities. Higher rates of frailty have been 
documented in patients diagnosed with diabetes, respiratory disease, stroke, dementia, multiple sclerosis, connective tissue 
disease, osteoarthritis, and chronic fatigue syndrome (Liu, X., et al. 2019). 
There is currently no recommendation to routinely screen for frailty. However, to optimize care and communicate 
appropriately with families, clinicians may need to identify at-risk patients and those who may already be frail (Hsieh, T.J., et al. 
2019). Frailty is not defined by a single patient-reported symptom or physical examination finding, and no single laboratory test or 
imaging study can diagnose frailty. Instead, frailty is assessed through a comprehensive history and physical examination, focusing 
on several key elements (Arrieta, H., et al. 2019). A patient considered frail should be assessed using validated frailty assessment 
tools. A suggested approach to optimizing preoperative care is presented, which includes recommendations for identifying 
underlying physical disability, malnutrition, cognitive dysfunction, and mental health diagnoses following frailty assessment (Braun, 
T., et al. 2019). 
The fundamental concept of prehabilitation is to increase an individual's functional capacity to withstand an anticipated 
injury. It embodies the idea of a proactive approach to rehabilitation, as opposed to the reactive approach commonly used in 
rehabilitation (Esser, T., Zimmer, P., Schier, R. 2022). While the initial prehabilitation model was limited to physical training, it has 
evolved into a multimodal entity that, in addition to exercise programs, includes nutritional optimization, psychosocial preparation, 
and smoking cessation. Over the past decade, there has been an increasing effort to coincide prehabilitation with surgery, as 
surgery is rightfully perceived as a stressor for human structural and physiological functions (McIsaac, DI., et al. 2022). 

Turkish Republic 
Ministry of Health 
SBU. Istanbul Mehmet Akif Ersoy 
Thoracic, Cardiovascular and Vascular Surgery Training and Research Hospital 
Scientific Research Ethics Committee 
 
SS.YD.05  
Publication Date: 21.02.2024 / Rev. No.: 01 / Rev. Date: 11.03.2024  
 4/7 
5. 
PURPOSES 
 
The aim of the study is to determine the effect of prehabilitation care on patient outcomes. 
 
6. 
EXPECTED BENEFITS FROM THE RESEARCH 
 
Frailty is an increasingly recognized risk factor for surgery. The degree of frailty and how it may impact postoperative recovery 
profiles are unclear. Preoperative frailty may predispose patients to poorer outcomes in cardiac surgery; however, there are limited 
data on how preoperative frailty impacts patient outcomes through prehabilitation practices. 
7. 
TYPE OF RESEARCH 
 
Prospective 
Retrospective 
Descriptive studies 
Descriptive 
Analytical studies 
Observational studies 
Cross-sectional studies 
Cohort studies (prospective, retrospective, bidirectional) 
Case-control studies 
Qualitative analyses 
Survey studies 
Case-control studies 
 
Randomized 
Non-Randomized 
 
Self-Control (Paired Series) 
Cross-Checked  
Externally Controlled 
 
Those Without a Control Group  
Meta-Analyses  
 
Methodological Research 
Experimental Studies (No Direct Intervention, No Drug or Medical Device Studies) 
In vitro studies 
Studies to be conducted with blood, urine and pathology collection materials 
Cell and tissue culture studies 
Studies with genetic material that are for identification purposes and are not included in gene therapy clinical trials 
 
 
 
 
8. 
POPULATION TO BE STUDIED 
 

Turkish Republic 
Ministry of Health 
SBU. Istanbul Mehmet Akif Ersoy 
Thoracic, Cardiovascular and Vascular Surgery Training and Research Hospital 
Scientific Research Ethics Committee 
 
SS.YD.05  
Publication Date: 21.02.2024 / Rev. No.: 01 / Rev. Date: 11.03.2024  
 5/7 
How was the sample size decided: It was decided by G-power analysis. 
Number of volunteers planned to be included: 30+30 
Volunteer Age Range: 60+ 
• 
Agreeing to participate in the research, 
• 
Undergoing elective open coronary artery bypass grafting 
• 
Being 60 years old or older, 
• 
Being in the frail patient status as a result of the FRIED Frailty Scale, 
• 
Being able to communicate in Turkish.  
Exclusion Criteria: Patients whose surgery has been postponed and those whose mini mental test result is 23 or below will not be 
included. 
Gender: Male and female 
Are there any vulnerable groups/individuals (children, disabled people, unconscious individuals) planned to be 
included? 
 
Yes 
No 
 
9. 
RESEARCH METHOD 
 
Data for the study will be collected in two stages. In stage 1, patients will be visited before surgery (3-4 weeks before for the 
intervention group, 1 day before for the control group) and informed about the researchers and the study. Patients who agree to 
participate and meet the inclusion criteria will be included in the study. Patients will be interviewed face-to-face, and they will 
complete a patient information form prepared by the researchers based on literature, a mini nutritional test, a 6-minute walk test, 
and the Borg scale. The intervention group will receive prehabilitation, while the control group will receive routine procedures. 
Postoperatively, patients will complete a patient information form before discharge, and on the 30th day after surgery, a mini 
nutritional test, an activities of daily living scale, a postoperative recovery index, a 6-minute walk test, and the Borg scale. 
 
10. 
RESEARCH PRODUCT / TREATMENT 
 
No products or drugs will be used in the study. 
11. 
RESEARCH DESIGN / METHOD 
 
 
The study was planned as a randomized controlled trial. 
 
12. 
PROCEDURE TO FOLLOW 
The study was planned as a randomized controlled trial to be conducted at the cardiovascular surgery clinic of the Istanbul Mehmet 
Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. Patients meeting the sample selection criteria will 
be included in two groups. Data will be collected using a patient information form, mini nutritional test, Borg scale, activities of 
daily living scale, and postoperative recovery index. A 6-minute walk test will be administered and recorded. All data will be 
collected by the researchers. 

Turkish Republic 
Ministry of Health 
SBU. Istanbul Mehmet Akif Ersoy 
Thoracic, Cardiovascular and Vascular Surgery Training and Research Hospital 
Scientific Research Ethics Committee 
 
SS.YD.05  
Publication Date: 21.02.2024 / Rev. No.: 01 / Rev. Date: 11.03.2024  
 6/7 
 
13. 
EVALUATION AND PARAMETERS TO BE RECORDED 
 
 
Patients will be interviewed face-to-face and a "Patient Information Form," prepared by the researchers based on literature, will be 
completed. A mini mental test and frailty scale will be used to select patients. A preoperative mini nutritional test, comorbidity 
scale, 6-minute walk test, and Borg scale will be used for both groups. A patient information form and complication classification 
will be completed before discharge. On the 30th postoperative day, a mini nutritional test, activities of daily living scale, 
postoperative recovery index, 6-minute walk test, and Borg scale will be used. 
 
14. 
RESEARCH CENTERS 
 
 
Center: Republic of Turkey Ministry of Health, SBU. Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and 
Research Hospital 
Researcher Name Surname: Gamze Ataman Yıldız 
 
15. STATISTICS 
 
The data obtained in the study will be analyzed using SPSS 25.0. Descriptive statistical methods such as number, percentage, 
mean, and standard deviation will be used in the data analysis. Based on the results, the data will be analyzed using relevant tests 
(t-test, chi-square, Man-Whitney U, Fisher's exact, and regression analysis). 
 
H0: Prehabilitation does not affect patient outcomes in fragile cases undergoing elective coronary artery bypass grafting. 
H1: Prehabilitation affects patient outcomes in fragile cases undergoing elective coronary artery bypass grafting. 
 
 
 
16. SUB-STUDY 
 
 
No. 
 
17. 
INFORMED VOLUNTARY CONSENT 
 
Before the surgery, the patient will be visited in the room, informed and consent will be obtained before data collection. 
 
18. 
RESEARCH BUDGET 
 
Budget 
Coverage of research expenses & Sponsor declaration 
(The costs of tests and laboratory examinations performed on volunteers for research purposes cannot be covered by public or 
private health insurance, nor can they be paid by the volunteers. The costs of all research-related procedures, such as printing 
survey/interview forms, fees for services such as consultancy, tests, and laboratory examinations received from within or outside 
the institution, reimbursement of volunteer expenses, telephone charges to reach volunteers, payments to 
researchers/interviewers, etc., must be planned and their source must be explained.) 
 
There are no anticipated expenses. 
Research Funds (TÜBİTAK etc. Please write the name: …………………………….. 
Other (Please Explain): ...................................... 

Turkish Republic 
Ministry of Health 
SBU. Istanbul Mehmet Akif Ersoy 
Thoracic, Cardiovascular and Vascular Surgery Training and Research Hospital 
Scientific Research Ethics Committee 
 
SS.YD.05  
Publication Date: 21.02.2024 / Rev. No.: 01 / Rev. Date: 11.03.2024  
 7/7 
Research expense items 
(Adjust the possible expense items below according to your research. You can add or 
remove items if necessary. If there are no projected expenses, leave them blank.) 
AMOUNT 
Payments to researchers 
 
Payments to be made to the research institution 
 
Payments to be made to volunteers 
 
Service purchases from the research site 
 
Service purchases outside the research site 
 
Consumable purchases 
 
Stationery purchases 
 
Travel expenses 
 
 
 
19. LITERATURE 
 
1. Chia-Hui Chen, C., Yang, YT, Lai, IR, Lin, BR, Yang, CY, Huang, J., Tien, YW, Chen, CN, Lin, MT, Liang, JT, Li, HC, Huang, GH, & 
Inouye, SK (2019). Three Nurse-administered Protocols Reduce Nutritional Decline and Frailty in Older Gastrointestinal Surgery 
Patients: A Cluster Randomized Trial. Journal of the American Medical Directors Association , 20 (5), 524–529.e3. 
https://doi.org/10.1016/j.jamda.2018.09.016 
2.  
3.