Investigation of the Effect of Prehabilitation Practice on Patient Outcomes in Frail Patients Planned for Elective Coronary Artery Bypass Graft

NCT ID: NCT07138534

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-30

Brief 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. 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.

Conditions

Coronary Artery Bypass Graft (CABG)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

routine procedure

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

prehabilitation

In addition to exercise programmes, it includes nutritional optimisation, psychosocial preparation and smoking cessation.

Group Type: EXPERIMENTAL

prehabilitation

Intervention Type: BEHAVIORAL

In addition to exercise programmes, it includes nutritional optimisation, psychosocial preparation and smoking cessation.

Interventions

prehabilitation

In addition to exercise programmes, it includes nutritional optimisation, psychosocial preparation and smoking cessation.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• frail patient

Exclusion Criteria

• frail patient

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bahçeşehir University

OTHER

Sponsor Role: lead

Responsible Party

Gamze ataman YILDIZ

Surgical Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FATMA ETİ ASLAN, Proffesor

Role: STUDY_DIRECTOR

Bahcesehir Universty

Central Contacts

Gamze Ataman Yıldız, Phd student

Role: CONTACT

gamzeataman39@gmail.com

+905427751780

References

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.

Reference Type: BACKGROUND

PMID: 36149383 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.erascardiac.org/

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.

Other Identifiers

20250715

Identifier Type: -

Identifier Source: org_study_id