NCT07138534

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 5, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

frail patientscoronary artery bypass

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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

    It will be measured one month after the surgery.

Study Arms (2)

routine procedure

NO INTERVENTION

control

prehabilitation

EXPERIMENTAL

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

Behavioral: prehabilitation

Interventions

prehabilitationBEHAVIORAL

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

prehabilitation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • frail patient

You may not qualify if:

  • frail patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36149383BACKGROUND

Related Links

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • FATMA ETİ ASLAN, Proffesor

    Bahcesehir Universty

    STUDY DIRECTOR

Central Study Contacts

Gamze Ataman Yıldız, Phd student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Nurse

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 24, 2025

Study Start

September 1, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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.