Effects of Prehabilitation on Postoperative Recovery

Lung Cancer Clinical Trial

Official title:

Effects of Prehabilitation on Postoperative Recovery in Patients Undergoing Lung Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05891340
• Other study ID #: 2022/2131
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study.

Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Prehabilitation consists of respiratory muscle exercise and walking is recommended to Intervention Group.

Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day and 1st month. The intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.

Description:

The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study. Patients will be informed about the study and their written consent will be obtained. Patients who do not give consent will not be included in the study.

Routine preoperative evaluation including detailed history (daily physical activity, clinical complaints at rest or exertion, if any) and physical examination will be performed on the patients. Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Preoperative exercise, alcohol and smoking cessation are recommended to all patients. Prehabilitation consists of respiratory muscle exercise with inspiratory muscle trainer (two times a day) and walking (5000steps/day) is recommended to Intervention Group. Hospitalized patients are followed up with daily visits, and patients who are at home are followed up by phone call. All patients' induction of anesthesia and maintenance were similar.

Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day (as primary outcome) and 1st month. The duration of anesthesia, surgery duration, intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA physical status classification system score 1-3 patients

• Patients who underwent lung resection

• Patients who agreed to participate in the study and gave written informed consent

Exclusion Criteria:

• Re-operation

• Emergency operations

• Patients with psychiatric drug use

• unability for physical exercise

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Other:
• Respiratory muscle exercise
respiratory muscle exercise with inspiratory muscle trainer (two times a day)
• Endurance exercise
walking exercise 5000 steps/day

Locations

Country	Name	City	State
Turkey	Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery at postoperative second day	The primary aim of our study is to compare recovery of patients who have prehabilitation programme and who have not any programme by using QoR-15 questionnaire on the 2nd postoperative day.	two days
Secondary	Quality of recovery at postoperative first month	Investigating recovery of patients by by using QoR-15 questionnaire	one month
Secondary	length of intensive care unit stay	Investigating planned or unplanned ICU admission	two weeks
Secondary	Length of hospital stay	patients' length of stay	one month
Secondary	Postoperative pulmonary complications	Patients' pulmonary complications such as pneumonia, atelectasis, hemorrhage, emphysema, prolonged air leak, chylothorax and respiratory failure.	one month