- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05891340
Effects of Prehabilitation on Postoperative Recovery
Effects of Prehabilitation on Postoperative Recovery in Patients Undergoing Lung Resection
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Istanbul Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Preoperative exercise, alcohol and smoking cessation are recommended to patients.
|
|
|
Active Comparator: Intervention
Respiratory muscle exercise (two times a day) and walking (5000steps/day) are recommended to the patients preoperatively.
|
respiratory muscle exercise with inspiratory muscle trainer (two times a day)
walking exercise 5000 steps/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of recovery at postoperative second day
Time Frame: two days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of recovery at postoperative first month
Time Frame: one month
|
Investigating recovery of patients by by using QoR-15 questionnaire
|
one month
|
|
length of intensive care unit stay
Time Frame: two weeks
|
Investigating planned or unplanned ICU admission
|
two weeks
|
|
Length of hospital stay
Time Frame: one month
|
patients' length of stay
|
one month
|
|
Postoperative pulmonary complications
Time Frame: one month
|
Patients' pulmonary complications such as pneumonia, atelectasis, hemorrhage, emphysema, prolonged air leak, chylothorax and respiratory failure.
|
one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022/2131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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