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CTRI Number  CTRI/2025/06/089867 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Exercise program and nutritional therapy for optimizing post operative pulmonary outcomes in patients undergoing upper abdominal surgeries. 
Scientific Title of Study   Targeted Prehabilitation based on PEFR thresholds for optimizing post operative pulmonary outcomes in patients undergoing upper abdominal surgeries. 
Trial Acronym  Targeted Prehabilitation based on PEFR thresholds for optimizing post operative pulmonary outcomes in patients undergoing upper abdominal surgeries: A Prospective interventional study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meghana P 
Designation  Post graduate in Department of Anaesthesiology 
Affiliation  Rajarajeshwari Medical College and Hospital 
Address  Department of Anesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka

Bangalore
KARNATAKA
56074
India 
Phone  9945228822  
Fax    
Email  meghana948@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sowmya M Jois 
Designation  Associate Professor 
Affiliation  Rajarajeshwari Medical College and Hospital 
Address  Department of Anesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9980891082  
Fax    
Email  Drsowmyasharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sowmya M Jois 
Designation  Associate Professor 
Affiliation  Rajarajeshwari Medical College and Hospital 
Address  Department of Anesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9980891082  
Fax    
Email  Drsowmyasharma@gmail.com  
 
Source of Monetary or Material Support  
Departement of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka  
 
Primary Sponsor  
Name  Dr Meghana P 
Address  Departement of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka 560074 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meghana P  Departement of Anaesthesiology, Rajarajeshwari medical college and hospital.   2nd floor Hospital Building, Departement of Anaesthesiology, Rajarajeshwari Medical College and Hospital, Mysore road, Kambipura, Bangalore, Karnataka
Bangalore
KARNATAKA 
9945228822

meghana948@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PEFR on post operative day 1   PEFR will be measured on post operative day 1 and will be compared with PEFR before surgery to check whether there’s any improvement in PEFR due to Prehabilitation 
Comparator Agent  PEFR pre operative day   PEFR will be measured on pre operative day and will be compared with PEFR on post operative day 1 to see improvement with Prehabilitation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  a) ASA I, II, III patients of either sex.
b) Patients aged between 18 to 75 years.
c) Patients undergoing elective upper abdominal and thoracic surgeries under
general anesthesia resulting in a minimum hospital stay of at least 2 days, excluding day case surgery
d) Patients willing to participate in this study. 
 
ExclusionCriteria 
Details  a) Patients not willing to participate in this study.
b) Patients with ASA grade IV
c) Patients undergoing emergency surgeries
d) Inability to perform PEFR
e) Baseline PEFR <30% of predicted values.
f) Recent hospitalization for severe illness (<6months).
g) Body mass index in >30kg/m2 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Primary Objective is to evaluate the effectiveness of PEFR guided Prehabilitation in reducing the
incidence of post operative pulmonary complications (pneumonia, post
operative ventilation, atelectasis, desaturation, requirement of O2 therapy
post operatively).
and Improving functional recovery in patients undergoing elective upper
abdominal surgeries. 
Pre operative day 3, 2, 1 and Post operative day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in PEFR from preoperative visit to the day after surgery and Duration of hospital stay and any ICU admission.  Post operative day 1 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Targeted Prehabilitation focusing on respiratory optimization has shown promise in reducing post operative complications.Peak expiratory flow rate (PEFR) is a simple and reliable measure of airway obstruction and Pulmonary function, and it can be used to serve as an essential tool for tailoring Prehabilitation programmes. Prehabilitation is a multidisciplinary healthcare intervention including exercise, nutritional optimization, and psychological preparation, to dampen the metabolic response to surgery, better withstand a stressful event, shorten the period of recovery, reduce complications, and improve the quality of recovery and quality of life.  During upper abdominal surgeries, intraoperative changes in pulmonary function occur due to decreased lung compliance. In our study, 42 patients of ASA I, II, III aged between 18 and 75 years scheduled for elective surgeries under general anaesthesia will be selected based on inclusion or exclusion criteria. They will be categorized into Mildly reduced PEFR and Severely reduced
PEFR. Patients will receive targeted PEFR guided Prehabilitation. During Preoperative checkup PEFR will be done using Peak flow meter. PEFR will be measured with a portable device, the Mini Portable Peak Flow Meter ranging from 60 to 800 l/min, according to the Guidelines for Pulmonary Function Tests, 2002, with the patient sitting. Patients will be instructed to exert a maximal inspiration to total lung capacity followed by a maximal, short and explosive forced expiration through the measuring device, without extending the measure to residual volume. The expiratory effort needed last only a second or two. Test will be repeated the test three times, considering the best result if the readings did not differ more than 20 ml/ min from each other.  After performing, patients will be classified into 2 categories, i.e, mildly reduced PEFR (60-80%) and severely reduced PEFR (less than 60%). Mildly reduced PEFR group will receive following interventions without supervision at home or in hospital during their stay: Psychological preparation, Dietitian suggested meals with good sugar control, Smoking cessation, Deep breathing exercises that include Incentive spirometry, Aerobic exercises, Coughing and huffing exercises. Severely reduced PEFR group will receive above mentioned interventions as well as extra interventions like the following: Assisted Physiotherapy and Bronchodilator therapy. Both groups will be counseled and prepared psychologically as to why Pre Operative preparation is important. Dietician opinion will be provided regarding the diet they have to follow Preoperatively. Patients who smoke cigarettes or beedis will be advised to stop smoking. They will be made to part in a training program 3 sessions for 3 days before surgery designed to improve the strength and endurance of the inspiratory muscles. A daily diary will be given to each participant to follow up on both exercise training and nutrition requirements so as to evaluate the effectiveness of Prehabilitation in reducing the incidence of post operative pulmonary
complications and improvement in PEFR from preoperative visit to the day after surgery, duration the course of hospital stay and ICU admission (if any).
 
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