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CTRI Number  CTRI/2024/08/071974 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECT OF PREOPERATIVE PHYSIOTHERAPY TRAINING ON POST-OPERATIVE RECOVERY ON PULMONARY FUNCTIONS IN UPPER ABDOMINAL SURGERY PATIENTS 
Scientific Title of Study   EFFECT OF PREOPERATIVE PATIENT TRAINING ON POST-OPERATIVE RECOVERY IN UPPER ABDOMINAL SURGERY PATIENTS: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SHEETAL MALEKAR 
Designation  ASSISTANT PROFESSOR 
Affiliation  PRAVARA INSTITUTE OF MEDICAL SCIENCES  
Address  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES DU LONI BK TALUKA RAHATA DISTICT AHMADNAGAR
DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES DU LONI BK TALUKA RAHATA
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8999293480  
Fax    
Email  malekarsheetal62@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHEETAL MALEKAR 
Designation  ASSISTANT PROFESSOR 
Affiliation  PRAVARA INSTITUTE OF MEDICAL SCIENCES  
Address  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES DU LONI BK TALUKA RAHATA DISTICT AHMADNAGAR
DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES DU LONI BK TALUKA RAHATA DISTICT AHMADNAGAR
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8999293480  
Fax    
Email  malekarsheetal62@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SHEETAL MALEKAR 
Designation  ASSISTANT PROFESSOR 
Affiliation  PRAVARA INSTITUTE OF MEDICAL SCIENCES  
Address  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES DU LONI BK TALUKA RAHATA DISTICT AHMADNAGAR
DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES DU LONI BK TALUKA RAHATA DISTICT AHMADNAGAR

MAHARASHTRA
413736
India 
Phone  8999293480  
Fax    
Email  malekarsheetal62@gmail.com  
 
Source of Monetary or Material Support  
DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI BK TALUKA RAHATA DISTRICT AHMADNAGAR 
 
Primary Sponsor  
Name  DR SHEETAL MALEKAR 
Address  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI BK TALUKA RAHATA DISTRICT AHMADNAGAR 
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 SHEETAL MALEKAR  PRAVARA RURAL HOSPITAL   PRAVARA RURAL HOSPITAL LONI BK PRAVARA INSTITUTE OF MEDICAL SCIENCES
Ahmadnagar
MAHARASHTRA 		 08999293480

malekarsheetal62@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PRAVARA INSTITUTIONAL ETHICAL ECOMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GROUP A CONVENTIONAL PHYSIOTHERAPY TRAINING  TOTAL 8 DAYS OF PHYSIOTHERAPY PROGRAMME Post-operative conventional Physiotherapy: 1. Breathing exercises (Diaphragmatic breathing, Thoracic expansion exercise) 2. Ambulation. – Sit out of bed Walk 5m with assistance Walk 15 m with assistance Walk 30 m with assistance Walk 30m without assistance. 3. Coughing technique.  
Comparator Agent  GROUP B PREOPERATIVE AND POSTOPERATIVE PHYSIOTHERAPY TRAINING   3 DAYS PRIOR TO OPERATION AND 8 DAYS OF POSTOPERATIVE TRAINING Pre- operative Physiotherapy: DAYS EXERCISE PROTOCOL 1 day prior to operation 1 hour educational training with the help of information booklet and explain the incidence of complications after a surgery. Explanation of exercise protocol and importance of physiotherapy exercises in prevention of PPC. 1 Day prior to operation Incentive spirometry 10 times/2 hour with 3secs hold Post-operative physiotherapy – DAYS EXERCISE PROTOCOL DAY 1 TENS, Breathing exercises , Ankle pumps , Heel slide , LIPPSMAck POP stage 1 , Incentive spirometry DAY 2 TENS, Breathing exercises (Diaphragmatic breathing, Thoracic expansion exercise), ankle pumps, heel slide , Incentive spirometry LIPPSMAck POP stage 2 DAY 3 TENS, Breathing exercises, LIPPSMAck POP stage 3, Incentive spirometry DAY 4 Breathing exercises, LIPPSsMAck POP stage 4 , Coughing , Incentive spirometry DAY 5 Breathing exercises, LIPPSMAck POP stage 5 , Coughing , Incentive spirometry DAY 6 Breathing exercises, LIPPSMAck POP stage 6 DAY 7 Breathing exercises, LIPPSMAck POP stage 7  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants with upper abdominal surgery within age group of 18-60 years.

Only elective upper abdominal surgery patients are included.

Participants who are signed consent form of the study


Patients who will be undergoing abdominal surgery after 3 days of enrollment

 
 
ExclusionCriteria 
Details  Participants who are not signed consent form of the study

Postoperative hemodynamic instability
Postoperative ventilators
Age more than 60 years

Patients stay in the intensive care unit for a longer time during the postoperative period.

If patients required organ transplants, required abdominal hernia repairs, unable to ambulate for more than one minute, and will unable to participate in a single physiotherapy preoperative session.

Patients undergoing video assisted laparoscopy surgery.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
POSTOPERATIVE DISCHARGE SCORING TOOL
 		 1 DAY AND 8 DAY 
 
Secondary Outcome  
Outcome  TimePoints 
DEMORTON MOBILITY INDEX  1 DAY AND 8 DAY OF INTERVENTION  
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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   N/A 
Date of First Enrollment (India)   02/12/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

BACKGROUND -

Surgical care has a role in treating a broad spectrum of diseases in the alleviation of human suffering.1 The estimated need for surgical procedures worldwide is large and addresses widespread of disease states. Surgery is essential for addressing basic health needs globally, although the degree varies between epidemiological regions of the world and between disease subcategories. Surgical need varies between regions of the world according to disease prevalence and many countries do not meet the basic needs of their populations.1According to WHO, at least 321·5 million surgical procedures would be needed to address the burden of disease for a global population of 6·9 billion. A large volume of surgical need, estimates one procedure per 21 people alive today, with a global rate of surgery of 4664 per 100, 000. After major abdominal surgery, mobilisation and oxygen-hemoglobin saturation were improved, and the frequency of postoperative pulmonary problems was decreased thanks to preoperative chest physical therapy. "Hence, therefore aim of our study to find the effect of structured programme consisting of a combination pre and post-operative Physiotherapy programme in upper abdominal surgery patients.

NEED FOR THE STUDY –

Surgery is a foundational component of health-care systems and it has a direct effect on the respiratory system. It alters postoperative pulmonary function, as observed by impairment of lung volumes such as total lung capacity, vital capacity and tidal volume. Abdominal surgery is the most major surgical procedure performed in developed countries. A postoperative pulmonary complication (PPC) is the most common serious complication after the surgery. As few studies, have only shown the preoperative education or either particularly postoperative physiotherapy programme for abdominal surgery patients. Our study aims to form a structured intervention comprising of pre-operative education and its effect on post-operative pulmonary complications and discharge from hospital.

According to the International Association for the Study of Pain, pain is an unpleasant sensory and emotional experience related to actual or potential tissue damage. Postoperative pain is the most common symptom encountered by hospitalized surgical patients. This increases the prevalence of postoperative morbidity and leads to delayed recovery. For that preoperative education and postoperative physiotherapy programme helps the patient to get recover from pain as soon as possible and leads to reduction in hospital stay. The pre-operative education component will help in patient’s understanding of complications after surgery. The post-operative Physiotherapy exercise programme will focus on improvement of respiratory muscle strength, oxygenation, coughing mechanism, chest wall mobility and lung ventilation, as well as decreasing respiratory work and preventing postoperative pulmonary complications. Preoperative educational training will reduce the incidence of PPC with postoperative interventional programme. Hence, aim of this study find the effect of structured programme consisting of a combination pre and post-operative Physiotherapy programme in upper abdominal surgery patients.

 

 

 

 

 

 

 

 

AIM –

To find the effect of a newly structured intervention Physiotherapy programme consisting of a combination of pre and postoperative Physiotherapy in upper abdominal surgery patients.

 

 

OBJECTIVES-

Primary Objective:

Ø  To find out the effect of pre and post-operative Physiotherapy in upper abdominal surgery patients.

Ø  To minimize hospital stay of patients after the upper abdominal surgery.

Secondary Objective:

Ø  To make information brochure & Audio-visual video containing information of post- operative complications and physiotherapy exercise programme.

Ø  To find out the effect of pre and post-operative Physiotherapy on pain measured with NPRS in abdominal surgery patients.

METHODOLOGY

Ø  Type of data: Data will be primarily collected by principal investigator.

Ø  Study setting – Pravara medical trust hospital (PIMS -DU) Loni

Ø  Study design: A Randomized controlled Trial

Ø  Sample size: 110 participants.

Ø  Sampling method: simple random sampling

Ø  Study duration: 3 years.

 

Materials to be used:

·       Consent form

·       Data collection sheet

·       Numerical Pain Rating Scale (NPRS)

·       POPDST (Postoperative physiotherapy discharge scale)

·       Melbourne postoperative Pulmonary complications criteria

·       De Morton Mobility Index (DEMMI)

 

 

 

 

OUTCOME MEASURE -

 

1.     Satisfaction: Patient satisfaction of the intervention will be measured at the follow-up visit within 1 week before surgery using a self-reported questionnaire.

2.     NPRS – For post-operative pain at suture site.

3.   POP-DST – To measure PPCs after the surgery.

4.     MGS - To measure PPCs after the surgery.

5.     De Morton Mobility Index (DMEI) – Health Related Quality of life 

 

 
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