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CTRI Number  CTRI/2020/12/030009 [Registered on: 23/12/2020] Trial Registered Prospectively
Last Modified On: 19/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Home-based exercise program in major abdominal surgeries to improve exercise tolerance, which may help in better recovery. 
Scientific Title of Study   Individualised home-based exercise program in major gastrointestinal surgeries as a part of prehabilitation: a randomised clinical trial. 
Trial Acronym  IMPACT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RESHMA AMBULKAR 
Designation  PROFESSOR 
Affiliation  TATA MEMORIAL CENTRE 
Address  Department of Anaesthesia, 2nd floor, main building, major OR complex, Tata Memorial Hospital, Ernest Borges Rd, Parel,400012, Mumbai
Department of Anaesthesia, 2nd floor, main building, major OR complex, Tata Memorial Hospital, Ernest Borges Rd, Parel,400012, Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RESHMA AMBULKAR 
Designation  PROFESSOR 
Affiliation  TATA MEMORIAL CENTRE 
Address  Department of Anaesthesia, 2nd floor, main building, major OR complex, Tata Memorial Hospital, Ernest Borges Rd, Parel,400012, Mumbai
Department of Anaesthesia, 2nd floor, main building, major OR complex, Tata Memorial Hospital, Ernest Borges Rd, Parel,400012, Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  RESHMA AMBULKAR 
Designation  PROFESSOR 
Affiliation  TATA MEMORIAL CENTRE 
Address  Department of Anaesthesia, 2nd floor, main building, major OR complex, Tata Memorial Hospital, Ernest Borges Rd, Parel,400012, Mumbai
Department of Anaesthesia, 2nd floor, main building, major OR complex, Tata Memorial Hospital, Ernest Borges Rd, Parel,400012, Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre, Mumbai 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  TATA MEMORIAL HOSPITAL, ERNEST BORGES RD, PAREL, 400012, MUMBAI 
Type of Sponsor  Research institution and hospital 
 
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 
Reshma Ambulkar  TATA MEMORIAL CENTRE  Ernest Borges Rd, Parel, 400012, Mumbai
Mumbai
MAHARASHTRA 
9821790448

rambulkar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C229||Malignant neoplasm of liver, not specified as primary or secondary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control arm  All participants will undergo a regular preoperative at least single group physiotherapy teaching session, After that patients are asked to do the same exercises daily at their homes.  
Intervention  Interventional arm  prescribed exercise program for a period of five weeks. Patients allocated to the intervention arm, will first undergo one week of exercise training at hospital, followed by four weeks of indivualised home based exercise program under the guidance of the physiotherapist. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All Patients with age between 25-80 years [11] planned for major hepatic (≥3 segments) or pancreatic resection  
 
ExclusionCriteria 
Details  1. Patients requiring neoadjuvant chemotherapy
2. Any condition that prevents patients from undergoing regular exercises- locomotor limitations precluding exercise training adherence to the program.
3. Known case of COPD and platelet count of Ë‚ 80,000 [12]
4. Restricts patients to undergo a CPET evaluation: grade ≥3 peripheral neuropathy, a recent history (within the previous 3 months) of myocardial infarction or unstable angina, cerebrovascular event or transient ischemic attack or pulmonary embolic event, or existing acute or chronic deep vein thrombosis, or active sepsis.
5. Cognitive deterioration preventing adherence to the program
6. Requiring expedited surgical procedures (<5weeks time from day of decision of surgery to intended date of surgery)
7. Hemoglobin <8mg/dl
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A Change in AT (Anaerobic threshold) and VO2max by 2.
 
4 WEEKS
 
 
Secondary Outcome  
Outcome  TimePoints 

1.Morbidity: Total incidence of postoperative complications within the first 30 days after surgery assessed by Clavien-Dindo grading system
2.Change in 6MWT
3.Incidence of Post op pulmonary complications
4.Length of ICU/HDU stay
5.Total length of hospital stay
6.30 days mortality
7.Post operative complications incidence subdivided into minor and Major
 
4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/01/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hepatic and pancreatic resection surgeries are the standard of care for patients with primary or secondary hepatic and pancreatic tumours. Management of these cancers typically involves aggressive, lengthy procedures with locoregional with or without systemic therapy. Combination of these treatments can lead to a plethora of acute and long-term toxic effects that can, in turn, lead not only to considerable functional morbidity but also to an increased risk of mortality [1,2]. Cancer and its treatments related deconditioning is a serious problem. That is why physical activity recommendations for cancer patients has begun to change. 

      Previous studies have shown that though there is a declining trend of mortality post major abdominal surgeries, the morbidity rates are still high, ranging from Pancreas – Mortality – 1.7%, Major Morbidity – 30%, Liver – Mortality – 3.8%, major Morbidity 19% (Our Hospital data). Studies have been done in the past, highlighting the role of prehabilitation in reducing postoperative complications [3,4]. Nevertheless, the precise protocol of prehabilitation has not been completely established [5,6]. Further work is required to tailor optimal prehabilitation protocols for specific operative procedures.

     Cancer-related fatigue is a well-known side effect of anti-cancer therapies. Exercise interventions have been developed to prevent or counteract fatigue with promising results [7,8]. Thus, we have planned a prehabilitation programme for patients requiring major hepatic (≥3 segment liver resection) and pancreatic resections which includes a structured home-based individualized exercise training.

     Though in our institute currently we are following a prehabilitation programme which also includes a single session of supervised exercise training followed by unsupervised and unmonitored exercise prescription at home. Our hypothesis is that a more structured (more supervised and monitored) individualised exercise prescription-based program may further help in prehabilitation which will improve functional capacity resulting in decrease in the postoperative morbidity and mortality. However, such a program needs to be evaluated for its feasibility and effectiveness in patients undergoing hepatic and pancreatic resection surgeries.

 
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