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
|
|
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
|
|
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 speciï¬c 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. |