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CTRI Number  CTRI/2024/06/069472 [Registered on: 25/06/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of pre-operative exercise training in esophageal cancer surgeries 
Scientific Title of Study   Effect of pre-operative exercise training in resectable esophageal cancer- a feasibility study 
Trial Acronym  Prehabilitation study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manali Kamat 
Designation  Scientific Assistant "E"(Physiotherapy) 
Affiliation  Tata Memorial Hospital 
Address  Physiotherapy department, Tata Memorial Hospital, Main building, room no.96 Dr. E. Borges Marg, Parel, Mumbai- 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224174137  
Fax    
Email  manalikamat11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manali Kamat 
Designation  Scientific Assistant "E"(Physiotherapy) 
Affiliation  Tata Memorial Hospital 
Address  Physiotherapy department, Tata Memorial Hospital, Main building, room no.96 Dr. E. Borges Marg, Parel, Mumbai- 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224174137  
Fax    
Email  manalikamat11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manali Kamat 
Designation  Scientific Assistant "E"(Physiotherapy) 
Affiliation  Tata Memorial Hospital 
Address  Physiotherapy department, Tata Memorial Hospital, Main building, room no.96 Dr. E. Borges Marg, Parel, Mumbai- 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224174137  
Fax    
Email  manalikamat11@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr. E. Borges Marg, Parel, Mumbai- 400012,Maharashtra,India 
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 
Manali Kamat  Tata Memorial Hospital  Physiotherapy department, Tata Memorial Hospital,main building- room no.96, Dr. E. Borges Marg, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA 		 02224174137

manalikamat11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention group  After all the preliminary physical evaluations participants will be engaged in supervised exercise training under qualified Physiotherapist. This training will be given in the Physiotherapy department under controlled conditions for at least three days in a week for 12 to 14 sessions. Resistance exercises will target the major muscle groups for upper and lower limbs using resistance band participants will do at least 8-10 repetitions of minimum 1 to 2 sets with 2-3 minutes of rest interval between the sets for two to three times in a week. Pre and post vital parameters and Rate of perceived exertion (RPE) will be checked in every session.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  participants with age 18 years and above, able to read, and medically fit to undergo exercise trial 
 
ExclusionCriteria 
Details  participants with age 80 and above, with any neurological, orthopedic condition that hamper to undergo exercise training, and with advanced disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To check the feasibility and adherence to supervised exercise training in pre-operative stage.  All outcomes will be assessed at pre-treatment (before intervention), after 12 to 14 sessions of intervention, post operatively between (7 to 10 days) before discharge. Feasibility will be recorded in terms of lost to follow up, attended number of sessions, permanent discontinuation of training, treatment interruption (miss≥ 3 consecutive sessions) 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of preoperative exercise training on postoperative complications on the basis of Clavein-Dindo classification and length of stay in the hospital.
To assess the effect of supervised exercise training on 6-minute walk distance.
To assess Quality of life by EORTC QLQ EOS-18 and EORTC-C30
 		 4 to 6 weeks before surgery and post-operatively before discharge from the hospital. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 3 
Date of First Enrollment (India)   16/07/2024 
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="2"
Months="0"
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   The need for this study to evaluate the feasibility of supervised exercises for operable esophageal cancers and its effect on functional status. Patients will be evaluated before starting of any cancer treatment, after exercise intervention completion and post-operatively before discharge. All adults of any age diagnosed with esophageal cancer and planned for surgery and preoperative therapy, willing to give informed consent, willing to attend Physiotherapy department for exercises and who are fit to undertake mild to moderate exercise interventions will be included in the study. Patients with cognitive impairment, advanced disease, not able to complete baseline physical fitness test will be excluded. Physical fitness will be assessed on the basis of 6-minute walk test, grip strength, and spirometer while Quality of life will be measured by patient reported questionnaires such as EORTC QLQ-C-30 and EORTC QLQ-OES-18. (available in English, Hindi and Marathi)
After all the preliminary physical evaluations participants will be engaged in supervised exercise training under qualified Physiotherapist. This training will be given in the Physiotherapy department under controlled conditions for at least three days in a week for 12-14 sessions. Exercise session will include low intensity mixed type of exercises. Aerobic training will be given using active-passive trainer in the form of cycling while resistance exercises will be given using thera-tubing for both upper and lower limbs Pre and post vital parameters and Rate of perceived exertion (RPE) will be checked in every session. During rest of the day’s patients will be doing aerobic exercises in the form walking (on the basis of Borg rating of perceived exertion scale between 12-14) for at least 30 minutes as a home program along with conventional breathing exercises and spirometer. After supervised session home program will be given which includes walking and resistance training by using own body weight .Participants need to perform this exercises till surgery.
 
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