| CTRI Number |
CTRI/2024/03/063550 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Exercise ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
uses of exercises before tummy surgery in reducing the after surgery difficulty |
|
Scientific Title of Study
|
Effects of prehabilitation in abdominal surgeries to prevent postoperative complication |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J Komisharajam |
| Designation |
MPT Student |
| Affiliation |
Sri Ramachandra Institue of higher education and research |
| Address |
Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
8610854477 |
| Fax |
|
| Email |
komisha.j@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
prof N Venkatesh |
| Designation |
professor |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Third floor
faculty of physiotherapy
Sri Ramachandra Institute of Higher Education and Research
Porur
chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9444494821 |
| Fax |
|
| Email |
vnk646@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
prof N Venkatesh |
| Designation |
professor |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
third floor
faculty of physiotherapy
Sri Ramachandra Institute of Higher Education and Research
Porur
chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9444494821 |
| Fax |
|
| Email |
vnk646@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
J Komisharajam |
| Address |
Sri Ramachandra Institue of higher education and research porur chennai 600116 |
| Type of Sponsor |
Other [self ] |
|
|
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 |
| Dr J Komisharajam PT |
Sri Ramachandra Institute of Higher Education and Research |
2nd floor
Faculty of physiotherapy
Sri Ramachandra institute of higher education and research
porur chennai 600116
Chennai
TAMIL NADU |
08610854477
komisha.j@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Students Projects DHR/ICMR REG NO EC/NEW/INST/2023/TN/0321 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R109||Unspecified abdominal pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
education |
education about the preoperative physiotherapy
(booklets) |
| Intervention |
preoperative physiotherapy |
preoperative exercise including inspiratory muscle training resistance exercise AROM exercise mobilization of 6 to 8 session each session of 20 to 30 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60
consent participants
Planned abdominal surgeries |
|
| ExclusionCriteria |
| Details |
Emergency abdominal surgeries
Carcinoma abdominal surgery
Mental condition
Neuromuscular condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Melbourne scale
6 minute walk test
Length of stay |
following the surgery and before the discharge of patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
GPAQ
WHOQOL BREF |
to assess the quality of living & its effects postoperative period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/03/2024 |
| 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="0"
Months="6"
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
|
The study title is Effects of prehabilitation in abdominal surgeries to prevent postoperative pulmonary complication In this study the volunteer participants are randomised into study group and control group of the participants meet the inclusion criteria The study group will receive 6 to 8 session of preoperative physiotherapy whereas the control group receive a single session of booklet and education about prehabilitation And both the group will receive the standard postoperative care the outcome like occurrence of pulmonary complication, functional status and length of stay are taken |