| CTRI Number |
CTRI/2021/05/033707 [Registered on: 20/05/2021] Trial Registered Prospectively |
| Last Modified On: |
06/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To observe the difference of exercises given in presurgical period on patients undergoing major abdominal surgery. |
|
Scientific Title of Study
|
Effectiveness Of Prehabilitation on patients opting for elective abdominal surgeries : A pre-post study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jean Nikitha Noronha |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College,Mangalore |
| Address |
Department Of Physiotherapy , Kasturba Medical College Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9082582934 |
| Fax |
|
| Email |
jeannikitha15.11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Stephen Rajan Samuel |
| Designation |
Assistant Professor-Senior Scale |
| Affiliation |
Kasturba Medical College,Mangalore |
| Address |
Department Of Physiotherapy , Kasturba Medical College Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9901539145 |
| Fax |
|
| Email |
stephen.samuel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Stephen Rajan Samuel |
| Designation |
Assistant Professor-Senior Scale |
| Affiliation |
Kasturba Medical College,Mangalore |
| Address |
Department Of Physiotherapy , Kasturba Medical College Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9901539145 |
| Fax |
|
| Email |
stephen.samuel@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal University
KMC,mangalore |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Light house hill road, 575001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Jean Nikitha Noronha |
KMC Mangalore |
Department Of Physiotherapy , Kasturba Medical College Mangalore
Dakshina Kannada
KARNATAKA |
9082582934
jeannikitha15.11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Prehabilitation Exercise Programme |
Prehabilitation Exercise Programme includes General Aerobic exercises , Chest physiotherapy ( breathing exercises ) and other exercises as indicated.
3-7 days before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of either gender scheduled for elective open abdominal surgery.
2.Age group: adults 18+ and above
|
|
| ExclusionCriteria |
| Details |
1.Patients undergoing high-risk / emergency / laparoscopic abdominal surgeries
2.Any Musculoskeletal or neurological condition that will impair the patient ability to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility |
On the day of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Respiratory muscle strength
2.Six Minute Walk Test
3.WHOQOL-BREF
|
Baseline and post surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/05/2021 |
| Date of Study Completion (India) |
01/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction- Prehabilitation, with its first published article in 1946, is an intervention of
conditioning a patient in the pre-surgical period to be able to cope with the post-surgery
stressors. It is a concept that is defined as a wide group of interventions that prepares a patient before major surgery and also at the same time aims at reducing pre-operative complications,
promotes physical activity, and also optimizes their psychological wellbeing. The purpose of rehabilitation before major surgery is to maintain the normal levels of functionality and also to attain a faster recovery of the functional status during post-op inactivity. It signifies a change from the impairment driven, reactive model of care towards an active approach that
allows a patient to become an active participant in their care. Feasibility is the practicality of a study and how many people are willing .
Feasibility studies are pieces of research done before the main study to answer questions about whether an intervention is appropriate for further testing i.e. they enable researchers to judge
whether or not the ideas and findings can be shaped to be relevant and sustainable study. The procedure of this study - Patients scheduled for Elective Open Abdominal surgery that will be referred for physiotherapy treatment will be recruited through the clinical co-guide. The patients recruited will be screened for inclusion and exclusion criteria. The patients who meet the criteria will be
explained about the study. After the explanation, if the patient agrees to participate consent form will be signed and permission will be taken. and after consent was taken will be included in the study. This group will be included in the interventional group. Baseline values will be noted at the beginning of the study. An Exercise The brochure will be given to the intervention group and also a one-time demonstration of the exercises will be shown to the participants. Exercise Protocol will contain Aerobic exercises i.e., walking, 30min/day at least 5times in a week (according to his level of comfort). Breathing exercises that will include Patient Education, Active Cycle of
Breathing Techniques (ACBT), Thoracic Expansion Exercises (TEE), Forced
Expiration Technique (FET), Breathing Control Twice / per day 10-15 min. Any Other
Chest Physiotherapy as indicated. Progression will according to the patient’s rate of perceived exertion (RPE).
And also, the possible post-operative complications that can develop post-surgery
Educating about smoking cessation, proper nutrition (in case the patient has any
other comorbidities)
The participants will be given a diary / will be telephone called (and the calls
will be recorded for proof upon receiving permission from the patient ) on alternate
days by the tester to make updates, note changes, progress with the exercises depending
on the patient’s RPE any difficulties noted by the patient. Outcomes measure will once again be taken before surgery and
postoperatively on the day of discharge.
Post-op physiotherapy will continue routine protocol including incentive
spirometry and ACBT. |