| CTRI Number |
CTRI/2025/09/094506 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Physiotherapy Program After Robotic-Assisted Abdominal Surgery: A Feasibility Study |
|
Scientific Title of Study
|
A STRUCTURED MULTIMODAL PHYSIOTHERAPY PROTOCOL IN
POST ROBOTIC-ASSISSTED LAPROSCOPIC ABDOMINAL SURGERIES:
A FEASIBILITY STUDY |
| Trial Acronym |
SMART-RAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aathira Nair |
| Designation |
Post-Graduate Student |
| Affiliation |
KAHER Instittute of Physiotherapy |
| Address |
Advanced physiotherapy, KLE Dr Prabhakar Kore Hospital Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7276675973 |
| Fax |
|
| Email |
draathiranairpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Naik |
| Designation |
Associate Professor |
| Affiliation |
KAHER Instittute of Physiotherapy |
| Address |
Advanced physiotherapy, KLE Dr Prabhakar Kore Hospital Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
09986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Naik |
| Designation |
Associate Professor |
| Affiliation |
KAHER Instittute of Physiotherapy |
| Address |
Advanced physiotherapy, KLE Dr Prabhakar Kore Hospital Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
09986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and research center, Nehru Nagar, Belgavi, Karnataka, India, 590010 |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC campus,
Nehru nagar, Belgavi |
| 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 |
| Dr Aathira Nair |
KLE Dr. Prabhakar Kore Hospital |
Department of Cardiovascular and pulmonary Physiotherapy, Room no.6, KLE Hospital, JNMC Campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA |
07276675973
draathiranairpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLEU Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Structured Multimodal Protocol |
The participants will receive a Structured Multimodal Physiotherapy Protocol for three consecutive days following robotic-assisted laparoscopic abdominal surgery. The intervention will begin within 24 hours after surgery and include a combination of evidence-based physiotherapy techniques aimed at enhancing recovery and preventing post-operative complications.Intensity and progression of activities will be tailored to the patient’s tolerance, vital signs, and surgical recovery status, ensuring safety and feasibility throughout the 3-day period. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
1.Aged between 20-69 years of age of all genders 2.Patients undergoing elective Robotic-assisted laparoscopic abdominal surgeries
with expected duration more than 4 hours.
3.Subjects willing to participate. |
|
| ExclusionCriteria |
| Details |
1.Subjects undergoing open abdominal surgeries. - 2.Pre-existing history of asthma, chronic obstructive pulmonary disease (COPD), or other chronic lung conditions.
3.Subjects undergoing laparoscopic oncologic surgeries.
4.Mechanically ventilated patients after surge |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Respiratory capacity
1 Incentive Spirometry
2 Respiratory rate and oxygen saturation
3.Peak expiratory flow rate. |
Pre and post assessment will be taken. Pre- assessment will be taken before the session and post-assessment post session of each day for 3 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional capacity
1 Timed up & Go test
2 Fatigue Index |
Pre & post assessment will be taken. Pre- assessment will be taken before the session & post-assessment post session of each day for 3 days. |
Quality of Life
1.THE INTERNATIONAL PHYSICAL ACTIVITY
QUESTIONNAIRE (QOL Questionnaire) |
Pre and post assessment will be taken. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/10/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [draathiranairpt@gmail.com].
- For how long will this data be available start date provided 02-02-2026 and end date provided 02-02-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
OBJECTIVE - To determine the effect of structured multimodal physiotherapy protocol on respiratory capacity, functional capacity and quality of life using incentive spirometry, oxygen saturation, timed up and go test, fatigue index, International Physical Activity Questionnaire (IPAQ-QOL) in post robotic assisted laparoscopic abdominal surgeries.
INCLUSION CRITERIA: - Aged between 20-69 years of age of all genders.(5,6) - Patients undergoing elective Robotic-assisted laparoscopic abdominal surgeries
with expected duration more than 4 hours - Subjects willing to participate.
EXCLUSION CRITERIA: - Subjects undergoing open abdominal surgeries. - Pre-existing history of asthma, chronic obstructive pulmonary disease
(COPD), or other chronic lung conditions. - Subjects undergoing laparoscopic oncologic surgeries. - Mechanically ventilated patients after surgery.
OUTCOME MEASURES- RESPIRATORY CAPACITY- 1. INCENTIVE SPIROMETRY 2. RESPIRATORY RATE AND OXYGEN SATURATION 3.PEAK EXPIRATORY FLOW RATE
FUNCTIONAL CAPACITY - 1. TIMED UP AND GO TEST(TUGT) 2.FATIGUE INDEX
QUALITY OF LIFE 1. THE INTERNATIONAL PHYSICAL ACTIVITY
QUESTIONNAIRE (QOL Questionnaire) |