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CTRI Number  CTRI/2025/10/096542 [Registered on: 28/10/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   effect of arm exercise with and without deep breathing on oxygen levels in patient underwent upper abdomen surgeries. 
Scientific Title of Study   Immediate effects of upper extremity activities with and without deep breathing on oxygen saturation following upper abdominal surgeries.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAYOOJ M 
Designation  Post-Graduate Student 
Affiliation  Yenepoya Physiotherapy College 
Address  Yenepoya physiotherapy college, Physiotherapy Department, 6th floor,room number 603, Naringana campus, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9846511148  
Fax    
Email  sayoojm37@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  M R SIVAKUMAR 
Designation  Associate professor 
Affiliation  Yenepoya Physiotherapy College 
Address  Yenepoya physiotherapy college, Physiotherapy Department, 6th floor, staff room, Naringana campus, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448386457  
Fax    
Email  mrsivakumar@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  M R SIVAKUMAR 
Designation  Associate professor 
Affiliation  Yenepoya Physiotherapy College 
Address  Yenepoya physiotherapy college, Physiotherapy Department, 6th floor, staff room,Naringana campus, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448386457  
Fax    
Email  mrsivakumar@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Yenepoya (Deemed to be University), physiotherapy department, 6th floor; Street: University Road, Locality: Deralakatte, City: Mangalore, State: Karnataka, Postal Code: 575018, country: India 
 
Primary Sponsor  
Name  SAYOOJ M 
Address  Yenepoya physiotherapy college, Physiotherapy Department, 6th floor, Naringana campus, Mangaluru, Karnataka, pin code-575018, country- India 
Type of Sponsor  Other [self] 
 
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 
Dr M R SIVAKUMAR PT  Yenepoya Medical College Hospital  Surgery department, 6th floor, University road, Deralakatte, Mangaluru-575018, Karnataka, India
Dakshina Kannada
KARNATAKA 		 9448386457

mrsivakumar@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YENEPOYA ETHICS COMMITTEE-3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Upper limb exercise with deep breathing  Upper limb exercise include 5 set of 8 repetition bilateral flexion and extension of shoulder joint with elbow extended. At each set of flexion and extension, participants are also instructed to take deep breath during elevation of arm and to exhale while lowering the arm. 
Comparator Agent  Upper limb exercise without deep breathing  Upper limb exercise without deep breathing include 5 set of 8 repetition bilateral flexion and extension of shoulder joint with elbow extended. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects who underwent elective or emergency upper abdominal surgeries.
Subjects who are able to understand and follow verbal commands.
Cutt-off of SPO2 greather than or equal to 93 percentage
Age above 18years.
Patients in the early postoperative phase
 
 
ExclusionCriteria 
Details  Patients who experienced complications necessitating prolonged immobilization or intubation in the intensive care unit.
Severe complications like infections, respiratory failure, other critical illness which requires intensive care unit service.
Re-do surgeries.
Cognitive inabilities to perform exercises.
Patients who don’t have functional upper limb ROM, pain or other problems at bilateral or unilateral upper limb.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
oxygen saturation,
chest wall mobility 		 At baseline,
Post intervention (0 days) 
 
Secondary Outcome  
Outcome  TimePoints 
Pulse rate,
modified dyspnea score 		 At baseline,
Post intervention (0 days) 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/11/2025 
Date of Study Completion (India) 09/12/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  sayoojm37@gmail.com

  6. For how long will this data be available start date provided 02-01-2026 and end date provided 02-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

Abdominal surgeries are frequently performed to treat various health conditions, but they often lead to breathing-related problems after the operation, known as postoperative pulmonary complications (PPCs). These can slow recovery, extend hospital stays, and increase medical costs. Deep breathing exercises are already known to help improve lung function after such surgeries, but it’s still unclear whether adding simple upper limb movements can make a difference. This study aims to find out how upper extremity exercises, done with and without deep breathing, affect oxygen levels and chest movement right after surgery. Oxygen saturation, pulse rate, and chest expansion will be checked at different times during the exercises, and patients will also rate how hard it feels to breathe using the Modified Borg Dyspnea Scale.

 
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