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CTRI Number  CTRI/2025/04/085805 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [open abdominal surgery]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Additive Effect Of Inspiratory Muscle Training On Respiratory Muscle Strength, Single Breath Count And Kinesiophobia In Patients With Open Abdominal Surgery- An Experimental Study. 
Scientific Title of Study   Additive Effect Of Inspiratory Muscle Training On Respiratory Muscle Strength, Single Breath Count And Kinesiophobia In Patients With Open Abdominal Surgery- An Experimental Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Achal Lathi 
Designation  MPT 1 
Affiliation  SMT. KASHIBAI NAVALE COLLEGE OF PHYSIOTHERAPY 
Address  S.NO 48,55,1, 48,56,1, Off esterly bypass narhe, pune 411041 Smt. kashibai navale college of physiotherapy

Pune
MAHARASHTRA
411041
India 
Phone  7972404450  
Fax    
Email  draachallathi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ketki Ponde 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SMT. KASHIBAI NAVALE COLLEGE OF PHYSIOTHERAPY 
Address  S.NO 48,55,1, 48,56,1, Off esterly bypass narhe, pune 411041 Smt. kashibai navale college of physiotherapy

Pune
MAHARASHTRA
411041
India 
Phone  9890993197  
Fax    
Email  Ketkiponde.skncopt@sinhgad.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ketki Ponde 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SMT. KASHIBAI NAVALE COLLEGE OF PHYSIOTHERAPY 
Address  S.NO 48,55,1, 48,56,1, Off esterly bypass narhe, pune 411041 Smt. kashibai navale college of physiotherapy

Pune
MAHARASHTRA
411041
India 
Phone  9890993197  
Fax    
Email  Ketkiponde.skncopt@sinhgad.edu  
 
Source of Monetary or Material Support  
S.NO 48,55,1, 48,56,1, Off esterly bypass narhe, pune 411041 Smt. kashibai navale college of physiotherapy  
 
Primary Sponsor  
Name  Achal Lathi  
Address  S.NO 48,55,1, 48,56,1, Off esterly bypass narhe, pune 411041 Smt. kashibai navale college of physiotherapy  
Type of Sponsor  Other [Charitable 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 
Dr Ketki Ponde  SMT. KASHIBAI NAVALE COLLEGE OF PHYSIOTHERAPY  S.NO 48,55,1, 48,56,1, Off esterly bypass narhe, pune 411041 Smt. kashibai navale college of physiotherapy
Pune
MAHARASHTRA 		 9890993197

Ketkiponde.skncopt@sinhgad.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Of Smt. Kashibai Navale College Of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional physiotherapy  1) Breathing Exercise 5-7 repetitions will be given: a) Diaphragmatic Breathing Exercise b) Thoracic Expansion Exercise c) lateral costal expansion technique 2) Upper Limb (UL) & Lower Limb (LL) mobility exercise – 10 reps 1set 3) Ambulation. 4) Incentive spirometer 10 reps.  
Intervention  Inspiratory Muscle Training and conventional physiotherapy  The participants will be in sitting position. The participants will be instructed to close their lips over the mouthpiece and inhale deeply, then continue to inhale and exhale without taking the device out of their mouth. The participants will begin training with a light load, The training load is increased to 30% of the initial PImax. The duration of the training will be 25–30min each time, 3set of 5repetation with 2min rest, twice a day, for Six days per week for at least one weeks. conventional pt 1) Breathing Exercise 5-7 repetations will be given: a) Diaphragmatic Breathing Exercise b) Thoracic Expansion Exercise c) lateral costal expansion technique 2) Upper Limb (UL) & Lower Limb (LL) mobility exercise – 10 reps 1set 3) Ambulation 4)Incentive spirometer 10 rep  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age 20-60 years.
2. Males and female who have undergone open abdominal surgery.
3. Patients vitally stable.
4. Able to follow command.
5. Pain less than 5 on Numerical pain rating scale.
 
 
ExclusionCriteria 
Details  1. Any cognitive impairment.
2. History of prior abdominal surgery.
3. Patients with underlying pulmonary condition (Tuberculosis, rib fracture) cardiac conditions (Recent MI, ejection fraction less than 30%).
4. Patients on mechanical ventilator.
5. Patients with neurological deficit.
6. Patient with Pfannenstiel, lanz incisions.
7. Laproscopic surgery.
 
 
Method of Generating Random Sequence    
Method of Concealment   Other 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Respiratory Muscle Strength , Single Breath Count and Kinesiophobia  Respiratory Muscle Strength 1 day before surgery and post operation day 2nd and 6th , Single Breath Count and Kinesiophobia will be asses on post operative day 2nd and 6th. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/05/2025 
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="1"
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  
  • Approval will be taken from Principal, the Institutional Ethical committee and respective unit head of surgery department and HOD of surgery department. Participants will be screened as per the inclusion and exclusion criteria. Aim, objectives & treatment procedure will be explained to the participants in there best possible language and consent will be taken. Participants will be selected by means of purposive sampling and allocation will be done by chit method in Group A (Intervention group) and Group B (Control group). Pre & post data will be collected on prior day of operation, POD 2nd,and  6th day , Respiratory strength will be measure by maximum inspiratory pressure by pressure manometer, Single breath count test & Kinesiophobia will be assessed. ·     MIP will be determined by measuring the upper airway pressure during maximum voluntary inspiration using Micro RPM.

    ·     The MicroRPM is a small, portable, lightweight, noninvasive, mouth-pressure manometer with a rubber-flanged mouthpiece. The MicroRPM displays the test results in a device monitor, uses software and calculates the MIP values, in cmH2O, from the one-second average maximum pressure

    ·     According to the guidelines of the American Thoracic Society (ATS)/European Respiratory Society (ERS).

    ·     During the MIP measurement the participant will be asked to hold the gauge with both hands and to close his or her lips firmly around the flanged mouthpiece.

    ·     We applied a nose clip to avoid nasal air leak.

    ·     For the MIP maneuver the participant will be asked to exhale as much as possible (to residual volume) and then to inhale maximally for more than one second against the resistance of the gauge.

    ·     The measurements are repeated 3 times, taking the maximum value as a record.

     

    1)      Single Breath Count (ICC=0.976)

    ·     The participants will be asked to take a deep breath and count as far as possible in their normal speaking voice in a single inspiration without taking another breath while exhaling.

    ·     The participant will start counting from number 1 till the next inhalation.

    ·     Three attempts will be performed & recorded.

    ·     The best performance will be considered for final data analysis.

    ·     One minute rest will be provided between the consecutive performances.

     

    2)      Tampa scale of Kinesiophobia -11 (TSK-11) (ICC=0.93)

     

    •    A study by Woby for properties of the TSK-11 stated to evaluate movement/reinjury-related pain-related fear, the TSK-11 scale has been used.[13]   

    •    Response items are related to physical feelings (for example, “pain always means I’ve injured my body”) and activity avoidance (for example, “I’m afraid I’ll injure myself if I exercise”).

    •    TSK-11 scores range from 11 to 44, with higher scores indicating greater pain-related fear of movement/reinjury.

    •    On the TSK-11, the kinesiophobia categories are as follows:

    •    11–22 (minimum),

    •    23–28 (low),

    •    29–35 (moderate), and

    •    36–44 (high).
         Intervention will be started on Post operative day 2    nd    .Group A (interventional group) will receive Inspiratory Muscle Training with 30% of initial Pimax preoperative, 5repetation of 3set with 2min rest between the set for 6 days per week, twice a day for 1 weeks, along with Conventional physiotherapy.

    1) Breathing Exercise 5-7 repetations will be given:

          a) Diaphragmatic Breathing Exercise

          b) Thoracic Expansion Exercise

          c) lateral costal expansion technique

    2) Upper Limb (UL) & Lower Limb (LL) mobility exercise – 10 reps 1set

    3) Ambulation

    4)Incentive spirometer 10 rep

     6 days per week , 1 week , twice a day

    Group B (Control group): Will receive only conventional physiotherapy which includes

    1) Breathing Exercise 5-7 repetations will be given:

          a) Diaphragmatic Breathing Exercise

          b) Thoracic Expansion Exercise

          c) lateral costal expansion technique

    2) Upper Limb (UL) & Lower Limb (LL) mobility exercise – 10 reps 1set

    3)  Ambulation

  • 4)Incentive spirometer 10 rep

  • 6 days per week , 1 week , twice a day.

     

      Inspiratory muscle training will be given as below:

    1)The participants will be in sitting position.

    2)The participants will be instructed to close their lips over the mouthpiece and inhale deeply, then continue to inhale and exhale without taking the device out of their mouth.

    3)The participants will begin training with a light load, The training load is increased to 30% of the initial PImax.

    4)The Intensity will be increased by 5–10% per week. The duration of the training will be 25–30min each time, 3set of 5repetation with 2min rest, twice a day, for Six days per week for at least one weeks. 

 
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