FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/12/038744 [Registered on: 20/12/2021] Trial Registered Prospectively
Last Modified On: 02/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trail to study various effects of inspiratory muscles training 
Scientific Title of Study   Effects of inspiratory muscles training in exploratory laparotomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashish Gupta PT 
Designation  Associate Professor 
Affiliation  K M Patel Institute of Physiotherapy 
Address  152,Department of K M Patel institute of Physiotherapy, Shree Krishna Hospital, Karamsad
D3/28, staff quarter, shree Krishna hospital , gokal nagar, Karamsad.
Anand
GUJARAT
388325
India 
Phone  9925048223  
Fax    
Email  ashishvg@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Shweta Parikh PT 
Designation  Associate professor 
Affiliation  K M Patel Institute of Physiotherapy  
Address  152,Department of K M Patel institute of Physiotherapy, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  9427083406  
Fax    
Email  shwetap@charutarhealth.org  
 
Details of Contact Person
Public Query  
Name  Vedika Upadhyay 
Designation  MPT student  
Affiliation  K M Patel Institute of Physiotherapy 
Address  152,Department of K M Patel institute of Physiotherapy, Shree Krishna Hospital, Karamsad
"Gayatri Krupa" B/H SBI, Bhatiel, Ta- Petlad 388450
Anand
GUJARAT
388450
India 
Phone  8511849900  
Fax    
Email  vedikapu@charutarhealth.org  
 
Source of Monetary or Material Support  
K. M. Patel Institute of Physiotherapy 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [None] 
 
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 Ashishkumar Gupta   K, M, Patel Institute of Physiotherapy   152,Department of K M Patel institute of Physiotherapy, Shree Krishna Hospital, Karamsad
Anand
GUJARAT 		 9925048223

ashishvg@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaikaka University, Karamsad, Anand, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  conventional group   conventional group will receive treatment according to conventional protocol as per need of the participant. It will include chest physiotherapy including incentive spirometry, general mobility & mobilization upto discharge from hospital. 
Intervention  Inspiratory Muscles Training   Inspiratory Muscle training will be given to participants of interventional group along with conventional training. Doses of IMT will be 30% of MIP, 3 sets of 10 repetitions with needed pause, thrice daily upto discharge from hospital. every day 2 gradation will be increased. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Referred by surgeon who have underwent exploratory laparotomy
2) more than 18 years of age
3) After 48 hours in case of uneventful surgery or after extubation in case of ventilator support needed
4) Conscious and weaned from ventilator.
 
 
ExclusionCriteria 
Details 
1) Participants who cannot comprehend instructions
2) Participants who are intubated
3) Underlying complicated conditions (e.g., open wound, burst abdomen, infection at incision site) which may not allow for IMT
4) if 2nd surgery needed to be done within intervention period.

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Maximal Inspiratory Pressure   On day of intervention,
On day of discharge from hospital,
On day of 1st follow up  
 
Secondary Outcome  
Outcome  TimePoints 
1) Chest Expansion
2) 6 Minute Walk Test
3) De Morton mobility Index 		 1) On day of intervention, On day of discharge from hospital & On day of 1st follow up
2) On day of discharge from hospital
3) On day of intervention, On day of discharge from hospital & On day of 1st follow up 
 
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)   24/12/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   nil  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   After signing consent form, participant will be randomly divided into Group A (Conventional group ) & Group B (Interventional group). Group A will receive intervention according to conventional protocol as per the need of the participants( chest physiotherapy including spirometry, general mobility & mobilization up to discharge from hospital). Group B will receive additionally Inspiratory muscle training via IMT device along with conventional protocol. Protocol for IMT will be 30% of MIP, 3 sets of 10 repetition with pause needed, thrice daily up to discharge from hospital. During training, separate mouth piece will be used for each candidate & after the use of IMT device, ETO of the device will be done to minimize chances of cross infection. 
Close