FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/085420 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Mobilization Improve the Outcomes in ICU patients 
Scientific Title of Study   Effects pf Early mobilization on outcomes in ICU patients: A Prospective observational 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  Dr Santosh Rajput 
Designation  Senior Resident (Academics)- Critical Care Medicine 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  CCU level 6, Department of Anesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh, Dehradun UTTARANCHAL 249203 India

Dehradun
UTTARANCHAL
249203
India 
Phone  7489970985  
Fax    
Email  santoshrajput.edu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankit Agarwal 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  CCU level 6, Department of Anesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh, Dehradun UTTARANCHAL 249203 India

Dehradun
UTTARANCHAL
249203
India 
Phone  9761966555  
Fax    
Email  ankit.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Ankit Agarwal 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  CCU level 6, Department of Anesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh, Dehradun UTTARANCHAL 249203 India

Dehradun
UTTARANCHAL
249203
India 
Phone  9761966555  
Fax    
Email  ankit.anaes@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Level-6, Veerbhadra Road, AIIMS Rishikesh, Dist- Dehradun, Uttarakhand, India. PINCODE- 249203 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Department of Anesthesiology, Level-6, Veerbhadra Road, AIIMS Rishikesh, Dist- Dehradun, Uttarakhand, India. PINCODE- 249203 
Type of Sponsor  Government medical college 
 
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 Santosh Rajput  AIIMS Rishikesh  Critical Care Unit ,level 6, Block B,Department of Anesthesiology, AllIndia Institute of Medical Sciences,Rishikesh Dehradun UTTARANCHAL
Dehradun
UTTARANCHAL 		 7489970985

santoshrajput.edu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparing the effects of early mobilization with conventional mobilization in critically ill patients.  Early mobilization include the mobilization within 72 hours of ICU admission. Conventional include 72 hours after ICU admission. We hypothesize that early mobilization will prevent muscles wasting, functional impairment and insulin resistance and may lead to early discharge from ICU. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age more than 18 years, of either gender,
2.Critically ill patients
3. NIV (Non Invasive ventilation) requirement
4. fully conscious 
 
ExclusionCriteria 
Details  1. Low level sensorium
2. Hemodynamically unstable
3. Administration of a new pressor
4. New Mycardial infraction
5. Invasive mechanical ventilation.
6. unstable spinal cord injury or head injury.
7. lower limb deformities or unstable fracture


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the length of ICU stays in early mobilised patients.
 		 To evaluate the length of ICU stays in early mobilised patients at hospital discharge.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate ambulatory dependence at hospital discharge in early mobilized patients.
2.To assess ventilator-free days, hospital stay, & the need for repeated intubation in patients post-extubation.
 		 Comparing from baseline, at 2 week & at hospital discharge 
 
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)   05/05/2025 
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 Yet Recruiting 
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
  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
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [santoshrajput.edu@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   After written informed consent, patients meeting the study criteria will be enrolled. following data will be collected: patient demographic, medical history, premorbid level of function, activity and excercise response, primary diagnosis, medications, risk factors and lifestyle conditions. in ICU, residents and nursing officers will carry out mobilization and rehabilitation with a nurse to patient ratio of 1:2. early mobilization  will be defiend as initiating rehabilitation, including sitting on the edge of the bed or more, within the first 3 days of ICU admission. active rehabilitation will encompass activities such as sitting out of bed, transferring to a chair, standing, marching and ambulating. Length of ICU stay will be compared in early mobilized and conventional mobilization patients.  
Close