FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/064986 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Can physical function at discharge from hospital predict ability to carry out daily tasks in ICU survivors ? 
Scientific Title of Study   Does Physical Function at Hospital Discharge Predict Functional Recovery in ICU Survivors? 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anushka Raipure 
Designation  MPT Student 
Affiliation  Manipal Academy of Higher Education 
Address  Room number 308, Cardiopulmonary Rehabilitation Unit, Department of Physiotherapy, Third floor CTC Block, Kasturba Hospital, Udupi Hebri Road, Madhav Nagar, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9822307948  
Fax    
Email  anushka.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Mr Anup Bhat 
Designation  Assistant professor - selection grade 
Affiliation  Manipal Academy of Higher Education 
Address  Room number 308, Cardiopulmonary Rehabilitation Unit, Department of Physiotherapy, Third floor CTC Block, Kasturba Hospital, Udupi Hebri Road, Madhav Nagar, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9916820026  
Fax    
Email  anup.bhat@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Abraham Samuel Babu 
Designation  Associate professor 
Affiliation  Manipal Academy of Higher Education 
Address  Room number 308, Cardiopulmonary Rehabilitation Unit, Department of Physiotherapy, Third floor CTC Block, Kasturba Hospital, Udupi Hebri Road, Madhav Nagar, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9742502838  
Fax    
Email  abraham.babu@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, KARNATAKA, India 576104 
 
Primary Sponsor  
Name  Anushka Raipure 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India. 576104 
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 Vishal Shanbhag  Kasturba Hospital  Medicine Wards, Third floor, Baliga Block, Kasturba Hospital, Udupi Hebri Road, Madhav Nagar, Manipal.
Udupi
KARNATAKA 		 9901960496

vishal.shanbhag@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 ( Student Research )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G729||Myopathy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. ICU survivors (patients mechanically ventilated for at least 48 hours with an ICU length of stay of at least three days), getting discharged from the hospital.
2. Richmond Agitation-Sedation Scale (RASS) Score 0 and +1
3. MOCA scores 26 and above
 
 
ExclusionCriteria 
Details  1. Patients discharged from the hospital with palliative intent.
2. Patients requiring assistance/support for their activities of daily living prior to ICU admission.
3. Patients with fractures that require immobilization following hospital discharge.
4. Patients getting readmitted to the ICU during the follow up period. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. PaciFic Tool
2. Barthel Index
3. Lawton Brody Instrumental Activities of Daily Activities 		 1. Hospital Discharge
2. 30-day follow-up
3. 90-day follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   10/04/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Understanding the factors influencing return to pre-hospitalization functional level is critical for improving outcomes in intensive care unit (ICU) patients after discharge. The long-term impact of ICU stays on the ability to carry out daily activities is determined by various factors, including the severity of the disease, the duration of medical treatments, and the patient’s general health. Addressing these gaps concerning the relationship between physical function at hospital discharge and subsequent outcomes in ICU survivors is critical for developing rehabilitation methods. The study aims to assess functional recovery at one- and three-months post-discharge and explore the role of physical function at discharge as a predictor of whether ICU survivors achieve pre-hospitalization function status post hospital discharge.

 
Close