| CTRI Number |
CTRI/2019/01/016841 [Registered on: 02/01/2019] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Checking Effectiveness of a protocol in improving movement of patients in Medical Intensive Care Unit |
|
Scientific Title of Study
|
Effectiveness Of Structured Early Mobilization Protocol On Mobility Status Of Patients In Medical Intensive Care Unit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gatty Aishwarya Prabhakar |
| Designation |
Post Graduate student |
| Affiliation |
Kasturba Medical College, Mangaluru |
| Address |
Kasturba Medical College Center for Basic Sciences,
Department of Physiotherapy, Bejai, Mangaluru
Dakshin Kannada
Karnataka
India
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8971846776 |
| Fax |
|
| Email |
ashgatty95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Gopala Krishna |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangaluru |
| Address |
Kasturba Medical College Center for Basic Sciences,
Department of Physiotherapy, Bejai, Mangaluru
Dakshin Kannada
Karnataka
India
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8971846776 |
| Fax |
|
| Email |
gopalalaparthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gatty Aishwarya Prabhakar |
| Designation |
Post Graduate student |
| Affiliation |
Kasturba Medical College, Mangaluru |
| Address |
Kasturba Medical College Center for Basic Sciences,
Department of Physiotherapy, Bejai, Mangaluru
Dakshin Kannada
Karnataka
India
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8971846776 |
| Fax |
|
| Email |
ashgatty95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Madhav Nagar, Manipal |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gatty Aishwarya Prabhakar |
Kasturba Medical College Hospitals |
Intensive care unit
Jyothi circle and Attavar
Mangaluru
Dakshina Kannada
KARNATAKA |
8971846776
ashgatty95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Medical College, Mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F||Physical Rehabilitation and Diagnostic Audiology, (2) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Early Mobilization according to the usual care |
| Intervention |
Intervention Group |
Early mobilization according to the protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in ICU who are referred for physiotherapy by physician or intensivist
2. Age >18 years of age
3. Both the genders
4. Patients who are mechanically and non-mechanically ventilated |
|
| ExclusionCriteria |
| Details |
1. Unstable fractures or any other injuries which require medical bed rest
2. Patients with hemodynamic instability (HR <50 or >140 bpm , SBP <80 or >180 mm Hg, MAP <60 or >110 mm Hg)
3. Richmond Agitation-Sedation Scale +3 or +4
4. Patients who have undergone recent surgeries
5. Patients with deep Vein Thrombosis
6. Cardiopulmonary arrest at admission or during the ICU stay |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient Mobility measured by Perme Intensive Care Unit Scale |
Everyday after intervention till ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of ventilated days
2.Length Of ICU Stay |
1.After removal from the ventilator
2.Shift out from the ICU |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/01/2019 |
| Date of Study Completion (India) |
17/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published
Gatty A, Samuel SR, Alaparthi GK, Prabhu D, Upadya M, Krishnan S, Amaravadi SK. Effectiveness of structured early mobilization protocol on mobility status of patients in medical intensive care unit. Physiother Theor Pract. 2022;38(10):1345-57. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Patients referred for physiotherapy by the intensivist or physician will be screened based on the inclusion and exclusion criteria and those who meet the inclusion criteria will be recruited for the study after getting informed consent from the patient or patient party. Demographic and baseline data of all the patients will be noted on day one. The data includes vitals clinical diagnosis, co-morbidities, medication in use, severity of disease analysis of patients by means of the APACHE II score, Richmond Agitation Sedation scale, the Glasgow coma scale(for patients without sedation), type of ventilation. The Perme ICU mobility score will be taken prior to the commencement of mobilization. Based on the intensivist and a senior expert physiotherapist’s discretion, patients will receive early mobilization as per structured protocol or as per usual practice in MICU for 5-7 days a a week. The primary investigator will score the patients on Perme ICU mobility score post mobilization for each subsequent day till the ICU stay. Reasons for discontinuation of any session will also be collected. Number of ventilated days and length of ICU stay will be recorded. Data will be recordeed and statistical analysis will be done and the results be provided. |