| CTRI Number |
CTRI/2025/10/096710 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA)
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on How Moving Patients Early During Serious Illness, Compared to Regular ICU Care, Helps Them Recover Strength and Function, and Prevents Muscle Loss. |
|
Scientific Title of Study
|
Effect Of Protocolised Early Mobilisation Versus Routine Icu Care On Functional Outcome And Sarcopenia In Critically Ill Patients - A Prospective Randomised Control 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 |
Abhijith S |
| Designation |
Senior resident in critical care medicine |
| Affiliation |
Jubilee mission medical college and research institute |
| Address |
Department of critical care medicine
Jubilee mission medical college and research institute
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
8136872763 |
| Fax |
|
| Email |
drabhijiths@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr John Paul |
| Designation |
Assosiate professor in critical care medicine |
| Affiliation |
Jubilee mission medical college and research institute |
| Address |
Department of critical care medicine
Jubilee mission medical college and research institute
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9447991902 |
| Fax |
|
| Email |
drpauljohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijith S |
| Designation |
Senior resident in critical care medicine |
| Affiliation |
Jubilee mission medical college and research institute |
| Address |
Department of critical care medicine
Jubilee mission medical college and research institute
Thrissur
KERALA
680005
India |
| Phone |
8136872763 |
| Fax |
|
| Email |
drabhijiths@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jubilee mission medical college and research institute, Thrissur, Kerala, India
PIN - 680005 |
|
|
Primary Sponsor
|
| Name |
Abhijith S |
| Address |
Department of critical care medicine
Jubilee mission medical college
Jubilee mission PO
Thrissur
680005 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Abhijith S |
Jubilee mission medical college and research institute |
Advanced critical care unit
Department of critical care medicine
Thrissur
KERALA |
8136872763
drabhijiths@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee at Jubilee Mission medical College and Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Protocolised mobilisation |
Mobilisation will be initiated within 48 hours of ICU admission, and progressed stepwise according to patient’s clinical status and tolerance
Level I (Unconscious patients): Passive range of motion exercises 2 times per day, 6 hourly turning
Level II (Conscious, minimal strength): Active-assisted and resistance physiotherapy, sitting upright for more than or equal to 20 minutes, 2 times per day
Level III(Conscious, UL Power more than 3 out of 5): Sitting at edge of bed, progressive resistance training, supported standing
Level IV(Conscious, LL Power more than 3 out of 5): Active transfer to chair, out-of-bed mobilisation, ambulation with assistance.
|
| Comparator Agent |
Routine icu care |
Patients will receive limb physiotherapy and mobilisation as deemed appropriate by the treating physician. No structured protocol will be followed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ICU patients who are expected to stay in ICU for more than 48 hours and able to initiate mobilization within 48 hours of ICU admission |
|
| ExclusionCriteria |
| Details |
Hemodynamic instability, requiring more than 0.8mcg per hour of noradrenaline or comparable inotropic support, severe pulmonary hypertension, bradycardia requiring treatment or dependent rhythm with pacemaker, tachyarrhythmia ventricular rate more than 120 beats per minute, cardiac ischemia
Fio2 requirement more than 60 percent , PEEP more than 10 , prone positioning
Polytrauma with traumatic brain injury with risk of raised intracranial pressure , unstable spine injuries, unstable pelvis or long bone fractures, blunt or open trauma chest and abdomen with active bleeding risk
Active neurological concern , RASS score other than -2 to +1, active management of elevated intracranial pressure, uncontrollable seizures
Patients with devices such as Femoral IABP or ECMO or pulmonary artery catheter or another cardiac monitoring device or femoral sheaths
Previously bedridden patients or pre-existing neuromuscular disease or severe physical disability
Any other contraindication to mobilisation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional status at ICU discharge: measured by ICU mobility scale
Change in rectus femoris muscle thickness and cross-sectional area
|
ICU mobility scale - at ICU admission and discharge from icu
Change in rectus femoris muscle thickness and cross-sectional area - at ICU admission, day 3, day 7 , day of discharge from ICU
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ICU length of stay
Ventilator free days
Complications related to mobilisation
|
ICU length of stay - at discharge from icu
Ventilator free days - at discharge from icu
Complications related to mobilisation - on each day during icu stay
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/11/2025 |
| 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="2"
Months="0"
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
|
This study is a randomised parallel group active controlled trial to determine whether protocolised early mobilization strategy improves functional outcome and reduces sarcopenia in critically ill patients compared to routine ICU care that will be conducted in department of critical care medicine in Jubilee mission medical college and research institute. The primary outcome will be to determine functional outcome by assessing ICU Mobility score at time of discharge from ICU and to compare rectus femoris thickness and cross sectional area measured with bedside USG at admission and time of discharge from ICU. The secondary outcomes will be to measure length of stay in ICU, ventilator free days and complications during mobilisation.
|