| CTRI Number |
CTRI/2026/01/101449 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of early mobilization led by nurses in patients admitted to the intensive care unit. |
|
Scientific Title of Study
|
Effectiveness of Nurse-Led Early Mobilization in Improving Functional Recovery in ICU Patients: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAGARIKA PANDA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ims and sum hospital |
| Address |
IMS AND SUM HOSPITAL
Department of critical care medicine
1st floor,MICU-1
SOA UNIVERSITY
K-8 Kalinganagar
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8280097212 |
| Fax |
|
| Email |
sp.ruby@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAGARIKA PANDA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ims and sum hospital |
| Address |
IMS AND SUM HOSPITAL
SOA UNIVERSITY
K-8 KALINGANAGAR
BHUBANESWAR
Khordha
ORISSA
751003
India |
| Phone |
8280097212 |
| Fax |
|
| Email |
sp.ruby@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAGARIKA PANDA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ims and sum hospital |
| Address |
IMS AND SUM HOSPITAL
Department of Critical Care Medicine,1st floor ,MICU-1
SOA UNIVERSITY
K-8 Kalinganagar
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8280097212 |
| Fax |
|
| Email |
sp.ruby@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and Sum hospital
Department of critical care medicine
SOA university
k8,kalinganagar,ghatikia
Bhubaneswar
khorda
751003 |
|
|
Primary Sponsor
|
| Name |
IMS and SUM hospital |
| Address |
IMS and SUM hospital
Department of critical care medicine
SOA university
K8 Kalinganagar
Bhubaneswar
khorda
751003 |
| 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 |
| Sagarika panda |
IMS and SUM hospital |
Ims and Sum hospital
k-8 kalinganagar,ghatikia
Bhubaneswar
khorda
751030
Khordha
ORISSA |
8280097212
sp.ruby@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,IMS and Sum hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
routine ICU care including passive limb movements,posture changes and physiotherapy if prescribed.No structured nurse led mobilization protocol for 5 to 7 days. |
| Intervention |
structured nurse led mobilization in ICU patients |
Stepwise Mobilization Protocol
Frequency 2 to 3 sessions per day by trained nurses and physiotherapistand each session lasting 10-15 minutes as per the patient tolerance.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than or equal to 18 years.
2.ICU patients with mechanically ventilation or non-ventilated.
3.Hemodynamically stable which implies MAP more than or equal to 65 mmHg and no escalating vasopressors.
4.Expected ICU stay of more than 72 hours.
|
|
| ExclusionCriteria |
| Details |
1.Severe hemodynamic instability requiring high-dose vasopressors.
2.Active spinal precautions or recent spinal injury.
3.Therapeutic paralysis requiring neuromuscular blockade use.
5.Patients on extracorporeal membrane oxygenation
6.Pregnant patients.
7.Patients expected to die within 48 hours of ICU admission.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of nurse-led early mobilization on functional recovery at hospital discharge, measured using the Functional Independence Measure (FIM) |
At icu discharge (2wks) and hospital discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess improvements in:
Physical function at ICU discharge using the Physical Function ICU Test (PFIT-s).
Muscle strength using the Medical Research Council (MRC) sum score.
Exercise capacity using the Six-Minute Walk Test (6MWT) at hospital discharge.
ICU-acquired weakness (ICUAW) incidence.
Delirium incidence using the CAM-ICU score.
Duration of mechanical ventilation.
ICU & hospital length of stay |
At ICU discharge(2wks) & at hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
25/03/2026 |
| 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 randomized control trial evaluates the effectiveness of nurse led early mobilization in intensive care unit. Early mobilization means mobilization within 24 to 48 hours of icu admission patients .Primary hypothesis is early mobilization in ICU patients will prevent icu acquired weakness.So patients with eligible criteria will be assigned to intervention group to receive early structured nurse led mobilization within 24 to 48 hours of ICU admission and will be assessed for functional independence measure at hospital discharge and other secondary outcomes like muscle stength,delirium,duration of ICU and hospital length of stay and duration of mechanical ventilation. |