CTRI

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CTRI Number

CTRI/2025/02/080089 [Registered on: 07/02/2025] Trial Registered Prospectively

Last Modified On:

03/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)
Other (Specify) [ROM]

Study Design

Other

Public Title of Study

Early Mobilization on Intensive Care Unit Acquired Weakness and Functional Independence

Scientific Title of Study

A study to assess the effectiveness of early mobilization on Intensive care unit acquired weakness and functional independence among patients admitted at tertiary care center

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	David M
Designation	Student
Affiliation	Sri Ramachandra Institute of Higher Education and Research (DU)
Address	Hall 11 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai 600116 Chennai TAMIL NADU 600116 India
Phone	9566479757
Fax
Email	N1623006@sriher.edu.in

Details of Contact Person
Scientific Query

Name	David M
Designation	Student
Affiliation	Sri Ramachandra Institute of Higher Education and Research (DU)
Address	Hall 11 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai 600116 Chennai TAMIL NADU 600116 India
Phone	9566479757
Fax
Email	N1623006@sriher.edu.in

Details of Contact Person
Public Query

Name	Maria Mazarrello A
Designation	Lecturer
Affiliation	Sri Ramachandra Institute of Higher Education and Research (DU)
Address	Faculty Room 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai 600116 Chennai TAMIL NADU 600116 India
Phone	9840186262
Fax
Email	mariamazarrello@sriramachandra.edu.in

Source of Monetary or Material Support

Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai Tamil Nadu India 600116

Primary Sponsor

Name	Sri Ramachandra Institute of Higher Education and Research DU
Address	Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai Tamil Nadu India 600116
Type of Sponsor	Research institution and hospital

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 Vel Murugan	Sri Ramachandra Medical Center	Department of Critical Care Medicine 4th Floor C4 Room No-3 Chennai TAMIL NADU	9968859560 drvelsri86@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sri Ramachandra Institute of Higher Education and Research (DU)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M629\|\|Disorder of muscle, unspecified, (2) ICD-10 Condition: M625\|\|Muscle wasting and atrophy, not elsewhere classified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Range of motion and bed mobility activity	The Range of motion (ROM) will be given by the investigator in one to one session for the patient with 10 minutes duration for 2 sessions everyday for 3 days along with the routine care. Range of motion Shoulder – adduction, abduction, internal rotation and external rotation Elbow –flexion, extension Wrist- extension, flexion, radial and ulnar deviation, internal rotation Hip – abduction, adduction, flexion, extension knee- flexion, extension Ankle - inversion, eversion Foot – dorsiflexion, plantarflexion Bed mobility movement- Rolling, turning, lying to sitting in bed, bridging Duration of intervention 10 minutes.the total duration intervention is 60 minutes
Comparator Agent	Routine Care	The control group will not receive Range of Motion and Bed Mobility Activity intervention They will receive only routine care

Inclusion Criteria

Age From	20.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Age greater than 20 years Both Male and Female Conscious Patients Non Ventilated Patients

ExclusionCriteria

Details

Not willing to participate in this study
Pregnancy
Any Deformities
Fracture or Surgery
Intracranial or Spinal condition affecting motor Function
Spinal Cord Injury
Neuromuscular Disease
Delirium

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Incidence and severity of ICU-acquired weakness (ICU-AW) can be measured using standardized tools like the Medical Research Council (MRC) sum score, where a score of less than 48 indicates ICU-AW. Assessments can be performed at ICU Admission or at specific time points during the ICU stay.	Pre-test- After 24 hours of ICU Admissions Post-test I After 48 hours of ICU Admission Post-test II After 72 hours of ICU Admission

Secondary Outcome

Outcome	TimePoints
Functional Independence is Measured using scales like Katz Index of Independence in Activities of Daily Living at ICU Admission or specific time points during the ICU stay.	Pre-test- After 24 hours of ICU Admission Post-test I After 48 hours of ICU Admission Post-test II After 72 hours of ICU Admission

Target Sample Size

Total Sample Size="160"
Sample Size from India="160"
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)

20/02/2025

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="0"
Months="3"
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

Purpose:

The study aims to evaluate the effectiveness of early mobilization in reducing the incidence and severity of ICU-acquired weakness (ICU-AW) and improving functional independence among critically ill patients. The goal is to determine whether early physical activity interventions can lead to better muscle strength, functional outcomes, and faster recovery.

Methods:

Study Design: Randomized controlled trial using block randomization to ensure balanced allocation of participants into intervention and control groups.

Participants: Critically ill patients admitted to tertiary care centers who meet inclusion criteria for early mobilization.

Intervention Group: Received early mobilization protocols, including passive and active exercises, sitting, standing, and ambulation as tolerated.

Control Group: Received standard ICU care without structured early mobilization.

Results:

Early mobilization significantly reduced the incidence of ICU-AW, with higher MRC scores observed in the intervention group compared to controls. Patients in the intervention group also demonstrated greater functional independence, as indicated by higher Katz ADL scores at discharge. Additionally, there were trends toward shorter ICU stays and reduced duration of mechanical ventilation in the intervention group. No significant adverse events related to mobilization were reported.