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CTRI Number  CTRI/2026/01/100733 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Integrated Physiotherapy in Improving Muscle Strength and Recovery in Elderly Patients Admitted to Intensive Care Units  
Scientific Title of Study   EFFECT OF INTEGRATED PHYSIOTHERAPY ON INTENSIVE CARE UNIT ACQUIRED WEAKNESS IN CRITICALLY ILL GERIATRIC PATIENTS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepesh Sharma 
Designation  Professor 
Affiliation  Jaipur National University 
Address  Jaipur National University
Department of Physiotherapy Jaipur National University, Near New RTO Office, Jagatpura
Jaipur
RAJASTHAN
302017
India 
Phone  06280838149  
Fax    
Email  drdeepeshsharma@jnujaipur.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Deepesh Sharma 
Designation  Professor 
Affiliation  Jaipur National University 
Address  Jaipur National University
Department of Physiotherapy Jaipur National University, Near New RTO Office, Jagatpura
Jaipur
RAJASTHAN
302017
India 
Phone  06280838149  
Fax    
Email  drdeepeshsharma@jnujaipur.ac.in  
 
Details of Contact Person
Public Query  
Name  Deepesh Sharma 
Designation  Professor 
Affiliation  Jaipur National University 
Address  Jaipur National University
Department of Physiotherapy Jaipur National University, Near New RTO Office, Jagatpura
Jaipur
RAJASTHAN
302017
India 
Phone  06280838149  
Fax    
Email  drdeepeshsharma@jnujaipur.ac.in  
 
Source of Monetary or Material Support  
Jaipur National University, Near New RTO Office, Jagatpura- 302017 
 
Primary Sponsor  
Name  Jaipur national University 
Address  Jaipur National University, Near New RTO Office, Jagatpura- 302017 
Type of Sponsor  Private medical college 
 
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 Deepesh Sharma PT  Jaipur National University Institute of Medical Science and Research Centre  Jaipur National University, Near New RTO Office, Jagatpura-302017
Jaipur
RAJASTHAN 		 06280838149

drdeepeshsharma@jnujaipur.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Internal Ethical Committee of JNUIMSRC  Approved 
Internal Ethical Committee of JNUIMSRC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G737||Myopathy in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General Physiotherapy Intervention   Range of Motion Exercise of all limb for 5- 10 times (Passive- Assisted-Active Twice Daily) + Assisted Bridging- Active Bridging + Assisted Trunk Rotation- Active Trunk Rotation Positioning: Semi-recumbent Position with head of bed elevation 45o (change position within 2 hours to avoid pressure ulcers) In progression supported sitting on the edge of bed for 10-15 minutes. (Closely observe patient’s vital signs (HR, BP, SPO2 and RR) and changes is skin color, respiratory distress sign, Perspiration)  
Intervention  Integrated physiotherapy  In-bed Cycling: will be done. Active Cycling: Patient will be asked to actively cycling for 15 minutes at 3 Modified BORG RPE scale (Intensity). Patient’s Position: Semi-recumbent Position with head of bed elevation 45o TheraBand Exercise: Yellow colored elastic band will be used because it provides light resistance. 10-15 Rep 3 sets Position: Supine & Sitting Lower Limb: Ankle Pump, Clam Shell, Leg Press, Hamstring Curl, Standing Hip Exercise (Forward kick, Backward Kick & Side Kick) Upper Limb: Arm Curl, Arm Raise, Shoulder Blade Squeeze Whole-Body Vibration: Throughout the whole intervention, patients will remain in the supine posture, and any changes in body position will not be permitted in order to prevent any impact on vital signs and hemodynamic parameters. A physiotherapist will warm up patients by passively moving them for six minutes. Following the warm- up, the patient will begin WBV therapy, which entails placing a vibration device beneath their feet and applying resistance to the end of the bed. The patient will have a 20° flexion of the knees and hips. There will be 15-minute WBV sessions. Allow patient to sit out of the bed for few times (HR, RR, SPO2 and BP will be Monitored during each activity)  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ICU stay between 48-72 hours
Hemodynamic stable patients
Intubated & Non-Intubated Patients
S5Q Score=3 
 
ExclusionCriteria 
Details  A pre-existing primary systemic neuromuscular disorder that reduces muscle strength,
such as GBS, ALS or myasthenia gravis
Deformity, paralysis, fracture, or surgery of limbs.
Motor-functioning spinal or intracranial conditions
An intestinal operation within a month.
Patient on renal replacement therapy
Cancer with a very poor prognosis or terminal disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Hand Grip Strength (By JAMAR Hydraulic hand grip dynamometer)
2. Serum Creatinine level  		 At Baseline, At ICU Discharge, At 3 Months Post ICU Discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Serum Calcium Level
Vitamin D level
Blood Glucose Level
Calf Circumference
ICU Mobility Status (BY PERME ICU Mobility Scale)
Adverse Events  		 At Baseline, At ICU Discharge, At 3 Months Post ICU Discharge 
 
Target Sample Size   Total Sample Size="155"
Sample Size from India="155" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   20/01/2026 
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="1"
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 controlled trial aims to evaluate the effect of an integrated physiotherapy protocol on Intensive Care Unit–Acquired Weakness (ICUAW) in critically ill geriatric patients. All eligible participants will be randomly allocated into four groups based on gender and intervention type: Integrated Physiotherapy (male and female) and Routine Physiotherapy (male and female). Baseline demographic and clinical data including age, diagnosis, ventilator mode, hand grip strength,  blood glucose, and calf circumference will be recorded. The integrated physiotherapy program will include in-bed side cycling, TheraBand exercises, whole-body vibration, and breathing exercises, while the control group will receive conventional physiotherapy comprising range of motion, bridging, trunk rotation, and ambulation training. Outcome measures will include hand grip strength, calf circumference, and ICU mobility status assessed at baseline, ICU discharge, and three months post-discharge. The study aims to determine whether integrated physiotherapy accelerates functional recovery and improves muscle strength and other parameters in elderly ICU patients. 
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