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CTRI Number  CTRI/2026/03/105982 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Graded Early Mobilization on Non-Invasive vs Invasive Mechanical Ventilation in COPD Patients with Acute Respiratory Failure 
Scientific Title of Study   Evaluation of Comparative Efficacy of Graded Early Mobilization with Conventional Physiotherapy on Non-Invasive vs Invasive Mechanical Ventilation in COPD Patients with Acute Respiratory Failure: 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  Dr Arijit Kumar Das 
Designation  PhD Scholar  
Affiliation  Ravi Nair Physiotherapy College, Wardha 
Address  Department of Cardiovascular & Respiratory Physiotherapy, Ravi Nair Physiotherapy College, DMIMS, Wardha.
Department of Cardiovascular & Respiratory Physiotherapy, Ravi Nair Physiotherapy College, DMIMS, Wardha.
Wardha
MAHARASHTRA
442007
India 
Phone  9545174855  
Fax    
Email  arijitdasphysio@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Irshad Qureshi  
Designation  Principal 
Affiliation  Ravi Nair Physiotherapy College, Wardha 
Address  Department of Cardiovascular & Respiratory Physiotherapy, Ravi Nair Physiotherapy College, DMIMS, Sawangi, Wardha
Department of Cardiovascular & Respiratory Physiotherapy, Ravi Nair Physiotherapy College, DMIMS, Sawangi, Wardha
Wardha
MAHARASHTRA
442007
India 
Phone  9406010010  
Fax    
Email  irshad.qureshi@dmiher.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijit D Diwate 
Designation  HOD & Professor 
Affiliation  Dr. Vithalrao Vikhe Patil Foundations, College of Physiotherapy, Ahmednagar 
Address  Dept. Cardiovascular & Respiratory Physiotherapy, Dr. Vithalrao Vikhe Patil Foundations, College of Physiotherapy
Department of Cardiovascular & Respiratory Physiotherapy, Dr. Vithalrao Vikhe Patil Foundations, College of Physiotherapy
Ahmadnagar
MAHARASHTRA
414111
India 
Phone  8554990222  
Fax    
Email  abhijitdiwate@gmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy College, DMIMS, Sawangi (M) Wardha, Maharashtra, India- 442007 
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College, Wardha 
Address  Ravi Nair Physiotherapy College, DMIMS, Sawangi (M) Wardha, Maharashtra, India- 442007 
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 Mohd Irshad Qureshi   Acharya Vinoba Bhave Rural Hospital, Wardha  Respiratory- ICU, Department of Chest Medicine, Acharya Vinoba Bhave Rural Hospital, DMIHER, Sawangi (M)
Wardha
MAHARASHTRA 
9406010010

irshadphysio@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH, INSTITUTIONAL ETHICS COMMITTEE, SAWANGI, WARDHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J80||Acute respiratory distress syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Graded Early Mobilization with Conventional Physiotherapy on Invasive Mechanically Ventilation  Total Duration for each patient 5 days. Total duration of the study 1 year. For Invasive ventilated patients - Early and progressive mobility protocol along with Standard Physiotherapy. Standard physiotherapy will be given twice a day and early mobilization will be given once a day total for 5 days 
Intervention  Graded Early Mobilization with Conventional Physiotherapy on Non- Invasive Mechanically Ventilation  Total Duration for each patient is 5 days. Total duration of study 1 years For Non-invasive Ventilated patients - Early and progressive mobility protocol along with Standard Physiotherapy. Standard physiotherapy will be given twice a day and early mobilization will be given once a day total for 5 days 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subject will be included only when diagnosed with COPD with Acute Respiratory Failure by the Intensivist or Respiratory Medicine Specialist, by the criteria of partial pressure of arterial oxygen (PaO2) less than 60 mmHg from ABG analysis report or a pulse oximetry reading (SpO2) less than 90%. (Naughton, 2020)
2. Subject will be included when admitted to the ICU and will be on non-invasive or invasive mechanical ventilation within 24 hours with standard PEEP of 5 ± 2 cm H2O. with CPAP mode. (Grieco, 2021)
3. Independent in functional activities before admission to the hospital.
 
 
ExclusionCriteria 
Details  1. Subject will be excluded if not diagnosed with COPD with ARF.
2. Subject will be excluded if they have a history of undergoing any surgery, like thoracic, cardiac, abdominal, or fractures.
3. Subject will be excluded if they have any condition that restricts mobility.
4. Subject will be excluded if they have ulcers or open wounds.
5. Subject will be excluded if they have been medically diagnosed with Cancer or metastasis or history of Chemotherapy or radiotherapy within the previous 6 months.
6. Subject will be excluded if they have already been medically diagnosed with neurological deficits or neuromuscular disease
7. Subject will be excluded if they have invasive femoral arterial lines or are on immunosuppression therapy.

 
 
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 
PaO2 - ABG Investigation  Base Line & on the 5th day 
 
Secondary Outcome  
Outcome  TimePoints 
SpO2 – Pulse Oximeter  Base Line & on the 5th day  
Fatigue - Fatigue Assessment Scale (FAS)  Base Line & on the 5th day 
Perme Intensive Care Unit Mobility Score  Base Line & on the 5th day 
Respiratory Distress Observation Scale (RDOS)  Base Line & on the 5th day 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   10/04/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The aim of the study is to assess the effect of Graded Early Mobilization with Conventional Physiotherapy on Non-Invasive Mechanically Ventilation and compare the effect with Mechanically Ventilation in COPD Patients with Acute Respiratory Failure on oxygenation, Fatigue, and ICU mobility.

Patient will be already diagnosed with COPD with Acute Respiratory Failure medically at the Tertiary care hospital by Arterial Blood Gas (ABG) by the clinician and referred for Physiotherapy. Then, the patient who is willing to participate in the study will be screened for inclusion and exclusion criteria. The patient’s family member will be provided with an adequate explanation of the proposed benefits, hazards, procedures, and treatment protocol included in the study in the language they understand best, and signed informed consent (Informed Assent) will be obtained in their native tongue. The participants were randomized (allocated) into two groups (group A and group B) using a computer-generated randomization list.

Group A – (Experimental Group) –    Graded Early Mobilization with Conventional Physiotherapy on  Non-Invasive Mechanical Ventilation

Group – B (Control Group) –             Graded Early Mobilization with Conventional Physiotherapy on Invasive Mechanical Ventilation

To assess the safety of the treatment session, all patients will be instructed to report any difficulty or problem before, during, or after it. Every intervention will be carried out under observation and control. Both the groups will be given the treatment. All the safety and aseptic measures will be followed during the treatment. Taking into consideration the critically ill patients assistance will be taken to monitor the vitals (ICU nurses). Using a pulse oximeter, the patients’ vital signs (heart rates, saturation) were continuously tracked. If the saturation will drop by more than 90%, the intervention will be stopped. Each patient will received individual care from a physiotherapist during the intervention. Patient will be observed for all the lines attached, any leakage from the source, temperature raise or any discomfort sign. Treatment will be given for 5 days two times a day, The medications and history of last feed was taken into consideration and all medical intervention will be continue as per instruction of doctor. Pre intervention and after 5 days post treatment will be documented. A statistical test will be performed after data collection.

Group A Intervention for the experimental group: - Graded Early Mobilization with Conventional Physiotherapy on Non- Invasive Mechanically Ventilation.

In this group all Non- Invasive mechanically Ventilated Patient will get Graded physiotherapy Protocol with Standard Physiotherapy.

Standard Physiotherapy: Received conventional chest physiotherapy treatment that included Percussion, Vibration, ACBT, Passive ROM Movements for bilateral upper and Lower limb, Bilateral tendo-Achillis stretch 2 times in a day.

Graded Early Mobilization - Early and progressive mobility protocol along with Standard Physiotherapy they will receive active mobilization exercises that focused on all the joints including upper back, shoulder, trunk. The patients will ask to perform daily life activities like shifting the bottle from right to left. Picking up an object by bending down, pulling a string as well as pushing an object for resistance to the muscles, the progression will be making patient sit with back straight without support, once that will achieve, patient will be progressed to edge of bed sitting according to patients’ tolerance level. The intervention protocol and its progression will be according to the ten strategies to optimize early mobilization as published protocol in 2020 by Aishwarya Gatty, with some modifications made according to the outcomes expected.  Scoring will be done immediately post-mobilization sessions. Mobilization session on a particular day will be stopped if patients met any criteria for discontinuation. Safety criteria, red flags and termination criteria will be followed.  As standard physiotherapy will be given two times a day and early mobilization will be given one time in a day total for 5 days.

Group B Intervention for the control group: - Graded Early Mobilization with Conventional Physiotherapy on Invasive Mechanically Ventilation. In this group all Invasive mechanically Ventilated Patient will get Graded physiotherapy Protocol with Standard Physiotherapy.  In this control group will receive same treatment as experimental group receive but patients will be Invasively Mechanically Ventilated. 

 
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