| 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
|
|
|
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
|
|
|
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. |