| CTRI Number |
CTRI/2025/07/090949 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Helping people with severe lung illness (ARDS) recover: Comparing early movement and bedside cycling on activity, health, and hospital stay. |
|
Scientific Title of Study
|
Impact of early mobilization in comparison with cycle ergometer on physical activity, physiological parameters and length of hospital stay in individuals with acute respiratory distress syndrome. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakshita Ramesh Pandari |
| Designation |
Post graduate student |
| Affiliation |
SDM College of physiotherapy |
| Address |
OPD no 13, Department of
Cardio-respiratory disorders, SDM College Of Physiotherapy,
Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
Dharwad
OPD no 13, Department of Cardio-respiratory disorders, SDM
College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad,
Karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7676677454 |
| Fax |
|
| Email |
rakshita.rp127@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakshita Ramesh Pandari |
| Designation |
Post graduate student |
| Affiliation |
SDM College of physiotherapy |
| Address |
OPD no 13, Department of
Cardio-respiratory disorders, SDM College Of Physiotherapy,
Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
Dharwad
OPD no 13, Department of Cardio-respiratory disorders, SDM
College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad,
Karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7676677454 |
| Fax |
|
| Email |
rakshita.rp127@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta Appannavar |
| Designation |
Associate professor and PG guide |
| Affiliation |
SDM College of physiotherapy |
| Address |
OPD no 13, Department of Cardio-respiratory disorders, SDM
College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad,
Karnataka 580009
OPD no 13, Department of Cardio-respiratory disorders, SDM
College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad,
Karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9591753487 |
| Fax |
|
| Email |
sangeeta.appannavar@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| OPD no. 13, SDM College Of Physiotherapy Manjushree Nagar, Sattur, Dharwad-580009, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Rakshita Ramesh Pandari |
| Address |
SDM College Of Physiotherapy SDM College Of Medical Sciences
And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Rakshita Ramesh Pandari |
Shri Dharmasthala Manjunatheshwara hospital |
Cardiorespiratory
Department OPD no 13
Manjushree Nagar
Sattur Dharwad
Karnataka
Dharwad-580009
KARNATAKA
Dharwad
KARNATAKA |
7676677454
rakshita.rp127@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM College Of Medical Sciences And Hospital |
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 |
Early mobilization |
Total duration-15to20mins.1.Active ROM.2.Passive ROM.3.Low intensity theraband exercises.4.Bed mobility training.5.Transfer from supine to sitting.6.Spot marching .7.Ambulation around the bed and in the ICU.8.Incentive spirometer.9.Airway clearance techniques. |
| Intervention |
Early mobilization with cycle ergometer |
Duration-15to20mins.1.Active ROM. 2.Passive ROM.3.Low intensity theraband exercises.4.Bed mobility training.5.Supine to sit transfer.6.Spot marching.7.Ambulation around the bed and in the ICU.8.Cycle ergometer (5-10mins).9.Incentive spirometer
10.Airway clearance techniques. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals diagnosed with acute respiratory distress syndrome (ARDS)2.Individuals admitted in the Intensive care unit and hospital.3. Individuals with or without mechanical ventilator.4.All genders.5.Individuals of age group between 20 to 60 years.6.Individuals who are willing to participate in the study.7.Individuals with post-covid status.8.Individuals who are on NIV trial. |
|
| ExclusionCriteria |
| Details |
1.Individual having acute respiratory distress syndrome caused by non-
pulmonary etiological factors.2.Individuals pre diagnosed with co-morbidities like cardiac, renal etc.3.Individuals with traumatic injury to
thoracic cage.4.Significant dose of vasopressors for hemodynamic stability.5.Mechanically ventilated with FiO2 greater than 0.8 or positive end expiratory pressure greater than 12, or acutely worsening respiratory failure.6.Individuals with Neuromuscular paralytics.7.Unstable spine or extremity fractures. 8.Grave prognosis,transitioning to comfort care.9.Open abdomen, at risk for dehiscence.10.Active bleeding process. 11.Bed rest order.12.Individuals on psychiatric medications over a period of time.13.Individuals who are uncooperative/irritable.14.Functional status score in intensive care unit (FSS-ICU) mobility score is 0.15. Glasscow coma scale less than 8. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
FSS-ICU, ABG analysis, ICU mobility scale and physiological
parameters |
1st day, every 7th day and on the day of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/09/2025 |
| 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="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 study explores the recovery process in Acute respiratory distress syndrome patients by examining how quickly the individuals regain independence in daily activities. It also assesses the benefits of combining cycle ergometer therapy with early mobilization in improving physiological functions, reducing hospital stay and enhancing overall physical activity levels |