| CTRI Number |
CTRI/2024/04/065110 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can AirOFit PRO Device Help COPD Patients? |
|
Scientific Title of Study
|
Effect of AirOFit PRO Device on Maximal Expiratory Pressure, Pulmonary Functions, Functional Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease Patients: 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 |
Pooja Ramesh Tiwari |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Cardiovacular and Respiratory Physiotherapy, Ravi Nair Physiotherapy College, DMIHER (DU), Sawangi (Meghe) Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7387840680 |
| Fax |
|
| Email |
poojartiwari06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu Vardhan |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Cardiovascular and Physiotherapy, Ravi Nair Physiotherapy College, DMIHER (DU), Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnudiwakarpt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu Vardhan |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, Ravi Nair Physiotherapy College, DMIHER (DU), Sawangi (Meghe) Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnudiwakarpt@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ravi Nair College of Physiotherapy, Acharaya Vinobha Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research [Deemed To Be University], Sawangi Meghe Wardha, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College Wardha |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research [Deemed To Be University] Sawangi, Wardha. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pooja Ramesh Tiwari |
Acharya Vinobha Bhave Rural Hospital from In and Out Respiratory Medicine Ward. |
Department of Cardiovascular and Respiratory Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research [Deemed To Be University] Sawangi, Wardha.
Wardha
MAHARASHTRA |
7387840680
poojartiwari06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Of Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AirOFit PRO device along with convetional chest physiotherapy |
By AirOFit Pro Device participant will performe six easy trials 3 times inspiratory and 3 times expiratory as a warm-up and familiarity with the procedure. After 10 minutes, six maximum trials will be made 3 times inspiratory and 3 times expiratory with 45 seconds rest between efforts, and the largest one will be recorded as the best trial along with conventional chest physiotherapy in this Pursed lip breathing Diaphragmatic breathing,
Upper & lower limb mobility exercises, Upper limb strengthening exercises,
Bed side sitting, Thoracic expansion,Incentive spirometry, ACBT for active patients with secretion, Early ambulation.
The duration of this intervetion will 45 minutes for 2 weeks.
|
| Comparator Agent |
Convectional chest physiotherapy |
Pursed lip breathing, Diaphragmatic breathing,
Upper and lower limb mobility, exercises Upper limb, strengthening exercises,
Bed side sitting,
Thoracic expansion,
Incentive spirometry, and
ACBT for active patients with secretion
Early ambulation
The Duration of this intervention will be of 20 minutes for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients clinically diagnosed with chronic obstructive pulmonary disease.
Patients of Grade I & II of chronic obstructive pulmonary disease.
Age group 40 to 70 years.
Both male and female.
Patient with ability to understand and follow instructions
|
|
| ExclusionCriteria |
| Details |
Patients of Grade III & IV of chronic obstructive pulmonary disease.
Uncooperative patients
Patients with other Cardiovascular, Respiratory, and neurological diseases
Patients with any type of infectious pulmonary disease.
The Patients with grade 4 and grade 5 breathlessness.
Patients with restrictive lung disease.
Chest Trauma, Thoracic vertebral fracture, and Rib fracture
|
|
|
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 |
MicroRPM (respiratory pressure meter)
6 MWD (minute walk distance)
Pulmonary Function Test
|
MicroRPM (respiratory pressure meter)
6 MWD (minute walk distance)
Pulmonary Function Test
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CAT score (COPD Assessment test) |
Baseline and after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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 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
|
To find the effect of AirOFit PRO device on maximal
expiratory pressure, pulmonary functions, functional capacity, and quality of
life in COPD patients. |