FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067350 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparison of Hand on therapy and Diaphragmatic Manipulation on Diaphragmatic Movement, Chest Expansion and Exercise Capacity in patients diagnosed with COPD- 4 week follow up study 
Scientific Title of Study   Comparison of Manual therapy and Diaphragmatic Maneuver on Diaphragmatic Excursion, Thoracic Mobility and Exercise Capacity in patients with COPD: A Randomized Clinical 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 Shraddha R Boratwar 
Designation  Postgraduate student 
Affiliation  MGM Institute of Physiotherapy  
Address  Department of Cardiovascular and respiratory Physiotherapy, OPD-4, MGM Institute of Physiotherapy.

Aurangabad
MAHARASHTRA
431003
India 
Phone  7887696107  
Fax    
Email  shraddhaboratwarpg@mgmiop.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Dobhal 
Designation  Associate Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Cardiovascular and respiratory Physiotherapy, OPD-4, MGM Institute of Physiotherapy.

Aurangabad
MAHARASHTRA
431003
India 
Phone  9923401079  
Fax    
Email  santoshdobhal@mgmiop.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Shraddha R Boratwar 
Designation  Postgraduate student 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Cardiovascular and respiratory Physiotherapy, OPD-4, MGM Institute of Physiotherapy.

Aurangabad
MAHARASHTRA
431003
India 
Phone  7887696107  
Fax    
Email  shraddhaboratwarpg@mgmiop.edu.in  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy Aurangabad MAHARASHTRA 431003 India 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy 
Address  N6-Cidco,Aurangabad MAHARASHTRA 431003 India 
Type of Sponsor  Research institution and hospital 
 
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 Shraddha R Boratwar  MGM Medical College and Hospital  Department of Pulmonary Medicine, MGM Medical college and Hospital, N-6 Cidco Aurangabad MAHARASHTRA
Aurangabad
MAHARASHTRA 		 07887696107

shraddhaboratwarpg@mgmiop.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Institue of Physiotherapy Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diaphragmatic Maneuver plus conventional therapy   Diaphragmatic maneuver techniques along with conventional therapy will be given to the mild to moderate COPD patients three times a week for 4 weeks 
Intervention  Manual therapy plus conventional therapy  Manual therapy along with conventional therapy will be given to the mild to moderate COPD patients three times a week for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Inpatients or outpatients diagnosed with stable COPD and exhibiting peripheral oxygen saturation is greater than 92% during calm breathing.
2.Patients with mild or moderate COPD according to the GOLD criteria.
3.Patient not involved in previous rehabilitation program at least 4 months prior to study.
4.Age 18-75 years
5.Both Male and Female 
 
ExclusionCriteria 
Details  1.Patients with acute exacerbation of COPD in past month.
2.Patients with unstable hemodynamic parameters arterial pressure less than 100mmHg systolic and less than 60mmHg for diastolic and mean arterial
pressure less than 80mmHg.
3.Patients who have undergone recent cardiothoracic or abdominal surgery.
4.Patients who have a recent history of chest wall or abdominal trauma and substantial chest wall deformity.
5.History of psychiatric illness or difficulty in comprehending commands and following instructions.
6.Cardiovascular problems
7.Musculoskeletal disorders
8.Acute rib fractures
9.Severe osteoporosis 
 
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 
Diaphragmatic Excursion  7 mins 
 
Secondary Outcome  
Outcome  TimePoints 
1.Chest Expansion
2.6 minute walk test 		 15 mins 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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 2 
Date of First Enrollment (India)   25/05/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shraddhaboratwarpg@mgmiop.edu.in].

  6. For how long will this data be available start date provided 30-06-2025 and end date provided 31-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Patients diagnosed with COPD (mild to moderate) age groups between 18 to 75 years old will be taken.
The participants that meet the inclusion criteria will be chosen for the study. Written and oral consent from the participants will be obtained, and all procedures will be explained. Demographic data and assessment data will be taken. Baseline data, which includes diaphragmatic excursion, chest expansion, and the 6-minute walk distance of all the participants, will be taken. Patients are randomly allocated into groups (Group A & Group B). Both groups receive the intervention. Group A will given manual therapy along with conventional exercises, and Group B will given diaphragmatic maneuver technique along with conventional exercises. In manual therapy, muscle energy techniques will be applied to the thoracic cage, with three techniques for the lower thorax and two for the upper thorax, while in the diaphragmatic maneuver technique, two techniques will involve the manual diaphragmatic release technique and the diaphragmatic stretch technique. In conventional exercises, patients will perform diaphragmatic breathing combined with pursed lip breathing, and breathing exercises with upper limb movement. The session will be provided for around 30 to 40 minutes three times a week for 4 weeks. If the patient feels any type of discomfort, treatment should be stopped. After the intervention period, all the outcomes will be checked to assess the progression of all the parameters. A statistical analysis of the collected data will be conducted. A conclusion will be established based on the results of the study.
 
Close