| CTRI Number |
CTRI/2024/11/076758 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diaphragm muscle will be released in chronic obstructive pulmonary disease patient where pre and post energy requirement will be recorded
|
|
Scientific Title of Study
|
Effect Of Diaphragmatic Release
Technique On Physiological Cost Index In Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandrika S Satarkar |
| Designation |
Post graduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical sciences, SDM Hospital, OPD No: 13 Manjushree nagar, Sattur, Dharwad, Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
8551981349 |
| Fax |
|
| Email |
satarkarchandrika24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubha Akadas |
| Designation |
Associate Professor, PG Guide |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical sciences, SDM Hospital, OPD No: 13 Manjushree nagar, Sattur, Dharwad, Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9739488007 |
| Fax |
|
| Email |
Shubha.akadas@sdmuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chandrika S Satarkar |
| Designation |
Post graduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical sciences, SDM Hospital, OPD No: 13 Manjushree nagar, Sattur, Dharwad, Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
8551981349 |
| Fax |
|
| Email |
satarkarchandrika24@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF
SDM college of Medical Sciences SDM Hospital OPD no 13 Cardiorespiratory department Sattur Dhawad Karnataka India 580009 |
|
|
Primary Sponsor
|
| Name |
Chandrika S Satarkar |
| Address |
SDM College of Medical sciences, SDM Hospital, OPD No: 13 Manjushree nagar, Sattur, Dharwad, Karnataka |
| 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 |
| Chandrika S Satarkar |
SDM Hospital |
OPD No: 13 Cardiorespiratory department Manjushree nagar, Sattur, Dharwad, Karnataka
Dharwad
KARNATAKA |
8551981349
satarkarchandrika24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- SDM College of Medical Sciences & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diaphragmatic Release Technique |
The therapist applies pressure on the bottom of the
costal cartilage spanning the seventh to tenth ribs
using the pisiform, hypothenar area, and the final three fingers. In tandem with the participants elevation
movement of the ribcage, the therapist softly pulls in a
cephalad direction during the inspiration. The therapist
extends contact in the direction of the inner costal
margin during the breath. With each following breath,
the therapist works to establish a smoother and deeper touch. Two sets of ten deep breaths will be used for the technique, with a one-minute break in between for 3 to 4 minutes duration twice a day for 3 to 4 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individual diagnosed with Chronic Obstructive
Pulmonary Disease by physician/pulmonologist.
Hemodynamically stable Chronic Obstructive
Pulmonary Disease patients.
Individuals who are not dependent on oxygen.
Both genders will be included.
Patient of age group between 40 to 65 years.
smokers and non-smokers
Individuals with stable comorbidities like
Hypertension, Diabetes mellitus, chronic kidney
disease with precaution and on medication.
Individuals who are willing to participate in the
study.
Individuals who can communicate |
|
| ExclusionCriteria |
| Details |
Individuals with recent thoracic/abdominal
surgeries.
Individual having rib fracture, recent thoracic
surgeries.
Individuals with existing neurological
conditions.
Uncooperative/unwilling individuals.
Individuals with locomotive disorders
Individuals with musculoskeletal condition.
Termination for 6minute walk
test.(Palpitation, Giddiness, Unstable vitals) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the effect of diaphragm release on
physiological cost index in individuals with Chronic
Obstructive Pulmonary Disease |
To find out the effect of diaphragm release on
physiological cost index in individuals with Chronic
Obstructive Pulmonary Disease will be assessed at baseline and after 4 days immediate after intervention for perceived rate of exertion |
|
|
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)
|
25/11/2024 |
| 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
|
Patient of age group between 40 to 65 years diagnosed of COPD by a pulmonologist or a registered medical practitioner will be selected. Participants who give the written consent will be screened for the inclusion and exclusion criteria. Every subject’s demographic information will be recorded .A Six minute walk test will be carried out pre- intervention. The test’s objective is to have the subjects walk as far as possible for six minutes. At this point, measurements of baseline parameters like heart rate and oxygen saturation are made before and after test. The distance walked is measured and recorded.16 After six minute walk test, the rate of perceived  exertion is measured using modified borg scale. Patients will be advised to point to the number on the Borg scale that most accurately represented how hard they were breathing at that specific moment in order to measure their effort. The diaphragmatic release technique will be performed according to the protocol described by Rocha et al. While the patient is in a supine position, the therapist applies pressure on the bottom of the costal cartilage spanning the seventh to tenth ribs using the pisiform, hypothenar area, and the final three fingers. In tandem with the participant’s elevation movement of the ribcage, the therapist softly pulls in a cephalad direction during the inspiration. The therapist extends contact in the direction of the inner costal margin during the breath. With each following breath, the therapist works to establish a smoother and deeper touch. Two sets of ten deep breaths will be used for the technique, with a one-minute break in between. Diaphragm release technique will be performed twice a day for 3 to 4 days.10 After which six minute walk test and modified Borg scale will be assessed again to see the effect of diaphragm release technique on PCI. Both pre and post values will be compared to each other in terms of the outcome measures mentioned above. Conventional physiotherapy like breathing exercises, airway clearance technique, postural drainage will be given to all the patients according to their requirements/condition along with Diaphragmatic release technique . |