| CTRI Number |
CTRI/2025/02/079889 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to Assess Effectiveness of Sitting Breathing Exercise on Bio-physiological Parameters among patients with Type 2 Diabetes Mellitus in selected tertiary care hospital at Mangaluru. |
|
Scientific Title of Study
|
Effectiveness of Sitting Breathing Exercise on Bio-physiological Parameters among patients with Type 2 Diabetes Mellitus in selected tertiary care hospital at Mangalore. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHAMMED SAHAD |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Yenepoya (Deemed to be University) |
| Address |
Department of Medical Surgical Nursing,
Yenepoya Nursing College
Naringana, Deralakatte,
Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8593018768 |
| Fax |
|
| Email |
mohammedsahadpv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GIREESH GR |
| Designation |
ASSOCIATE PROFESSOR & HOD |
| Affiliation |
Yenepoya (Deemed to be University) |
| Address |
Associate Professor & HOD
Department of Medical Surgical Nursing
Yenepoya Nursing College
Naringana, Deralakatte,
Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916284717 |
| Fax |
|
| Email |
gireeshsachin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHAMMED SAHAD |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Yenepoya (Deemed to be University) |
| Address |
Department of Medical Surgical Nursing
Yenepoya Nursing College
Naringana, Deralakatte,
Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8593018768 |
| Fax |
|
| Email |
mohammedsahadpv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital Mangaluru
Deralakatte, Mangalore, Karnataka, India. PIN: 575018 |
|
|
Primary Sponsor
|
| Name |
MOHAMMED SAHAD |
| Address |
YENEPOYA NURSING COLLEGE
NARINGANA, DERALAKATTE
MANGALURU, KARNATAKA, INDIA. PIN:575018 |
| 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 |
| Dr Habib Rahaman A A |
YENEPOYA MEDICAL COLLEGE HOSPITAL |
Medicine wards, 2nd floor, DERALAKATTE
MANGALURU
PIN 575018
Dakshina Kannada
KARNATAKA |
0824 2206000
reachus@yenepoya.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| YENEPOYA ETHICS COMMITTEE 2 |
Approved |
| YENEPOYA ETHICS COMMITTEE 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal regular treatment(Insulin therapy, drug therapy and Combined therapy) |
Normal regular treatment followed in Hospital for Type 2 Diabetes Mellitus Patients(Insulin therapy, drug therapy and Combined therapy).Dosage of the drug is not applicable. |
| Intervention |
SITTING BREATHING EXERCISE |
Sitting breathing exercise is performed as the following:
a. The patient takes slow deep breathing (inhalation) while in a sitting position.
b. At the same time the patient count on his fingers 1,2,3,4 and 5 then slow inspiration then hold the breath for moment while counting 1, 2, and 3 on fingers of his/her hand after that a slow long exhale while counting 1, 2, 3, 4 and 5 on fingers of his/her hand until the end of the respiratory cycle. This exercise will be carried out for 5-10 minutes about 2 times a day.
4. Post tests will be conducted on 3rd ,5th and 7th day in order to find out the changes in both the groups. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
Type 2 diabetes mellitus patients admitted in hospital
• Aged 20- 60 years.
• Ability to comprehend and follow study instructions.
• Ability to sit comfortably for a specified duration.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Description of demographic characteristics of patients with Type 2 Diabetes Mellitus.
2. Pretest scores of biophysiological parameters between the study groups.
3. Effectiveness of sitting breathing exercise on bio-physiological parameters among patients with type 2 diabetes mellitus.
4. Association of pretest scores of biophysiological parameters with the selected socio-demographic variables.
|
pretest will be conducted on day 1 followed by post tests 1,2 and 3 respectively on day 3,5 and 7. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| various studies shown that there is significant reduction blood glucose level, blood pressure. |
pretest will be conducted on day 1 followed by post tests 1,2 and 3 respectively on day 3,5 and 7. |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
14/02/2025 |
| 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="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Proposal will be sent to the Scientific Review Board for approval.
Formal permission will be obtained from the Ethical Committee of Yenepoya
(Deemed to be University), Mangalore. Permission will be taken from Medical Superintendent of Yenepoya
Medical college Hospital, Mangalore. After obtaining the informed consent the experimental group receives
sitting breathing exercise whereas the controlled group receives the normal
routine treatments.
Sitting breathing exercise is performed as the following:
a. The patient takes slow deep breathing (inhalation) while in a sitting
position.
b. At the same time the patient count on his fingers 1,2,3,4 and 5 then
slow inspiration then hold the breath for moment while counting 1, 2, and 3 on
fingers of his/her hand after that a slow long exhale while counting 1, 2, 3, 4
and 5 on fingers of his/her hand until the end of the respiratory cycle. This
exercise will be carried out for 5-10 minutes about 2 times a day. Post tests
will be conducted on 3rd ,5th and 7th day in order to find out the
changes in both the groups. |