| CTRI Number |
CTRI/2024/05/067849 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of inspiratory exercise in type 2 Diabetes Mellitus individuals |
|
Scientific Title of Study
|
Effect of inspiratory muscle training on diaphragmatic emg in individuals with type 2 Diabetes Mellitus:A quasi experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanisha Desai |
| Designation |
PG Student |
| Affiliation |
DR.D Y PATIL COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr. D. Y. Patil College of Physiotherapy,
Cardiorespiratory Sciences Department,
3rd floor Sant Tukaram Nagar,
Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
09923237117 |
| Fax |
|
| Email |
tanishadesaityd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurang Baxi |
| Designation |
Professor |
| Affiliation |
DR.D Y PATIL COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr. D. Y. Patil College of Physiotherapy,
Cardiorespiratory Sciences Department,
3rd floor Sant Tukaram Nagar,
Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9371007824 |
| Fax |
|
| Email |
gaurangbaxi82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurang Baxi |
| Designation |
Professor |
| Affiliation |
DR.D Y PATIL COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr. D. Y. Patil College of Physiotherapy,
Cardiorespiratory Sciences Department,
3rd floor Sant Tukaram Nagar,
Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9371007824 |
| Fax |
|
| Email |
gaurangbaxi82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy,
3rd Floor, Dept. of Cardiopulmonary Physiotherapy,
Sant Tukaram Nagar,
Pimpri Pune 411018.
|
|
|
Primary Sponsor
|
| Name |
Tanisha Desai |
| Address |
Dr. D. Y. Patil College of Physiotherapy,
3rd Floor, Dept. of Cardiopulmonary Physiotherapy,
SAnt Tukaram Nagar,
Pimpri Pune 411018.
|
| 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 Gaurang Baxi |
Dr. D. Y. Patil College of Physiotherapy, Pune |
Dr. D. Y. Patil College of Physiotherapy,
Cardiorespiratory Sciences Department,
3rd floor Sant Tukaram Nagar,
Pimpri, Pune.
Pune
MAHARASHTRA |
9371007824
gaurangbaxi82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Dr.D.Y Patil college of physiotherapy |
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 |
| Intervention |
Inspiratory Muscle Training |
individual seated in upright position,adjusting the resistance level based on individuals capabilities, 6 days a week for 2 weeks once daily for 3 minutes with 1 minute break in between 3 sets .progression based measured based on PImax and PEmax |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
age group from 40-65 years, individuals with confirmed diagnosis of type 2 diabetes mellitus with history of more than 5 years, fasting blood sugar of 99mg/dl or lower is considered non-diabetic, 100mg/dl-125mg/dl is prediabetic and 126mg/dl or higher is considered diabetic. |
|
| ExclusionCriteria |
| Details |
Individuals with thoracic deformities, back pain, acute or chronic respiratory disease, neuromuscular disease, cardiovascular diseases,
individuals who underwent abdominal or chest surgeries less than 3 months back, individuals with a history of copd. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Amplitude of Surface EMG Action Potential
2. Duration of Surface EMG Action Potential |
1. Prior to starting study
2. After 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Maximal inspiratory pressure (PImax)
2. Maximal expiratory pressure (PEmax) |
1. Prior to starting study
2. After 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/06/2024 |
| 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="0"
Months="6"
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
|
The study is a single Arm Quasi experimental study, studying the effect of inspiratory muscle training on diaphragmatic emg in individuals with type 2 diabetes mellitus. The study includes 35 individuals with a history of 5 years or more of type 2 diabetes mellitus. The treatment will be given for two weeks i.e. 6 sessions and pre and post where amplitude and duration of diaphragm with surface emg and maximal inspiratory pressure and maximal expiratory pressure will be measured. |