| CTRI Number |
CTRI/2024/08/072318 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative study |
| Study Design |
Other |
|
Public Title of Study
|
Challenges and Helpful Factors for Exercise in Young People with Adult-Onset Diabetes |
|
Scientific Title of Study
|
Barriers and facilitators to physical activity participation in maturity onset diabetes of young |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sabha anjum B Peerjade |
| Designation |
Postgraduate student |
| Affiliation |
Sdm college of physiotherapy sattur dharwad |
| Address |
OPD number 13 Community Physiotherapy Department SDM College
of Medical sciences and Hospital Manjushree nagar Sattur Dharwad
karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7795677567 |
| Fax |
|
| Email |
sabhaanjum453@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sabha anjum B Peerjade |
| Designation |
Postgraduate student |
| Affiliation |
Sdm college of physiotherapy sattur dharwad |
| Address |
OPD number 13 Community Physiotherapy Department SDM College
of Medical sciences and Hospital Manjushree nagar Sattur Dharwad
karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7795677567 |
| Fax |
|
| Email |
sabhaanjum453@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHWETA BHATBOLAN |
| Designation |
ASSOCIATE PROFESSOR AND PG GUIDE |
| Affiliation |
Sdm college of physiotherapy sattur dharwad |
| Address |
OPD number 13 Community Physiotherapy Department SDM College of Medical sciences and Hospital Manjushree nagar Sattur Dharwad karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9916067268 |
| Fax |
|
| Email |
shweta.bhatbolan@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Sdm college of medical sciences and hospital manjushree nagar sattur dharwad 580009 |
|
|
Primary Sponsor
|
| Name |
Sabhaanjum B Peerjade |
| Address |
OPD number 13 Community Physiotherapy Department SDM College
of Medical sciences and Hospital Manjushree nagar Sattur Dharwad
karnataka 580009
Dharwad
KARNATAKA
580009 |
| 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 |
| SABHAANJUM B PEERJADE |
SDM Hospital Dharwad |
OPD number 13
Community
Physiotherapy SDM College of
medical sciences and hospital
Manjushree Nagar
Sattur Dharwad
Dharwad
KARNATAKA
Dharwad
KARNATAKA |
7795677567
sabhaanjum453@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SDM College of Medical Sciences and Hospita |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E13||Other specified diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals between 18 to 45 years of age
2. Individuals diagnosed with MODY by the
certified medical practitioner and willing to
participate in the study.
3. Either of the gende |
|
| ExclusionCriteria |
| Details |
1. Recent injuries which hinder them from
activity participation.
2. Any diagnostic psychological conditions
which hampers from activity participation.
3. Persons who cannot understand the
language. (i.e., English, Kannada, Hindi).
4. Individuals diagnosed with type 1 diabetes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The purpose of this study is to examine the
perceived barriers and facilitators to exercise in
participants diagnosed with MODY.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge about exercise in patients diagnosed with maturity onset diabetes of young |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/11/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sabhaanjum453@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The MODY is a disease suffered by the young population and which is the bread winner population of the society and engaging in time intensive physical activity may be a challenge the stress levels and the family responsibilities may take priority over health. This not only increases the challenges to manage but affect the entire family, thus society and becomes a problem of National interest. The reasons for looking into the factors that encourage and hinder people with MODY to engage in physical activity may be numerous and emphasizes the need to deal with the unique difficulties that this particular group of people face. The role of exercises in the management of MODY are rarely understood, though the previous data suggests that exercise have proven immensely helpful and are recommended as first line of management in type 1 and type 2 diabetes and has shown to have short term as well as long term effect on management of blood glucose level thus preventing the future complications and improving the quality of life of diabetics. But the challenges faced by individuals with MODY are not studied markedly and with alarming increase in prevalence of MODY in India it became imperative to study the challenge faced by the individuals with MODY to participate in exercise and also what are the perceived facilitators for the same. |