| CTRI Number |
CTRI/2024/06/069575 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assess physical activity level and to find awareness among Indian |
|
Scientific Title of Study
|
Assessing Physical Activity Level Of Adults Using International Physical Activity Questionnaire (IPAQ): Cross-Sectional 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 |
Sriya Gupta |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Gujarat University |
| Address |
Physiotherapy Department, Ahmedabad Institute of Medical Science, (AIMS) College, Lapkaman, Ahmedabad
Ahmadabad
GUJARAT
380062
India |
| Phone |
9737802468 |
| Fax |
|
| Email |
shriyagupta872@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sriya Gupta |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Gujarat University |
| Address |
Physiotherapy Department, Ahmedabad Institute of Medical Science,(AIMS) College, Lapkaman, Ahmedabad
Ahmadabad
GUJARAT
380062
India |
| Phone |
9737802468 |
| Fax |
|
| Email |
shriyagupta872@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hardini B Prajapati |
| Designation |
MPT , Associate Professor |
| Affiliation |
Gujarat University |
| Address |
Physiotherapy Department, Ahmedabad Institute of Medical Sciences College of Physiotherapy
Ahmadabad
GUJARAT
380062
India |
| Phone |
9898550634 |
| Fax |
|
| Email |
drhardini@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy department, Ahmedabad Institute of Medical Science, Lapkaman, Gota-Vadsar, Ahmedabad, Gujarat India 380060 |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Institute of Medical Science |
| Address |
AIMS College , Lapkaman , 380062 Ahmedabad |
| Type of Sponsor |
Private medical college |
|
|
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 Sriya M Gupta |
AIMS |
Physiotherapy department Ground Floor , AIMS College , Lapkaman , 380062 Ahmedabad
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
8780482138
shriyagupta872@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ahmedabad Institute of Medical Science, Research and Ethics Committee, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E660||Obesity due to excess calories, (3) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) Men/Women of young age and middle age (18 – 65 years).
(2) Willing to participate.
(3) With and without HTN
(4) With and without Diabetic |
|
| ExclusionCriteria |
| Details |
People with acute illnesses, people who are deaf or mute or have other
communicable disease, people who have had recent surgery |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Level of Physical Activity Level
2. MET Value
3. Level of Awareness |
Baseline data.
All the outcome measures Will be measured on the same day of survey.
3. Level of Awareness |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Blood Pressure
2. BMI |
Baseline data.
All the outcome measures Will be measured on the same day of survey. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
05/07/2024 |
| 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="6"
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shriyagupta872@gmail.com].
- For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The purpose of this study is to present data on the prevalence of physical activity also to investigate the association of physical activity with various other domains such as BMI, Age, Gender and other risk factors. Such data are valuable for the cross-national assessment of the prevalence of physical activity in the Indian population and can assist policy makers and public health experts in developing strategies for the promotion of physical activity. This study will allow a comparison of days of vigorous and moderate physical activity, walking, and the calculation of metabolic equivalent. The aim of the study is to determine physical activity levels in a representative sample of population, using the long form International Physical Activity Questionnaire (IPAQ) and to find awareness of the same using a questionnaire. Sample size: 500 Adults Methodology: Each individual will be asked to fill up the questionnaire and the collected information will be used to analyze the level of Physical Activity. Also the data will be further corelated to find out the relation between Level Of Physical Activity with factors such as Diabetes, Hypertension, knowledge and awareness of physical activity. |