| CTRI Number |
CTRI/2022/02/040507 [Registered on: 22/02/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physical Activity levels and gait speed in aging population |
|
Scientific Title of Study
|
Physical Activity levels and gait speed in aging population in Belagavi city-An Observational 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 |
Dr Pratheeksha Kamath |
| Designation |
Lecturer |
| Affiliation |
KAHER Institute of Physiotherapy. |
| Address |
Room no 39, advance physiotherapy center,Sagar floor KLE Dr Prabhakar Kore hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
6362462770 |
| Fax |
|
| Email |
pratheeksha1802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratheeksha Kamath |
| Designation |
Lecturer |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Room no 39, advance physiotherapy center,Sagar floor KLE Dr Prabhakar Kore hospital and MRC, Belagavi
KARNATAKA
590010
India |
| Phone |
6362462770 |
| Fax |
|
| Email |
pratheeksha1802@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vardhaman Baligar |
| Designation |
Intern |
| Affiliation |
KAHER Institute of Physiotherapy. |
| Address |
Room no 39, advance physiotherapy center,Sagar floor KLE Dr Prabhakar Kore hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8073478212 |
| Fax |
|
| Email |
vardhamanbaligar78@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore hospital |
|
|
Primary Sponsor
|
| Name |
Akshata Pawar |
| Address |
Room no 39 advanced physiotherapy center, Sagar floor KLE Dr Prabhakar Kore hospital and MRC Belagavi |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Vardhamanbaligar |
KLE Dr Prabhakar Kore Hospital |
Room no 39, Advance Physiotherapy centre Sagar floor. KLE Dr Prabhakar Kore hospital Belagavi
Belgaum
KARNATAKA |
807378212
vardhamanbaligar78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and scientific committee.KAHER Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Aging population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who have Ability to comprehend and communicate and Individuals willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Participants with lower limb musculoskeletal injuries or deformities,Complete visual or hearing impairments,Those requiring assistive devices for walking,Uncontrolled diabetes and hypertension,Participants diagnosed with any oncological condition,Participants who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global physical activity questionnaire. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 10mtr gait speed test |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="131"
Sample Size from India="131"
Final Enrollment numbers achieved (Total)= "272"
Final Enrollment numbers achieved (India)="272" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2022 |
| Date of Study Completion (India) |
12/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
131 Aged people of 55 to 75 years in the community will be recruited after voluntary consent .They would be assessed for physical activity using Global physical activity questionnaire and for gait speed using 10mtr gait speed test. The values obtained would be noted and further subjected to statistical analysis |