| CTRI Number |
CTRI/2023/09/058076 [Registered on: 27/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison of different types of compression garments on performance of athletes |
|
Scientific Title of Study
|
Comparison of different types of compression garments on physiological, psychological and performance parameters in sprinters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishan Gupta |
| Designation |
pg student |
| Affiliation |
College of Physiotherapy, Pt. B. D. SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK |
| Address |
College of Physiotherapy, Pt. B. D. SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
8607921214 |
| Fax |
|
| Email |
ishu001gupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Singh Yadav |
| Designation |
Assistant professor |
| Affiliation |
College of Physiotherapy, Pt. B. D. SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK |
| Address |
College of Physiotherapy, Pt. B. D. SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9466441234 |
| Fax |
|
| Email |
vikramsinghyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Singh Yadav |
| Designation |
Assistant professor |
| Affiliation |
College of Physiotherapy, Pt. B. D. SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK |
| Address |
College of Physiotherapy, Pt. B. D. SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9466441234 |
| Fax |
|
| Email |
vikramsinghyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D.SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy PGIMS Rohtak |
| Address |
Pt. B. D. SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK |
| Type of Sponsor |
Government 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 Vikram singh yadav |
Pt. B.D SHARMA, PGIMS/UHS |
College of Physiotherapy, Pt. B. D. SHARMA POST GRADUATE INSTITUTE OF MEDICAL SCIENCE , ROHTAK
Rohtak
HARYANA |
9466441234
vikramsinghyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| biomedical research ethics committee, Pt. B.D. Sharma PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
sprinters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
different types of compression garments |
comparison of different types of compression garments in 400 meters sprinting.
single repitation, single time sprinting, for 4 consecutive days |
| Intervention |
intervention with compression garments |
400m sprint with short compression garment
400m sprint with long compression garment
400m sprint with combination of calf sleeves and short compression garment
single repitation, single time sprinting, for 4 consecutive days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
people who is willing to participate
district level male athlete with a minimum of 2 years of training specific to 400m running
age group 18-30 years
no recent lower limb injuries within last 6 months |
|
| ExclusionCriteria |
| Details |
smoker, chronic alcoholic or uses ergonomic aids
athlete suffering from an injury in the last 6 months
any cardiac or respiratory disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
heart rate, respiratory rate, body temperatue
blood lactate
blood glucose
anxiety
self esteem
comfort
balance
agility
|
at day 1
at day 2
at day 3
at day 4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
blood pressure
rate of percieved exertion
sprint speed
knee joint proprioception |
at day 1
at day 2
at day 3
at day 4 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 1 |
|
Date of First Enrollment (India)
|
15/10/2023 |
| 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 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
|
comparison of different types of compression garments on physiological ,psychological, and performance parameters in sprinters. 10 sample size |