| CTRI Number |
CTRI/2026/02/103642 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To compare adverse event associated with blood flow restriction training and flossband technique in Upper-Extremity DOMS Among Collegiate Athletes |
|
Scientific Title of Study
|
Comparison of Adverse Events Associated with Blood Flow Restriction Training and Floss Band Technique in Upper-Extremity Delayed Onset Muscle Soreness Among Collegiate Athletes |
| 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 Irshad Ahmad |
| Designation |
Assistant professor |
| Affiliation |
Manav Rachna International Institute Of Research And Studies |
| Address |
Department of Physiotherapy, Manav Rachna International Institute Of Research And Studies, Faridabad, Haryana 121010
Faridabad
HARYANA
121010
India |
| Phone |
9911878341 |
| Fax |
|
| Email |
irshad.sahs@mriu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pracheta Pandit |
| Designation |
PG Student |
| Affiliation |
Manav Rachna International Institute Of Research And Studies |
| Address |
QS-11, Q block, Department of Physiotherapy, Manav Rachna International Institute Of Research and Studies, Faridabad, Haryana 121010
Faridabad
HARYANA
121010
India |
| Phone |
8668816486 |
| Fax |
|
| Email |
panditpracheta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Irshad Ahmad |
| Designation |
Assistant professor |
| Affiliation |
Manav Rachna International Institute Of Research And Studies |
| Address |
Department of Physiotherapy, Manav Rachna International Institute Of Research and Studies, Faridabad, Haryana 121010
Faridabad
HARYANA
121010
India |
| Phone |
9911878341 |
| Fax |
|
| Email |
irshad.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute Of Research And Studies Department of Physiotherapy Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121010
|
|
|
Primary Sponsor
|
| Name |
Pracheta Pandit |
| Address |
402 Rajashree tower Rambaug lane no 6 Murbad Road Kalyan West -421301 |
| 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 Irshad Ahmad |
Manav Rachna International Institute Of Research And Studies |
Department of Physiotherapy, Manav Rachna International Institute Of Research and Studies, Faridabad, Haryana 121010
Faridabad
HARYANA |
09911878341
irshad.sahs@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental ethical commitee, department of physiotherapy,Manav Rachna International Institute Of Research And Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Compare Adverse Events Associated with Blood Flow Restriction Training and Floss Band Technique in Upper-Extremity Delayed Onset Muscle Soreness |
To compare Adverse Events Associated with Blood Flow Restriction Training and Floss Band Technique in Upper Extremity Delayed Onset Muscle Soreness Duration of study 4 days (baseline data collected followed by data collection at 0hr,24hr,48hr,72 hr) |
| Intervention |
Compare Adverse Events Associated with Blood Flow Restriction Training and Floss Band Technique in Upper-Extremity Delayed Onset Muscle Soreness |
to compare Adverse Events Associated with Blood Flow Restriction Training and Floss Band Technique in Upper-Extremity Delayed Onset Muscle Soreness Duration of study 4 days (baseline data collected followed by data collection at 0hr,24hr,48hr,72 hr) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Age criteria 18 years to 26 years with no signifciant medical condition no upper body injuries and those able and willing to sign written consent form and and comply with all study procedures |
|
| ExclusionCriteria |
| Details |
Those with known cvs diseases and history of thromboembolism and neuromuscular diseases skin diseases and active infections will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Likert Scale of Muscle Soreness ,Range of motion using - universal goniometer , Muscle Girth using circumferential tape, Endurance (plank to alternate shoulder taps, Strength (chin-ups), Power (seated medicine ball throw , Speed (bicep curl), and Balance (YBT-UQ) |
baseline and at 0hr, 24hr,48hr,72hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
23/02/2026 |
| 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="4"
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 PROTOCOL WAS APPROVED BY THE RESEARCH ETHICAL COMMITTEE-SCHOOL OF ALLIED HEALTH SCIENCES, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD. ALL THE PARTICIPANTS WILL BE MADE TO SIGN THE WRITTEN INFORMED CONSENT PRIOR TO PARTICIPATION IN THE STUDY. THE PARTICIPANTS FROM THE DEPARTMENT OF PHYSIOTHERAPY WILL BE IDENTIFIED. FOLLOWING IDENTIFICATION OF THE PARTICIPANTS, MATCHING INCLUSION AND EXCLUSION CRITERIA WILL BE SELECTED. A TOTAL OF 66 SUBJECTS, BY SAMPLING USING RANDOMISATION, WILL BE DONE AND THE PARTICIPANTS WILL BE ASSIGNED RANDOM SINGLE TABLES INTO THREE GROUPS . GROUP A WILL BE 22 PARTICIPANTS PERFORMING BFRT . GROUP B WILL BE 22 PARTICIPANTS PERFORMING FLOSS BAND TECHNIQUE, AND GROUP C WILL BE 22 IN THE CONTROL GROUP. THE OUTCOMES WILL BE MEASURED AT 5 DIFFERENT TIME POINTS, WHICH ARE AT BASELINE AND AT 0HR,24HR,48HR AND 72 HR FOR MUSCLE SORENESS, RANGE OF MOTION, AND MUSCLE GIRTH, AND PHYSICAL PERFORMANCE MEASURES – ENDURANCE, POWER, STRENGTH, AND BALANCE. THE FINAL READING WILL BE TAKEN AFTER COMPLETION OF INTERVENTION . |