| CTRI Number |
CTRI/2024/09/074360 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [BLOOD FLOW RESTRICTION THERAPY] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
How High-Intensity Jumping with Blood Flow Bands Affects Basketball Players Jumping and Quickness |
|
Scientific Title of Study
|
Evaluating the impact of High-intensity jump exercises with Blood Flow Restriction among jump Performance and Agility among Basketball 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 |
Chhaya adwani |
| Designation |
MPT Sports student |
| Affiliation |
SRM College of physiotherapy SRM institute of science and technology |
| Address |
Room no PT05 5th floor SRM college of physiotherapy SRM medical college hospital and research center SRM nagar Potheri Kattankulathur Kancheepuram
Kancheepuram TAMIL NADU 603203 India |
| Phone |
7304610303 |
| Fax |
|
| Email |
ca1771@srmist.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. M. Manikumar |
| Designation |
PhD, MPT Sports, Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
SRM College of Physiotherapy, SRM Medical College Hospital and Research Center, SRM nagar, Potheri, Kattankulathur Kancheepuram, Chennai
Kancheepuram TAMIL NADU 603203 India |
| Phone |
8939164922 |
| Fax |
|
| Email |
manikumm@srmist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Chhaya adwani |
| Designation |
MPT Sports student |
| Affiliation |
SRM College of physiotherapy SRM institute of science and technology |
| Address |
Room no PT05 5th floor SRM college of physiotherapy SRM medical college hospital and research center SRM nagar Potheri Kattankulathur Kancheepuram
Kancheepuram TAMIL NADU 603203 India |
| Phone |
7304610303 |
| Fax |
|
| Email |
ca1771@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRM Institute of Science and Technology, Potheri, Kattankulathur, Chennai, 603203 |
|
|
Primary Sponsor
|
| Name |
CHHAYA ADWANI |
| Address |
Room no PT05 5th floor SRM college of physiotherapy SRM medical college hospital and research center SRM nagar Potheri Kattankulathur Kancheepuram Tamilnadu 603203 |
| Type of Sponsor |
Other [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 |
| CHHAYA ADWANI |
SRM College of Physiotherapy, SRMIST, kattankulathur, Chennai |
SRM Valliammai sports ground, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur. Kancheepuram TAMIL NADU |
7304610303
ca1771@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDCICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY ATHLETES |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HIGH INTENSITY JUMP EXERCISE WITH BLOOD FLOW RESTRICTION |
After the selection of participants using inclusion and exclusion criteria the pre assessment will be taken for both experimental and control group and then the experimental group alone will receive blood flow restriction training with a frequency of 2 times a week for 6 weeks after the period of training, post assessment will be taken after 6 weeks and with the values of pre and post-test we will be able to know the effectiveness of intervention. |
| Comparator Agent |
ROUTINE PROTOCOL |
They will be doing their regular practice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Male basketball players
Age group 18-25
Players with minimum 2 years of experience
|
|
| ExclusionCriteria |
| Details |
Players with a history of cardiovascular disease, hypertension, coagulation disorders
Players with current injuries that could be aggravated by high-intensity jump exercises or BFR
Peripheral vascular disease Cancer or Tumor.
Any recent surgeries.
Any soft tissue injuries
Players who are not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vertical jump test, Agility T-test |
Before and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1RM of leg extension, BORG CR10 SCALE |
BORG CR10 SCALE- during exercise session, 1RM of leg extension- Before and after intervention
|
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
31/12/2024 |
| 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="0" Months="6" 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
|
Players
will be evaluated based on inclusion and exclusion criteria.
Players
were
randomly divided into 2 groups by the method of drawing lots by someone
unrelated to the study.
Plyometric group
performed a relevant progressive exercise program and BFR group performed the
same exercise program combined with BFR application. The duration of the
intervention was 6weeks
with
a twice per week frequency. The intervention took place in
the SRM college of physiotherapy sports lab, after
warming up and before recovery. The test variables were measured before the intervention, and
after the end of the intervention. The plyometric
exercise program lasted 6
weeks
and was divided into 2 progressive
phases. The first phase lasted 3
weeks, the
second 3 weeks.
There was progression in all exercises, both in the ground contact and the
level of difficulty and skill. Each
week the sets or repetitions increased, while in each phase the difficulty in
the exercises increased, too. In the first phase there were bipedal exercises,
in the second phase an obstacle was added to the bipedal exercises and unipodal
exercises were introduced. In the third and last phase, an obstacle was added
to the one-legged exercises and the height of the obstacle in the two-legged
exercises was increased. The
eligible participants will be given a written explanation of the study’s
objectives before providing their written informed consent form. The athletes
will be randomly assigned to either a BFR group A(n=17) and non-BFR group
B(n=17). Before starting with the training session, the vertical jump performance, quadriceps muscle strength and agility of each athlete will be recorded using
1RM of leg extension, vertical jump test and agility T- test.Blood
flow restriction training guidelines will be followed for Group A (BFR group)
while performing exercises. Upon
arrival at each testing session, in BFR group participants’ blood pressure will
be measured in seated position. Group A participants will be comprehensively
familiarized with BFR protocol a BFR cuff will be placed on both legs at the
upper third of the thigh, below the gluteal line. Then
each participant will do moderate intensity exercise which is between 4-6 on
rate of perceived exertion scale. If any participant is facing any difficulty
during or while completing the exercise session, then they can discontinue that
particular session. The exercise program of the first week was piloted in two groups (without BFR and with BFR)
one week prior to the intervention so that the participants become familiar
with the intervention process, the application of BFR as well as for ensuring
the appropriate level of difficulty of the exercise regime. They were also
asked to rate the difficulty of each exercise on the Borg CR10 scale (>4
scored exercises were acceptable), to ensure an above average difficulty in the
prescribed exercises. In the
BFR group, the Fitcuffs
system (Fit Cuffs ApS,
Odder, Denmark) consisting of 10 cm wide nylon cuffs with manual inflation and
a manometer were used to control the pressure applied. The cuffs were placed on both legs at the upper third of the thigh, below the
gluteal line. The application of pressure was done in the upright position
until it reached 100 mmHg. During the breaks, the pressure was checked and
adjusted to 100 mmHg.The
high
intensity jump exercise program will start from a standardized warm-up, which
will include running at increasing speed, as well as dynamic stretches lasting
approximately 10 minutes. The Physical training sessions will be on two
non-consecutive weekdays for 6 weeks. Training volume will be defined based on
number of jumps, which will gradually raise each week. In all training
sessions, the jump exercises progressed in intensity and complexity from week 1
to week 6. Rests between sets and exercise comprehended 30 and 120 seconds,
respectively. |