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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.

 
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