| CTRI Number |
CTRI/2025/03/082676 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sports Training] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Blood Flow Restriction and Ischemic Preconditioning with Complex Training on Fitness and Performance in District-Level Football Players |
|
Scientific Title of Study
|
Comparative analysis of blood flow restriction and ischemic preconditioning combined with complex training on bio motor performance in district-level football players |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anchal dhiman |
| Designation |
PG student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
faculty of physiotherapy
D-Block, Shree Guru Gobind Singh Tricentenary University
Chandu, Budhera,
Gurugram Haryana
Gurgaon HARYANA 122505 India |
| Phone |
8171987490 |
| Fax |
|
| Email |
anchaldhiman598@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sajjan Pal |
| Designation |
Associate Professor |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
faculty of physiotherapy
D-Block, Shree Guru Gobind Singh Tricentenary University
Chandu, Budhera,
Gurugram Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9468324923 |
| Fax |
|
| Email |
palsajjan14@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anchal dhiman |
| Designation |
PG student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
faculty of physiotherapy
D-Block, Shree Guru Gobind Singh Tricentenary University
Chandu, Budhera,
Gurugram Haryana
Gurgaon HARYANA 122505 India |
| Phone |
8171987490 |
| Fax |
|
| Email |
anchaldhiman598@gmail.com |
|
|
Source of Monetary or Material Support
|
| faculty of physiotherapy, D block, shree guru gobind singh tricentenary university, chandu, budhera, gurugram haryana |
|
|
Primary Sponsor
|
| Name |
Anchal dhiman |
| Address |
faculty of physiotherapy, D block, shree guru gobind singh tricentenary university, chandu, budhera, gurugram haryana |
| Type of Sponsor |
Other [principle investigator] |
|
|
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 |
| Anchal Dhiman |
SGT university |
faculty of physiotherapy, D block, shree guru gobind singh tricentenary university, chandu, budhera, gurugram haryana. Gurgaon HARYANA |
8171987490
anchaldhiman598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Faculty of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Flow Restriction Training With Complex training |
Participants in this group will perform complex training with blood flow restriction (BFR) applied using a pneumatic cuff on the proximal thigh at 20–30% of one-repetition maximum (1RM). Training will occur thrice weekly for four weeks, incorporating resistance (squats, split squats, deadlifts) and plyometric exercises(half jump squats, splits squats jump, squats jump). The BFR protocol includes 3 sets (15–20 reps) for resistance and 3sets(6-8 reps) for plyometrics with 30–45 seconds rest between sets and four minutes between exercises. The cuff remains inflated during each set and is deflated post-exercise. |
| Comparator Agent |
Complex training |
The control group will follow the same complex training program as the experimental groups but without blood flow restriction or ischemic preconditioning. Training will occur thrice weekly for four weeks, including squats, jump squats, split squats, split squats jump, deadlifts and squats jump at 20% 1RM for resistance and plyometric exercises. |
| Comparator Agent |
Ischemic Preconditioning (IPC) Group |
Participants in this group will undergo complex training preceded by ischemic preconditioning (IPC) as a warm-up. IPC involves three cycles of five-minute ischemia (200–220 mmHg) followed by five-minute reperfusion while seated. After IPC, participants will perform squats, jump squats, split squats, splits squats jump, deadlifts and squats jump at 20%-30% 1RM for resistance and plyometric exercises. Sessions will last 30 minutes with 3sets(15-20 reps) for resistance and 3sets(6-8reps) for plyometric four-minute rest intervals. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Players age between 18-25
2. Playing age 2 year
3. Players who are not involved in any research
4. Players who are practicing at least 3-5 days a week.
5. Players who have not had any injuries in the last six months.
|
|
| ExclusionCriteria |
| Details |
1.Players who have metabolic, cardiovascular and respiratory problems.
2.who have any kind of injury.
3.Players who have a history of surgical and musculoskeletal disorders.
4.Sever hypertension.
5.History of blood clots |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Dynamic balance (Y Balance test
2. Strength (1RM Back squat)
3. Core strength (Plank Test)
4. Power (Vertical Jump)
5. Muscular Grith of thigh (measuring tape) |
Day 1 Assessment and after 4th week assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Core strength (Plank Test)
2.Muscular Grith of thigh (measuring tape) |
Day 1 Assessment and after 4th week assessment |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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)
|
28/03/2025 |
| 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="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
|
Football is a physically demanding sport requiring a combination of strength, power, endurance, agility, and dynamic balance. To enhance athletic performance and reduce the risk of injuries, innovative training methods are continuously being explored. Among these, blood flow restriction training (BFRT) and ischemic preconditioning (IPC) combined with complex training have shown promising results in improving biomotor performance. However, limited research exists comparing these interventions in football players. This study aims to evaluate and compare the effects of BFRT and IPC integrated with complex training on strength, power, dynamic balance, core stability, and muscular hypertrophy in district-level football players. Understanding the effectiveness of these training methods will help optimize training strategies for enhanced athletic performance, injury prevention, and rehabilitation programs. BFRT is a novel training approach that involves applying a pneumatic cuff to the proximal thigh to partially restrict blood flow while performing low-load resistance (20–30% 1RM) and plyometric exercises. This method stimulates muscle fiber recruitment, metabolic stress, and anabolic hormone release, promoting muscular hypertrophy, strength, and endurance similar to high-intensity training. The advantage of BFRT lies in its ability to achieve significant strength and hypertrophy gains with reduced mechanical stress, making it particularly beneficial for athletes recovering from injuries and those seeking to enhance performance with lower training loads. IPC, on the other hand, is a vascular conditioning technique that involves three cycles of five-minute ischemia (200–220 mmHg) followed by five-minute reperfusion before training. This intervention has been shown to improve muscle oxygenation, vascular function, and metabolic efficiency, potentially leading to delayed fatigue, increased power output, and improved endurance. While IPC has been extensively studied in medical settings, its application in sports science is still emerging, and its direct effects on football performance remain unclear. Complex training is a widely recognized strength and conditioning method that combines resistance exercises (e.g., squats, jump squats, split squats, deadlifts) at 20% 1RM with plyometric movements (6–8 reps per set). This approach enhances neuromuscular efficiency and explosive strength through post-activation potentiation (PAP), making it highly effective for improving lower-limb power, agility, and reactive ability, which are essential in football. This study will be conducted as a randomized controlled trial (RCT) with 48 male football players (aged 18–25 years), divided into three groups: - BFRT Group: Participants will perform complex training with blood flow restriction.
- IPC Group: Participants will undergo ischemic preconditioning before complex training.
- Control Group: Participants will perform complex training without BFR or IPC.
All groups will train thrice per week for four weeks, with a standardized warm-up, structured exercise execution, and rest periods. Pre- and post-training assessments will evaluate dynamic balance (Y-Balance Test), strength (Weighted Squats), core stability (Plank Test), power (Vertical Jump Test), and muscular hypertrophy (Girth Measurements) to determine the impact of these interventions.
Study DesignThis randomized controlled trial (RCT) will randomly assigned into three groups. The BFRT group will perform complex training with blood flow restriction (20–30% 1RM) using a pneumatic cuff on the proximal thigh. The IPC group will undergo three cycles of five-minute ischemia (200–220 mmHg) followed by five-minute reperfusion before performing complex training. The control group will follow the same complex training without BFRT or IPC. Training will be conducted thrice a week for four weeks, incorporating resistance (squats, jump squats, split squats, deadlifts at 20% 1RM) and plyometric exercises (6–8 reps per set). Pre- and post-intervention assessments will measure dynamic balance (Y-Balance Test), strength (Weighted Squats), core stability (Plank Test), power (Vertical Jump Test), and muscular hypertrophy (Girth Measurements).Why This Study is ImportantDespite the known benefits of BFRT and IPC in various training and rehabilitation settings, their comparative effectiveness in football-specific training remains unexplored. Football players require high levels of power, endurance, and agility, and training strategies must be optimized to improve performance while minimizing injury risk. By integrating BFRT and IPC into complex training, this study seeks to determine whether these interventions provide additional benefits beyond traditional training methods. BFRT is particularly valuable in sports because it allows athletes to gain strength and hypertrophy with lower resistance, reducing joint and muscle strain. This is especially beneficial for injured athletes returning to play or those undergoing off-season conditioning. If proven effective, BFRT could be widely implemented in football training programs to enhance performance, support rehabilitation, and reduce injury risk. HypothesesNull Hypothesis - Blood Flow Restriction (BFR) and Ischemic Preconditioning (IPC) combined with complex training will have no significant effect on the sport-specific performance variables of district-level football players.
- There will be no significant difference between the effects of BFR and IPC, when integrated with complex training, on the sport-specific performance variables of district-level football players.
Alternate Hypothesis- Blood Flow Restriction (BFR) and Ischemic Preconditioning (IPC) combined with complex training will have a significant effect on the sport-specific performance variables of district-level football players.
- There will be a significant difference between the effects of BFR and IPC, when integrated with complex training, on the sport-specific performance variables of district-level football players.
|