Effects of Back Squat Exercise with or Without Blood Flow Restriction in Healthy Adolescent Basketball Athletes

NCT06684093 | Completed DMC FDA Device

• 1 other identifier: 2023-325
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effectiveness of Blood Flow Restriction (BFR) training compared to traditional high-intensity training in adolescent basketball players aged 16-18. The main questions it aims to answer are: Does BFR training improve muscle strength more effectively than traditional high-intensity training? Does BFR training enhance jump height and ground reaction force (GRF) while reducing mechanical load? Researchers will compare BFR training to traditional high-intensity training to see if BFR training offers greater improvements in muscle strength, jump height, and GRF while potentially reducing knee joint stress. Participants will: Be randomly assigned to either the BFR training group or the high-intensity training group. Undergo performance evaluations, including measurements of muscle strength, jump height, and GRF at three time points throughout the study. Follow a training protocol specific to their assigned group

Conditions

Adolescent Athletic Performance; Muscle Strength Development; Jump Height Improvement; Ground Reaction Force (GRF) Enhancement; Injury Prevention in Sports; Blood Flow Restriction (BFR) Training Effects; Reduced Mechanical Load on Joints

Keywords

Blood Flow Restriction training; high intensity training; basketball; injury prevention; jump height; ground reaction force

Outcome Measures

Primary Outcomes (1)

• Quadriceps Muscle strength (Kg)

  Assessed using a digital dynamometer, this measure reflects the improvement in quadriceps strength, a key indicator of the effectiveness of low-intensity training with BFR.

  Baseline (Day 0, before starting the protocol), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).

Secondary Outcomes (3)

• Hamstring Muscle Strength (kg)

  Baseline (Day 0, before starting the protocol), 3 weeks after the baseline assessment (Day 21), and 48 hours after the last session, approximately 6 weeks after the baseline assessment (Day 42).

• Jump Height (cm)

  Baseline (Day 0), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).

• Ground reaction force (Newton)

  Baseline (Day 0), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).

Other Outcomes (3)

• 1RM (One Repetition Maximum) (kg)

  Baseline (Day 0), 3 weeks after baseline (Day 21), and 48 hours after the last session, approximately 6 weeks after baseline (Day 42).

• Occlusion Pressure (mmHg)

  Pre-exercise on Day 0 (Baseline).

• Inter-Rater Reliability (ICC)

  Throughout the duration of the study (up to 6 weeks).

Study Arms (2)

Back Squat Exercise without Blood Flow Restriction

ACTIVE COMPARATOR

In this arm of the study, participants will perform back squat exercises without any blood flow restriction. This group serves as a control to evaluate the effects of traditional resistance training alone on strength and muscle development in healthy adolescent basketball athletes.

Behavioral: Back squats

Back Squat Exercise with Blood Flow Restriction

EXPERIMENTAL

This arm of the study involves participants performing back squat exercises while blood flow restriction is applied to the upper legs. The aim is to assess the effects of combining traditional resistance training with blood flow restriction on strength and muscle hypertrophy in healthy adolescent basketball athletes.

Device: Back squat with Blood flow restriction machine

Interventions

Back squat with Blood flow restriction machine DEVICE

The blood flow restriction (BFR) machine is a specialized device designed to safely apply controlled pressure to the proximal limbs during exercise. It typically consists of adjustable cuffs or bands that are placed around the upper arms or thighs, which are connected to a pressure monitoring system. The device enables practitioners to restrict venous blood flow while allowing arterial blood flow to the working muscles. This method enhances the effects of low-intensity resistance training by promoting muscle hypertrophy and strength gains, similar to those achieved through high-intensity training. The BFR machine is commonly used in rehabilitation settings and athletic training programs to optimize performance and recovery while minimizing the risk of injury.

Back Squat Exercise with Blood Flow Restriction

Back squats BEHAVIORAL

Back squats without any blood flow restriction

Back Squat Exercise without Blood Flow Restriction

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 16 and 18 years.
• Engaged in basketball training sessions at least three times per week.
• Competed in basketball within the last six months.
• No major injuries that limit their training session routines.

You may not qualify if:

• History or presence of cardiac, pulmonary, or metabolic conditions.
• Presence of vascular disorders in the upper or lower limbs.
• Individuals with coagulation disorders or those undergoing anticoagulant therapy.
• Recent surgeries or chronic conditions contraindicating Blood Flow Restriction (BFR) training.

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Two sports academies in Lebanon (Mont la salle and Rebound academies)

Beirut, Lebanon

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, only the Outcomes Assessor is masked to the group assignments. The assessors responsible for measuring muscle strength, jump height, and ground reaction force (GRF) are unaware of which participants belong to the Blood Flow Restriction (BFR) training group or the traditional high-intensity training group. This masking aims to minimize bias during the evaluation and analysis of performance outcomes. The participants, care providers, and investigators are aware of the group assignments, as they are directly involved in the delivery and participation in the specific training protocols.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Model Details: The study uses a Parallel Assignment model where participants are randomly assigned to one of two intervention groups. Group 1: Blood Flow Restriction (BFR) Training Group - Participants engage in low-load resistance training (20-30% of 1-repetition maximum) with blood flow restriction applied to the working muscles using pressure cuffs. The training focuses on strengthening the quadriceps, hamstrings, and calf muscles. Group 2: Traditional High-Intensity Training Group - Participants perform high-intensity resistance exercises (70-85% of 1-repetition maximum) targeting the same muscle groups as the BFR group. Both groups undergo the respective training protocols three times a week over 8-12 weeks. Performance outcomes, including muscle strength, jump height, and ground reaction force (GRF), are measured at baseline, mid-intervention, and post-intervention. The parallel assignment allows a direct comparison of the effects of BFR training versus traditional high-intensity training on

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 12, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

LE (1)