Blood Flow Restriction Therapy Combined With Neuromuscular Electrostimulation in Amateur Female Soccer Players

NCT05924698 | Completed

• 1 other identifier: 04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to know the effects of Neuromuscular Electrical Stimulation (NMES) and its combination with Blood Flow Restriction (BFR) Therapy in healthy amateur female soccer players.

Conditions

Knee

Outcome Measures

Primary Outcomes (2)

• Muscular Strenght

  It was performed using an isokinetic dynamometer (Kineo, Globus, Codognè, Italy). The maximum peak force that the user can perform was measured by means of the concentric-eccentric isokinetic force test. The patient is placed seated on the seat of the machine and with the dominant lower limb, performs 5 contractions with the maximum force, obtaining the concentric and eccentric peak force.

  During the intervention, at day 1

• Muscle volume

  It was performed by means of the thigh perimeter, using a tape measure. The superior pole of the patella is selected as an anatomical reference point and four segments are marked from it, located at 5, 10, 15 and 20 centimeters respectively (95). Subsequently, placing the beginning of the measuring tape at the mark of the segment in question, the thigh is encircled keeping the beginning of the tape fixed, which will coincide with a measurement of the tape when it is reached. This measurement is taken before the start of the quadriceps work with the knee extension exercise and at the end of the 15 minutes of rest after this work.

  During the intervention, at day 1

Secondary Outcomes (1)

• Knee joint repositioning

  During the intervention, at day 1

Study Arms (2)

Control group

ACTIVE COMPARATOR

This arm only received the Neuromuscular and Muscular Electrical Stimulation (NMES) intervention.

Other: Electrostimulation

Experimental group

EXPERIMENTAL

This arm received the intervention with NMES and Blood flow restriction (BFR).

Other: Electrostimulation; Other: Blood flow restriction therapy

Interventions

Electrostimulation OTHER

Consisting of the use of NMES (biphasic symmetrical pulse, bipolar mode, 50Hz frequency, pulse duration 300 μs at 1:1 ratio) (S82®; Enraf-Nonius BV, Rotterdam, The Netherlands). The self-adhesive electrodes (8x5 cm2 Pals Platinum © type, Axelgaard Manufacturing Co. Ltd, Fallbrook, CA, USA) were placed on the quadriceps muscle. The positives electrodes placed distally on the rectus anterior and vastus externus and negative electrodes were placed proximally on the rectus anterior and vastus internus. The over current program consisted of 8 seconds (s) of work (ON phase) and 8 seconds of rest (OFF phase). The overcurrent program in the ON phase had a rise time of 2 s, a hold time of 4 s and a fall time of 2 s. The intensity of the electric current was increased to the maximum perceived tolerance, achieving a clear contraction without producing fatigue.

Control group; Experimental group

Blood flow restriction therapy OTHER

To attain partial vascular occlusion, a PTS ii portable tourniquet system (Delphi Medical, Vancouver, BC, Canada) with a corresponding size-specific tourniquet was placed around the patient's proximal thigh. This system allows for precise control of cuff pressure throughout training despite the changes in muscle volume that naturally occur while performing exercises. Total limb occlusion pressure (LOP) was identified by determining the pressure required to eliminate a detectable pulse using Doppler ultrasound. Partial vascular occlusion was achieved by setting the tourniquet to 80% of the LOP. This ensured that venous occlusion was obtained while still allowing arterial inflow and was personalized to each patient despite variations in thigh girth, cuff size, and systolic blood pressure. An Easy-Fit Tourniquet Cuff (Delfi Medical, Vancouver, VC, Canada) was used with the PTS ii system.

Experimental group

Eligibility Criteria

• Age: 16 Years - 28 Years
• Gender Eligibility Details: Amateur 11-a-side soccer players
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be federated in a sports club playing 11-a-side soccer for at least the last two seasons.
• Be between 16 and 28 years of age.
• Be physically active players at the time of the study with a regular practice of at least 5 hours per week during the last 2 months,
• Have been playing soccer for at least 5 hours per week during the last 2 months.
• Have been playing soccer for at least 2 years

You may not qualify if:

• Those who presented at the time of the study any lesion classified according to the Munich consensus and diagnosed by a doctor.
• Those with systemic lupus erythematosus.
• Hemophilia.
• Unregulated hypertension.
• History of pulmonary thromboembolism or stroke.
• Impaired blood coagulation.
• Contraceptive intake.
• Spinal radicular lesions.
• Previous surgeries related to the circulatory system.

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

University of Extremadura

Badajoz, 06006, Spain

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation; Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Luis Espejo-Antúnez, Ph.D.

  University of Extremadura

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 29, 2023
• Study Start: April 15, 2023
• Primary Completion: April 15, 2023
• Study Completion: June 13, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)