KneeNCT05924698
Blood Flow Restriction Therapy Combined With Neuromuscular Electrostimulation in Amateur Female Soccer Players
A study testing Electrostimulation and Blood flow restriction therapy in people with Knee, run by Universidad de Extremadura at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knee
- What is being tested?
- Electrostimulation and Blood flow restriction therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2023to 13 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 28 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Contraceptive intake.
- Spinal radicular lesions.
- Previous surgeries related to the circulatory system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Blood Flow Restriction Therapy Combined With Neuromuscular Electrostimulation in Amateur Female Soccer Players: A Pilot Study
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.
Read the detailed description
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.
For this purpose, a randomized clinical trial will be performed: 20 amateur female soccer players were distributed in two groups (control group n=10; experimental group n=10). In the control group, NMES (symmetrical biphasic rectangular pulse, 350 μs and 80Hz) combined simultaneously with active exercise in knee extension (75 repetitions in 4 sets, 20% 1RM, 30 seconds rest between sets) was applied. The experimental group performed the same intervention combined with blood flow restriction (BFR) therapy (80% of arterial occlusion pressure). The variables measured were muscle strength, muscle volume and static proprioception.
- Conditions
- Knee
- Being tested
- Electrostimulation, Blood flow restriction therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrostimulationOther
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.
Blood flow restriction therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This arm only received the Neuromuscular and Muscular Electrical Stimulation (NMES) intervention. Receives: Other: Electrostimulation |
| Experimental group | Experimental | This arm received the intervention with NMES and Blood flow restriction (BFR). Receives: Other: Electrostimulation; Other: Blood flow restriction therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the intervention, at day 1
Secondary outcomes (1)
Knee joint repositioning
It was performed through the ability to perceive and reproduce an articular angle previously represented and explained passively. The angles are photographed and measured using the SAPO® computer program, by means of the placement of four marked points on the greater trochanter, lateral epicondyle of the femur, head of the fibula and peroneal malleolus. To perform this procedure, the user must memorize two positions, knee flexion of 90º and knee flexion of 135º, taking 3 photographs of each position in both seated and prone positions.
Measured: During the intervention, at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start15 Apr 2023
- Primary completion15 Apr 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Fernández-Morales, Universidad de Extremadura
- Investigators
- Luis Espejo-Antúnez, Ph.D., Study director, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924698
- Sponsor's protocol ID
- 04
- Status last verified
- Dec 2023
- First submitted
- 13 Jun 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Therapy Combined With Neuromuscular Electrostimulation in Amateur Female Soccer Players: A Pilot Study
- ClinicalTrials.gov ID
- NCT05924698
- Acronym / sponsor ID
- 04
- Conditions
- Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
For this purpose, a randomized clinical trial will be performed: 20 amateur female soccer players were distributed in two groups (control group n=10; experimental group n=10). In the control group, NMES (symmetrical biphasic rectangular pulse, 350 μs and 80Hz) combined simultaneously with active exercise in knee extension (75 repetitions in 4 sets, 20% 1RM, 30 seconds rest between sets) was applied. The experimental group performed the same intervention combined with blood flow restriction (BFR) therapy (80% of arterial occlusion pressure). The variables measured were muscle strength, muscle volume and static proprioception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: ElectrostimulationThis arm only received the Neuromuscular and Muscular Electrical Stimulation (NMES) intervention. |
| Experimental group | Experimental | Other: Electrostimulation, Other: Blood flow restriction therapyThis arm received the intervention with NMES and Blood flow restriction (BFR). |
Who may qualify
- Ages
- 16 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrostimulationConsisting 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. | Other | Control group, Experimental group |
| Blood flow restriction therapyTo 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. | Other | Experimental group |
Primary outcome
Muscular Strenght
Time frame: During the intervention, at day 1
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.
Muscle volume
Time frame: During the intervention, at day 1
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.
1 secondary outcome
Knee joint repositioning
Time frame: During the intervention, at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruitingObservational study
Isokinetic Knee Strength, Bilateral Muscle Balance, and Anaerobic Performance in Adolescent Athletes
Isokinetic Knee Strength, Hamstring-to-Quadriceps Strength Ratio
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Espejo-Antúnez, Ph.D. study director
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrostimulation and Blood flow restriction therapy in people with Knee, run by Universidad de Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular Strenght (time frame: During the intervention, at day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.