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Muscle WeaknessNCT02443701

Light Therapy and Electrical Stimulation on Functional Performance in Volleyball Athletes

A study testing Exercise, LASER and NMES in people with Muscle Weakness and Sports Performance, run by Centro de Traumatologia do Esporte at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Volleyball players constantly perform vertical jumps, the higher the height of the jump is better sports performance of these players. Several methods have been tested to improve jumping performance in these players. Read more about this study

Who is it for?
Ages 17 to 18 years, men onlyHealthy volunteers can take part
Conditions the study is for
Muscle Weakness, Sports Performance
What is being tested?
Exercise, LASER and NMES
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteBrazil
Study dates
Jul 2015to Aug 2015
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 17 to 18 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy volunteers;
  • volleyball players;
  • gender male;
  • non-smoking;
  • aged between 17 and 18;
  • weight within 15% variation limit of normal weight for male athletes, taking into account height and physique.

Who cannot join

  • smoking volunteers;
  • history of alcohol or substance abuse;
  • diagnosis of cardiac, renal, gastrointestinal, hepatic, pulmonary, neurological, psychiatric, hematological or metabolic disorders; that are not available to participate in all stages of the study.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Ronaldo Alves da Cunha

    São Paulo, São Paulo, 04504000

Other trials in Brazil

About this study

Official title: Low Level Laser Therapy and Neuromuscular Electrical Stimulation on Knee Extension Strength and Jump in Volleyball Athletes: a Randomized Controlled Trial

Background: Volleyball players constantly perform vertical jumps, the higher the height of the jump is better sports performance of these players. Several methods have been tested to improve jumping performance in these players. It will be investigated the addition of electrical stimulation and phototherapy to jump training in volleyball athletes. DESIGN: randomized controlled trial. METHODS: This study will be conducted with 36 male athletes volleyball with minimum experience of 12 months sport. Will be randomized and assigned to 3 groups (control group, NEMES group and group phototherapy). All 36 healthy volleyball athletes who passed the initial selection and agreed to participate in the study, conduct a muscle strength and jump training program, which is held in both legs simultaneously. The 12 healthy athletes electrical stimulation group will perform the same training program described above, but strength training is associated with electrical stimulation. The 12 healthy athletes participating in the phototherapy group will undergo a phototherapy protocol before performing the strength and jump training. All selected participants will undergo an assessment of muscle strength of knee extensors and evaluate the jump. These evaluations were baseline, 6 weeks and 8 weeks after baseline.

Read the detailed description

Background: Volleyball players constantly perform vertical jumps, the higher the height of the jump is better sports performance of these players. Several methods have been tested to improve jumping performance in these players. It will be investigated the addition of electrical stimulation and phototherapy to jump training in volleyball athletes.

DESIGN: randomized controlled trial METHODS This study will be conducted with 36 male athletes volleyball with minimum experience of 12 months sport. Will be randomized and assigned to 3 groups (control group, NEMES group and group phototherapy).INTERVENTION All 36 healthy volleyball athletes who passed the initial selection and agreed to participate in the study, conduct a muscle strength and jump training program, which is held in both legs simultaneously. The training will be held in a period of six weeks with frequency of three times a week, totaling 18 training. The interval between one session and another will be 24 hours.

STRENGTH TRAINING To conduct the training all 36 healthy athletes, carry out heating in stationary bike for six minutes. After heating, the individuals are positioned in the extension machine with the knee joint positioned at 60 ° of flexion and hip at 75 ° flexion, which will perform 10 repetitions of maximal voluntary isometric contraction (MVIC), and the isometric contraction time will be 10 seconds and the rest time between repetitions of 30 seconds.

JUMPING TRAINING After the training the leg extension 36 individuals remain at rest for 5 minutes before starting the jump training. One type of jumps will be trained, countermovement jump (SCM). SCM in the participant will begin the movement of an upright standing position, with the knees fully extended, the volunteer will bend your knees up to about 90 ° before starting the movement up the jump. In each jump training individuals hold five sets of 10 repetitions with one minute intervals between each series.

ELECTRICAL STIMULATION The 12 healthy athletes electrical stimulation group will perform the same training program described above, but strength training is associated with electrical stimulation, medium frequency current (1kHz), Burst duration equal to 2ms with, modulated at 70Hz, cycle Work 10% T-on and T-10 seconds off and 30 seconds intensity used will vary according to the capacity and tolerable for each individual will be recorded for later analysis. The stimulated muscle group will be the quadriceps muscle, with two self-adhesive electrodes 8x13 cm (area of 104cm2). An electrode is placed in the rectus femoris muscle region with a distance of 20 cm from the anterior superior iliac crest and the other is positioned on the oblique vastus muscle region with a distance of 5 cm from the superior pole of the patella.

PHOTOTHERAPY The 12 healthy athletes participating in the phototherapy group will undergo a phototherapy protocol before performing the strength and jump training. Phototherapy will be conducted through a cluster with 03 diodes with 850nm wavelength and the following parameters: Power 50mW diode, diode energy by 2J, power per point of 6J, totaling 36J per member. The irradiation time is 40s by point in the continuous mode. The laser is applied in stationary manner in touch and perpendicular to the skin. The application sites will be six points on the belly of the quadriceps muscles bilaterally.

Evaluation and monitoring All selected participants will undergo an assessment of muscle strength of knee extensors and evaluate the jump. These evaluations were baseline, 6 weeks and 8 weeks after baseline.

The maximum isometric muscle strength of the knee extensors will be quantified using a hand dynamometer. To evaluate the ability of the jump was performed Jump and Reach Test. The maximum amount of countermovement jumps will be performed for 2 minutes. The overall impression will be assessed by scale of perceptation of the overall effect.

Being tested
Exercise, LASER, NMES
Medical subject headings
Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Also called Plyometric training

    Warmup program, maximum isometric strengthening, and jump training

  • LASEROther

    Also called Phototherapy

    a cluster with 03 diodes with 850nm wavelength and the following parameters: Power 50mW diode, diode energy by 2J, power per point of 6J, totaling 36J per member

  • NMESOther

    electrical stimulation, medium frequency current (1kHz), Burst duration equal to 2ms with, modulated at 70Hz, cycle Work 10% T-on and T-10 seconds off and 30 seconds intensity used will vary according to the capacity and tolerable for each individual

Study groups in NCT02443701
Study groupRoleWhat they receive
ExerciseExperimentalAll 12 volleyball athletes performed a strength training and jump, to be held in both legs at the same time. The training will be held in a six-week period, a total of 18 training. Athletes will hold a warmup in stationary bike for 6 minutes, maximum isometric strengthening in leg extension (knee positioned at 60 ° of flexion and hip in 75 ° of flexion), 10 repetitions of 10 seconds with 30 seconds interval. After strengthening conduct a complete rest 5 minutes and jump training countermovement in 5 sets of 10 jumps (1 minute interval between each jump).
Receives: Other: Exercise
NEMESExperimentalAll 12 volleyball athletes performed a strength training and jump, to be held in both legs at the same time. The training will be held in a six-week period, a total of 18 training. Athletes will hold a warmup in stationary bike for 6 minutes, maximum isometric strengthening in leg extension (knee positioned at 60 ° of flexion and hip in 75 ° of flexion), 10 repetitions of 10 seconds with 30 seconds interval. After strengthening conduct a complete rest 5 minutes and jump training countermovement in 5 sets of 10 jumps (1 minute interval between each jump).The healthy athletes electrical stimulation group will perform the same training program described above, but strength training is associated with electrical stimulation, medium frequency current (1kHz), modulated at 70Hz, cycle Work 10%, intensity used will vary according to the capacity and tolerable for each individua. The stimulated muscle group will be the quadriceps femoris
Receives: Other: Exercise; Other: NMES
PhototherapyExperimentalAll 12 volleyball athletes performed a strength training and jump, to be held in both legs at the same time. The training will be held in a six-week period, a total of 18 training. Athletes will hold a warmup in stationary bike for 6 minutes, maximum isometric strengthening in leg extension (knee positioned at 60 ° of flexion and hip in 75 ° of flexion), 10 repetitions of 10 seconds with 30 seconds interval. After strengthening conduct a complete rest 5 minutes and jump training countermovement in 5 sets of 10 jumps (1 minute interval between each jump). The 12 healthy athletes participating in the phototherapy group will undergo a phototherapy protocol before performing the strength and jump training. Phototherapy will be conducted through a cluster with 03 diodes with 850nm wavelength and the following parameters: Power 50mW diode, diode energy by 2J. The application sites will be six points on the belly of the quadriceps femoris muscles bilaterally.
Receives: Other: Exercise; Other: LASER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle strength measured by dynamometer

    The athletes will be evaluated in 3 phases: initial evaluation (pre-training), immediately after post-training, and a 8-wk follow up. It will be assessed the isometric muscle strength of knee extensors.

    Measured: 6 weeks

Secondary outcomes (3)
  1. Global impression measured by global perceived effect scale

    The athletes will be evaluated in 3 phases: initial evaluation (pre-training), immediately after post-training, and a 8-wk follow up. It will be assessed the global perceived effect scale about the jump.

    Measured: 6 weeks

  2. Jumping frequency measured by jumping frequency in 2 minutes

    The athletes will be evaluated in 3 phases: initial evaluation (pre-training), immediately after post-training, and a 8-wk follow up. It will be assessed Jumping frequency in 2 Minutes (countermovement jump)

    Measured: 6 weeks

  3. Jump ability measured by jump ability test

    The athletes will be evaluated in 3 phases: initial evaluation (pre-training), immediately after post-training, and a 8-wk follow up. It will be assessed the jump ability test.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2015
  4. Study completionAug 2015

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02443701
Sponsor's protocol ID
U1111-1169-4661
Status last verified
Aug 2015
First submitted
23 Apr 2015
Last updated
13 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Exercise, LASER and NMES in people with Muscle Weakness and Sports Performance, run by Centro de Traumatologia do Esporte at 1 site in Brazil.

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 6 inclusion and 3 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 13 Aug 2015. 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 Brazil. 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?

Muscle strength measured by dynamometer (time frame: 6 weeks). 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 13 Aug 2015; AzTrials last refreshed its copy on 30 Oct 2026.

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