Healthy VolunteersNCT02918916
Phototherapy Applied During Combined Training
A study testing Phototherapy in people with Healthy Volunteers, run by São Paulo State University.
Trial summary
Introduction: Recent studies have shown positive results from the application of phototherapy for the improvement of performance and acceleration of the recovery process both in the application before and after exercise. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Phototherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2018
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (self-report);
- Male gender;
- Aged between 18-30 years;
- Agreement to participate through signed statement of informed consent
Who cannot join
- Presence of anemia, inflammation, or diabetes;
- History of metastasis.
- History of muscle injury in the lower limbs or spine in the previous six months;
- Occurrence of musculoskeletal injury during the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Phototherapy Applied During Combined Training on Performance and Post-exercise Recovery: Study Protocol of a Randomized Controlled Trial by Stratified Sample, Double-blind, Placebo-controlled
Introduction: Recent studies have shown positive results from the application of phototherapy for the improvement of performance and acceleration of the recovery process both in the application before and after exercise. However, the effects of phototherapy during combined training and after a primary adaptation process remain unclear.
Research objectives: The primary objective of the study is to analyze and compare the effects of phototherapy using different light sources (laser and light emmiting diode - LED) interacting with combined training on clinical, functional, and psychological outcomes and vascular endothelial growth factor. The secondary objective is to compare the benefits provided by phototherapy in participants with different levels of training adaptation.
Read more
Design: A controlled trial, double-blind, placebo-controlled will be conducted with stratified randomization and concealed allocation.
Participants and Setting: After fulfilling the eligibility criteria, forty-five male participants will participate in the study.
Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints and squats). In phase 2, participants will be allocated, through stratified randomization (based on adaptation capacity to training), into three groups: active phototherapy group (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training period will then start. In this phase the participants will carry out training normally with the adjusted loads and between sprints and squats will receive the recovery strategy related to the group to which they belong.
Intervention: Active and placebo phototherapy will be applied by a trained therapist, between sprints and squats. During the period of recovery strategies for the AG and PG, the CG participants will remain seated for passive recovery, supervised by an independent therapist.
Measurements: The measurements include clinical, functional, and psychological outcomes and vascular endothelial growth factor.
Read the detailed description
Introduction: Recent studies have shown positive results from the application of phototherapy for the improvement of performance and acceleration of the recovery process both in the application before and after exercise. However, the effects of phototherapy during combined training and after a primary adaptation process remain unclear.
Research objectives: The primary objective of the study is to analyze and compare the effects of phototherapy using different light sources (laser and LEDs) interacting with combined training on clinical, functional, and psychological outcomes and vascular endothelial growth factor. The secondary objective is to compare the benefits provided by phototherapy in participants with different levels of training adaptation.
Design: A controlled trial, double-blind, placebo-controlled will be conducted with stratified randomization and concealed allocation.
Participants and Setting: After fulfilling the eligibility criteria, forty-five male participants will participate in the study. The inclusion criteria include: healthy male, aged between 18-30 years who agree to participate in the study. Participants with the following will be excluded from the study: presence of anemia, inflammation, diabetes, history of metastasis or muscle injury in the lower limbs or spine in the previous six months, and occurrence of musculoskeletal injury during the study.
Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints and squats). In phase 2, participants will be allocated, through stratified randomization (based on adaptation capacity to training), into three groups: active phototherapy group (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training period will then start. In this phase the participants will carry out training normally with the adjusted loads and between sprints and squats will receive the recovery strategy related to the group to which they belong.
Intervention: Active and placebo phototherapy will be applied by a trained therapist, between sprints and squats, bilaterally to six sites of the quadriceps in direct contact with the skin. The dosage applied will be 30J per site. The same procedures as the AG will be applied to the PG, however the emitter will be disabled. During the period of recovery strategies for the AG and PG, the CG participants will remain seated for passive recovery, supervised by an independent therapist.
Measurements: The measurements include clinical (muscle soreness, pain threshold, perception of exertion, and perception of recovery), functional (squat strength and power, maximal voluntary isometric contraction, maximal incremental test, squat jump, and sprint test), and psychological (self-assessments of readiness for exercise, fatigue, vigor, pain, and belief of intervention effectiveness) outcomes and vascular endothelial growth factor.
Analysis: For analysis of functional outcomes, data normality will be checked by the Kolmogorov-Smirnov test with changes from baseline followed by the Student T test for comparisons. For other outcomes, sphericity of the data will be tested by the Mauchly's test. In case of violation of the sphericity assumption, Greenhouse-Geisser corrections will be used. Data will be analyzed using repeated-measures analysis of variance (Bonferroni's test will be performed when required), which provide information on time, group, and interaction effects. A significance level of 5% will be assumed for all statistical analysis.
- Conditions
- Healthy Volunteers
- Being tested
- Phototherapy, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyOther
Also called Low-level laser therapy, Light-emitting diode
The dosage applied will be 30 Joules per site (180 Joules per muscle). Parameters are described in the attached document.
PlaceboOther
The same procedures as in the active phototherapy group will be applied to the placebo phototherapy group; however the emitter will be disabled.
| Study group | Role | What they receive |
|---|---|---|
| Active phototherapy group | Experimental | Phototherapy will be applied between sprint and squat training (exactly 10 minutes before squat training).
Active phototherapy will be applied by a trained therapist using a MR4 LaserShower 50 4D emitter (Multi Radiance Medical, USA), bilaterally to six sites of the quadriceps (two centrally - rectus femoris and vastus intermedius; two laterally - vastus lateralis; two medially - vastus medially) in direct contact with the skin.
The optical power will be calibrated before irradiation in each participant using a Thorlabs thermal power meter (Model S322C, Thorlabs, Newton, New Jersey, USA). Receives: Other: Phototherapy |
| Placebo phototherapy group | Placebo comparator | Placebo will be applied between sprint and squat training (exactly 10 minutes before squat training). Placebo phototherapy will be applied by a trained therapist using a MR4 LaserShower 50 4D emitter (Multi Radiance Medical, USA), bilaterally to six sites of the quadriceps (two centrally - rectus femoris and vastus intermedius; two laterally - vastus lateralis; two medially - vastus medially) in direct contact with the skin. To receive active or placebo phototherapy the participant will be placed in the supine position.
The same procedures as in the active phototherapy group will be applied to the placebo phototherapy group; however the emitter will be disabled. Receives: Other: Placebo |
| Control group | No intervention | Passive recovery will be applied between sprint and squat training (exactly 10 minutes before squat training). During the period when the other groups are receiving recovery strategies, the control group participants will remain seated for passive recovery, supervised by an independent therapist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from 6-week Maximal voluntary isometric contraction at 12-week of training
Prior to the MVIC evaluation, participants will conduct a warm up consisting of 10 repetitions of knee flexion-extension at 180°.s-1 throughout the range of motion. The MIVC will be determined by the highest maximal isometric torque over three contractions of five seconds at 60° of knee flexion (with 0° corresponding to the maximum extension). The repetitions will be separated by a 2-minute rest interval. Participants will be instructed to perform maximal contractions and verbally encouraged by the researcher during the evaluation.
Measured: Change between 6-week and 12-week of training
Secondary outcomes (11)
Strength and power test
Strength and power tests will be carried out in vertical squat equipment with a guided bar.
Measured: Baseline, after 6-week, after 13-week of training
Maximum oxygen consumption (VO2max)
The maximum oxygen consumption (VO2max) will be determined on a treadmill using an incremental protocol.
Gas analysis will be measured continuously and the average value of every 30 seconds recorded (VO2000, MedGraphics, Minnesota, USA).
Measured: Baseline, after 6-week, after 13-week of training
Squat jump
To perform the squat jump test, the participant will remain with the sole of their feet in contact with the jump platform (Multisprint, Hidrofit, Brazil), legs at 90° of flexion, hands on hips, trunk upright and without previous movements. The participant will perform a jump keeping their legs straight (180°) and touch the platform again.
Each participant will perform three complete tests with a rest interval of 30 seconds between each repetition. The best measure of the tests will be adopted.
Measured: Baseline, after 6-week, after 13-week of training
Sprint test
To perform the sprint test, participants will perform three maximum sprints exceeding 30 meters with rest intervals of 3-minutes. Performance times at 10, 20 and 30 meters will be recorded by photocells (Multisprint, Hidrofit, Brazil). The average of the two best tests will be adopted. Participants will be encouraged verbally during the test.
Measured: Baseline, after 6-week, after 13-week of training
Muscle soreness
Values of muscle soreness will be obtained through a visual analog scale (VAS), with 10-points, with 'zero' corresponding to absence of soreness and '10' to the maximum level supported by the participant, as described previously. Participants will be asked about the presence of soreness in the lower limbs.
Measured: Baseline, 5-week, after 6-week, 12-week, after 13-week of training
Pain threshold
To assess the pain threshold, pressure algometry will be applied at five specific sites of the quadriceps. The participant will be placed in the supine position and the markers will be carried out in the dominant leg. The sites will be located using the reference system, which primarily identifies two anatomic points: anterior superior iliac spine (ASIS) and upper pole of the patella (UPP). Thus, the sites assessed will be: 15 cm distal to the ASIS, 4 cm proximal to the UPP, mean point between the ASIS and UPP, and 2 cm lateral and medial to the mean point.
Pain threshold will be defined in Kgf through the minimal pressure required to induce a pain sensation or discomfort. Participants will be instructed to signal when the pressure sensation becomes discomfort. The pressure will not exceed 2.55 Kgf.
Measured: Baseline, 5-week, after 6-week, 12-week, after 13-week of training
Perception of exertion
The level of exertion reported by participants will be assessed using the Borg Scale (6-20 points), with 'six' corresponding to 'very easy' and '20' to 'exhaustive'. Participants will be asked about their perception of exertion in the upper and lower limbs.
Measured: 5-week, 12-week of training
Perception of recovery
Perception of recovery will be assessed by a 10-point Likert Scale, with 'one' corresponding to 'not recovered' and '10' to 'fully recovery'.
Measured: 5-week, 12-week of training
Psychological questionnaire
Participants will complete a psychological questionnaire that aims to document, subjectively, the readiness for exercise, fatigue, vigor, sleepiness, and pain. Participants will be instructed to mark an "X" on a 10-cm visual analog scale between two extremes, with 'zero' corresponding to 'least possible' and '10' 'most possible' for each rating.
Measured: Baseline, before 5-week, before 12-week of training
Belief questionnaire
After phase 1, participants will answer a belief questionnaire to measure their 'belief' in the effectiveness of the technique. Participants will be instructed to mark an "X" on a 5-point Likert Scale, with 'zero' corresponding to 'not effective' and 'ten' to 'extremely effective'.
After application of the recovery techniques, the participants will complete a similar questionnaire to measure their perceived effectiveness of the technique.
Measured: After 6-week, after 13-week of training
Vascular endothelial growth factor
To analyze the vascular endothelial growth factor (VEGF) 10 ml of blood will be collected. Plasma from this sample will be stored at -80°C for later analysis. The plasma level of VEGF will be analyzed using the ELISA method in duplicate (enzyme-linked immunosorbent assays) following the manufacturer's instructions (RayBio, Norcross, GA, USA).
Measured: Baseline, after 6-week, after 13-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Carlos Pastre, PhD, Principal investigator, Univ Estadual Paulista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918916
- Sponsor's protocol ID
- 2015/25219-0
- Other IDs
- 2015
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phototherapy Applied During Combined Training on Performance and Post-exercise Recovery: Study Protocol of a Randomized Controlled Trial by Stratified Sample, Double-blind, Placebo-controlled
- ClinicalTrials.gov ID
- NCT02918916
- Acronym / sponsor ID
- 2015/25219-0
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2017
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- 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.
Introduction: Recent studies have shown positive results from the application of phototherapy for the improvement of performance and acceleration of the recovery process both in the application before and after exercise. However, the effects of phototherapy during combined training and after a primary adaptation process remain unclear.
Research objectives: The primary objective of the study is to analyze and compare the effects of phototherapy using different light sources (laser and light emmiting diode - LED) interacting with combined training on clinical, functional, and psychological outcomes and vascular endothelial growth factor. The secondary objective is to compare the benefits provided by phototherapy in participants with different levels of training adaptation.
Design: A controlled trial, double-blind, placebo-controlled will be conducted with stratified randomization and concealed allocation.
Participants and Setting: After fulfilling the eligibility criteria, forty-five male participants will participate in the study.
Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints and squats). In phase 2, participants will be allocated, through stratified randomization (based on adaptation capacity to training), into three groups: active phototherapy group (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training period will then start. In this phase the participants will carry out training normally with the adjusted loads and between sprints and squats will receive the recovery strategy related to the group to which they belong.
Intervention: Active and placebo phototherapy will be applied by a trained therapist, between sprints and squats. During the period of recovery strategies for the AG and PG, the CG participants will remain seated for passive recovery, supervised by an independent therapist.
Measurements: The measurements include clinical, functional, and psychological outcomes and vascular endothelial growth factor.
Detailed description
Introduction: Recent studies have shown positive results from the application of phototherapy for the improvement of performance and acceleration of the recovery process both in the application before and after exercise. However, the effects of phototherapy during combined training and after a primary adaptation process remain unclear.
Research objectives: The primary objective of the study is to analyze and compare the effects of phototherapy using different light sources (laser and LEDs) interacting with combined training on clinical, functional, and psychological outcomes and vascular endothelial growth factor. The secondary objective is to compare the benefits provided by phototherapy in participants with different levels of training adaptation.
Design: A controlled trial, double-blind, placebo-controlled will be conducted with stratified randomization and concealed allocation.
Participants and Setting: After fulfilling the eligibility criteria, forty-five male participants will participate in the study. The inclusion criteria include: healthy male, aged between 18-30 years who agree to participate in the study. Participants with the following will be excluded from the study: presence of anemia, inflammation, diabetes, history of metastasis or muscle injury in the lower limbs or spine in the previous six months, and occurrence of musculoskeletal injury during the study.
Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints and squats). In phase 2, participants will be allocated, through stratified randomization (based on adaptation capacity to training), into three groups: active phototherapy group (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training period will then start. In this phase the participants will carry out training normally with the adjusted loads and between sprints and squats will receive the recovery strategy related to the group to which they belong.
Intervention: Active and placebo phototherapy will be applied by a trained therapist, between sprints and squats, bilaterally to six sites of the quadriceps in direct contact with the skin. The dosage applied will be 30J per site. The same procedures as the AG will be applied to the PG, however the emitter will be disabled. During the period of recovery strategies for the AG and PG, the CG participants will remain seated for passive recovery, supervised by an independent therapist.
Measurements: The measurements include clinical (muscle soreness, pain threshold, perception of exertion, and perception of recovery), functional (squat strength and power, maximal voluntary isometric contraction, maximal incremental test, squat jump, and sprint test), and psychological (self-assessments of readiness for exercise, fatigue, vigor, pain, and belief of intervention effectiveness) outcomes and vascular endothelial growth factor.
Analysis: For analysis of functional outcomes, data normality will be checked by the Kolmogorov-Smirnov test with changes from baseline followed by the Student T test for comparisons. For other outcomes, sphericity of the data will be tested by the Mauchly's test. In case of violation of the sphericity assumption, Greenhouse-Geisser corrections will be used. Data will be analyzed using repeated-measures analysis of variance (Bonferroni's test will be performed when required), which provide information on time, group, and interaction effects. A significance level of 5% will be assumed for all statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active phototherapy group | Experimental | Other: PhototherapyPhototherapy will be applied between sprint and squat training (exactly 10 minutes before squat training). Active phototherapy will be applied by a trained therapist using a MR4 LaserShower 50 4D emitter (Multi Radiance Medical, USA), bilaterally to six sites of the quadriceps (two centrally - rectus femoris and vastus intermedius; two laterally - vastus lateralis; two medially - vastus medially) in direct contact with the skin. The optical power will be calibrated before irradiation in each participant using a Thorlabs thermal power meter (Model S322C, Thorlabs, Newton, New Jersey, USA). |
| Placebo phototherapy group | Placebo comparator | Other: PlaceboPlacebo will be applied between sprint and squat training (exactly 10 minutes before squat training). Placebo phototherapy will be applied by a trained therapist using a MR4 LaserShower 50 4D emitter (Multi Radiance Medical, USA), bilaterally to six sites of the quadriceps (two centrally - rectus femoris and vastus intermedius; two laterally - vastus lateralis; two medially - vastus medially) in direct contact with the skin. To receive active or placebo phototherapy the participant will be placed in the supine position. The same procedures as in the active phototherapy group will be applied to the placebo phototherapy group; however the emitter will be disabled. |
| Control group | No intervention | –Passive recovery will be applied between sprint and squat training (exactly 10 minutes before squat training). During the period when the other groups are receiving recovery strategies, the control group participants will remain seated for passive recovery, supervised by an independent therapist. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy (self-report);
- Male gender;
- Aged between 18-30 years;
- Agreement to participate through signed statement of informed consent
Key exclusion criteria (4 listed)
- Presence of anemia, inflammation, or diabetes;
- History of metastasis.
- History of muscle injury in the lower limbs or spine in the previous six months;
- Occurrence of musculoskeletal injury during the study.
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 |
|---|---|---|
| PhototherapyAlso: Low-level laser therapy, Light-emitting diodeThe dosage applied will be 30 Joules per site (180 Joules per muscle). Parameters are described in the attached document. | Other | Active phototherapy group |
| PlaceboThe same procedures as in the active phototherapy group will be applied to the placebo phototherapy group; however the emitter will be disabled. | Other | Placebo phototherapy group |
Primary outcome
Change from 6-week Maximal voluntary isometric contraction at 12-week of training
Time frame: Change between 6-week and 12-week of training
Prior to the MVIC evaluation, participants will conduct a warm up consisting of 10 repetitions of knee flexion-extension at 180°.s-1 throughout the range of motion. The MIVC will be determined by the highest maximal isometric torque over three contractions of five seconds at 60° of knee flexion (with 0° corresponding to the maximum extension). The repetitions will be separated by a 2-minute rest interval. Participants will be instructed to perform maximal contractions and verbally encouraged by the researcher during the evaluation.
11 secondary outcomes
Strength and power test
Time frame: Baseline, after 6-week, after 13-week of training
Maximum oxygen consumption (VO2max)
Time frame: Baseline, after 6-week, after 13-week of training
Squat jump
Time frame: Baseline, after 6-week, after 13-week of training
Sprint test
Time frame: Baseline, after 6-week, after 13-week of training
Muscle soreness
Time frame: Baseline, 5-week, after 6-week, 12-week, after 13-week of training
Pain threshold
Time frame: Baseline, 5-week, after 6-week, 12-week, after 13-week of training
Perception of exertion
Time frame: 5-week, 12-week of training
Perception of recovery
Time frame: 5-week, 12-week of training
Psychological questionnaire
Time frame: Baseline, before 5-week, before 12-week of training
Belief questionnaire
Time frame: After 6-week, after 13-week of training
Vascular endothelial growth factor
Time frame: Baseline, after 6-week, after 13-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
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.
Carlos Pastre, PhD principal investigator
Univ Estadual Paulista
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy in people with Healthy Volunteers, run by São Paulo State University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Pastre, PhD (+551832295528, pastre@fct.unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from 6-week Maximal voluntary isometric contraction at 12-week of training (time frame: Change between 6-week and 12-week of training). 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 29 Sep 2016.