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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05597423
Other study ID # ECM_22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date February 28, 2023

Study information

Verified date July 2023
Source São Paulo State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Within the routine of resistance training, stimulus are implemented to meet predetermined goals for its practitioners. In order for there to be a balance in the imposed loads, a recovery period is necessary for supercompensation to occur. Recovery is a multifactorial process and to consider an individual recovered it is necessary to respect the integration of physiological, biomechanical and psychological factors, in addition, perceptual markers, which are not widely investigated in the literature, seem to be effective recovery markers. Massage is a technique that stands out for its wide use after physical exercise in order to help accelerate the recovery process. In the literature, studies that investigated the influence of massage on performance did not find positive results and some authors question the real need to apply the technique to aid recovery. However, in the perceptual parameters, massage seems to have a good influence, such as pain reduction, perception of fatigue and improvement in the perception of recovery. Thus, understanding the experience that massage can provide during a training period can be an important outcome along with variables already used. The hypothesis of this study is that massage will improve perceptual parameters over a training period and, consequently, will improve the experience between training sessions without positively or negatively interfering in performance.


Description:

A sample of 120 participants will be recruited for the study. This is a parallel randomized controlled clinical trial lasting 4 weeks, each week will consist of 5 resistance training sessions. Participants will be randomized into three groups, control, intervention or placebo. Interventions will take place after training focused on the lower limbs. The intervention group will receive a massage for 16 minutes, in the placebo group the massage cream will be applied and the participants will be asked to remain in the supine position for 16 minutes and the control group will wait the same time at rest. All participants will perform an initial assessment consisting of an initial screening questionnaire, referred morbidity index, jump test and strength test. At the beginning, during and at the end of each lower limb training, after the interventions over 96 hours, the perceptual parameters will be evaluated and the assessment of muscle tone and stiffness, elasticity, mechanical stress relaxation time and creep will be before and after the training and after the intervention. On the second day of the lower limb training on each week, the Squat Jump Test will be evaluated before, after training and after the intervention. At the end of the 4 weeks of training, the participant will perform evaluations of functional and strength outcomes. At the end of the study, the preference of the participant and the cost-benefit of the technique will also be evaluated. Participant satisfaction will be evaluated after the technique. At the end of each week and at the end of the study, a balance of outcomes will be carried out. At the end of the study, the participant will also answer a questionnaire about sensations during training to perform a qualitative analysis. Data will be described as mean and standard deviation or median and interquartile range depending on the data distribution. Data normality will be tested by the Shapiro-Wilk test. Comparisons between techniques and associations will be performed using generalized mixed models with post Bonferroni test. All analyzes will assume a significance level of p>0.05.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - age between 18 to 35 years; - practice resistance training for at least 2 months; - train at least 5 times a week; - not having suffered an injury in the last 6 months in the lower limbs; - not being a smoker. Exclusion Criteria: - use anti-inflammatory and/or analgesic medication during the study period; - present an inflammatory process during the study period; - not reaching 80% frequency in lower limb training during the study period.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Massage
The massage will be applied for 16 minutes on the quadriceps, calf, hamstrings and lower back bilaterally with 4 different pressures.
Placebo
The cream will be applied to the quadriceps, calf, hamstring and lower back bilaterally and the participant will wait 16 minutes lying down in the supine position.

Locations

Country Name City State
Brazil Sao Paulo State University Presidente Prudente São Paulo

Sponsors (1)

Lead Sponsor Collaborator
São Paulo State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceptual parameters Post-Exercise Perception Questionnaire (topic before training). The questionnaire will assess the following perceptual parameters: well-being, physically prepared for training, mentally prepared for training, perception of mental fatigue, lower limb fatigue, lower limb muscle pain, sensation of lower limb muscle tension, lower limb muscle discomfort and perception of recovery. All parameters will be evaluated by a 5-point Likert scale (1=nothing; 2= a little; 3=moderate; 4=a lot; 5=extremely) Up to 4 weeks before all lower limb training
Primary Perceptual parameters Post-Exercise Perception Questionnaire (topic during training). The questionnaire will assess the following perceptual parameters: lower limb fatigue, lower limb muscle pain, sensation of lower limb muscle tension and lower limb muscle discomfort. All parameters will be evaluated by a 5-point Likert scale (1=nothing; 2= a little; 3=moderate; 4=a lot; 5=extremely) Up to 4 weeks during all lower limb training
Primary Perceptual parameters Post-Exercise Perception Questionnaire (topic after training). The questionnaire will assess the following perceptual parameters: well-being, perception of mental fatigue, lower limb fatigue, lower limb muscle pain, sensation of lower limb muscle tension, lower limb muscle discomfort and perception of recovery. All parameters will be evaluated by a 5-point Likert scale (1=nothing; 2= a little; 3=moderate; 4=a lot; 5=extremely) Up to 4 weeks after all lower limb training
Primary Perceptual parameters Post-Exercise Perception Questionnaire (topic after training). The questionnaire will assess the following perceptual parameters: well-being, perception of mental fatigue, lower limb fatigue, lower limb muscle pain, sensation of lower limb muscle tension, lower limb muscle discomfort and perception of recovery. All parameters will be evaluated by a 5-point Likert scale (1=nothing; 2= a little; 3=moderate; 4=a lot; 5=extremely) Up to 4 weeks after the application of intervention in all lower limb training
Primary Perceptual parameters Post-Exercise Perception Questionnaire (topic between trainings). The questionnaire will assess the following perceptual parameters: well-being, lower limb fatigue, lower limb muscle pain, sensation of lower limb muscle tension, lower limb muscle discomfort and perception of recovery. All parameters will be evaluated by a 5-point Likert scale (1=nothing; 2= a little; 3=moderate; 4=a lot; 5=extremely) 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1, 2, 4, 8, 12, 16, 20, 24, 48, 72 and 96 hours after the application of intervention in all lower limb training up to 4 weeks
Secondary Inferior limb power Inferior limb power will be measured by the squat jump test (cm) Change from baseline to 4 weeks
Secondary Inferior limb power Inferior limb power will be measured by the squat jump test (cm) Up to 4 weeks change from baseline to after lower limb training
Secondary Inferior limb power Inferior limb power will be measured by the squat jump test (cm) Up to 4 weeks change from baseline to after the application of intervention in lower limb training
Secondary Lower limb strength Lower limb strength will be measured by the one-repetition maximum test Change from baseline to 4 weeks
Secondary Muscle tone Muscle tone will be measured in hertz by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally. Up to 4 weeks change from baseline to after all lower limb training
Secondary Muscle tone Muscle tone will be measured in hertz by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally. Up to 4 weeks change from baseline to after the application of intervention in all lower limb training
Secondary Muscle stiffness Muscle stiffness will be measured in newton meter by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally. Up to 4 weeks change from baseline to after all lower limb training
Secondary Muscle stiffness Muscle stiffness will be measured in newton meter by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally. Up to 4 weeks change from baseline to after the application of intervention in all lower limb training
Secondary Elasticity Elasticity will be measured in logarithmic decrement of natural oscillation (logD) by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally Up to 4 weeks change from baseline to after all lower limb training
Secondary Elasticity Elasticity will be measured in logarithmic decrement of natural oscillation (logD) by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally Up to 4 weeks change from baseline to after the application of intervention in all lower limb training
Secondary Mechanical stress relaxation time Mechanical stress relaxation time will be measured in milliseconds by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally. Up to 4 weeks change from baseline to after all lower limb training
Secondary Mechanical stress relaxation time Mechanical stress relaxation time will be measured in milliseconds by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally. Up to 4 weeks change from baseline to after the application of intervention in all lower limb training
Secondary Creep Creep (relationship between relaxation time and muscle deformation time) will be measured by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally. Up to 4 weeks change from baseline to after all lower limb training
Secondary Creep Creep (relationship between relaxation time and muscle deformation time) will be measured by the MyotonPRO device wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the quadriceps, hamstrings, lumbar multifidus and soleus bilaterally Up to 4 weeks change from baseline to after the application of intervention in all lower limb training
Secondary Technical preference The participant will be asked about the preference of the technique included in the training routine (yes or no) Week 4
Secondary Technique belief Participants will answer how they believe the technique is cost-effective using a 5 point likert scale (1=poor, 2=bad, 3=indifferent, 4=good, 5=excellent) Week 4
Secondary Participant satisfaction about the technique assessed by a 5-point Likert scale [followed by its scale information in the Description] The participant will be asked about satisfaction of the technique received using a 5 point likert scale (1=completely dissatisfied, 2=dissatisfied, 3=neither satisfied nor dissatisfied, 4=satisfied, 5=completely satisfied) Up to 4 weeks immediately after intervention
Secondary Participant's perception of the training Participants will be asked to answer the open questions for a qualitative analysis: "What positive and/or negative feelings do you have after an lower limb training? Describe how they appear or develop over time, including your activities of daily living.", " Considering the recovery strategy used for you after your lower limb training, talk about: how do you feel during this moment? What do you believe that what is done during this period gives you in relation to recovery? Your preference regarding what to do immediately after training." and "Are there any sensations related to the training you perform that you would like to eliminate? What would they be and would you invest time and/or money to eliminate them?" Week 4
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