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临床试验/NCT05538494
NCT05538494进行中(未招募)不适用

Short-term Effects on the Patellar Tendon After Low-load Blood-flow Restriction Training Versus High-load Conventional Training. Randomized Clinical Trial.

University of Alcala2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
84
试验地点
2
主要终点
To evaluate structural changes in the tendon through the use of ultrasound

研究概览

简要总结

The main objective of this research project is to study the transient adaptations that occur in the tendon immediately after the object of training with low loads and blood flow restriction and to compare these adaptations with those derived from training with high loads, in order to thus helping to elucidate the complex existing framework regarding the effects of this training methodology on the tendon.

详细描述

Introduction

Nowadays, it is known that mechanical loading is essential to achieve tendon adaptations. So,if tendons are stimulated in the right way, positive changes will take part on the tendinous tissues increasing its capability to stand mechanical loading.In the last decade, low load blood flow restriction training has developed as an alternative methodto high load training, as some investigations have found a similar increase in force and hypertrophy between both training methods. Although, the evidence about tendon adaptations leading from low load blood flow restriction training is still very limited.Aim: The present study aims to study tendon temporary responses leading immediately after a low load blood flow restriction training and compare those adaptations with those leading from high load strength training.Design: A randomized case-control clinical trial will be conducted.Sample: The measurement of the sample size was done with theG*Power 3.1.5 program and was based on the time-by-group interaction of a mixed variance analysis (ANOVA). With two groups and three measurement moments. The final sample size was constituted by 84 subjectsMethods:The 84 participants will be randomly allocated in two groups: a) Low load blood flow restriction training (n=42); b) high load strength training (n=42). The low load blood flow restriction training group will perform a strength training with an intensity equivalent to 30% 1RM with an occlusion pressure of 80% on the total restriction pressure assessed individually, whilst the other group will train with a load equivalent of 80% 1RM. Patellar tendon characteristics will be studied as morphometry and densitometry parameters and microcirculation pre, post immediate intervention and 24 hourspost intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

double blinding between investigator and study participants

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Physically active population (physical activity between 1 and 3 weekly sessions). With the final purpose to adjust the results to normality and refer to a general population.
  • Subjects who have received the information sheet and have given their consent informed to participate in the study.

排除标准

  • People who reproduce pain or symptomatology to the execution of the exercise of the treatment.
  • People who have had symptoms in the last 2 months in the region below patellar
  • Present musculoskeletal injuries or inability to perform the protocol experimental.
  • Individuals with a training frequency equal to or greater than 5 sessions per week or that present a RM equal to or greater than 110kg. Since they do not fit a population and may affect the homogeneity of the sample.

结局指标

主要结局

To evaluate structural changes in the tendon through the use of ultrasound

时间窗: Baseline

Ultrasound will be used in order to collect the data of the images of each participants. Then, we will asses and compare possible changes in thickness, measured in cm, of each tendon before, after and 24 hour after the intervention.

To assest the echogenicity of each tendon by using software Fiji-Image J

时间窗: Baseline

A delimited area of 159x20 pixels inside the tendon structure will be selected. Then the program may classified all the pixels of each area on a gray scale of 255, resulting in an histogram of each tendon before, after and 24 hour after the intervention, measured in pixels in the gray scale.

次要结局

未报告次要终点

研究者

发起方
University of Alcala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Paricio Rufino

Physiotherapist

University of Alcala

研究点 (2)

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