Clinical trial NCT05538494: Effects on the Patellar Tendon After Low-load Blood Flow Restriction Training.
Official title: Short-term Effects on the Patellar Tendon After Low-load Blood-flow Restriction Training Versus High-load Conventional Training. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellar Tendinitis
Keywords: Patellar tendon
BFRT
vascular occlusion
Ultrasound
blood flow restriction training
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group, which we will call the "BFR group", will be trained using low-load exercises with blood flow restriction. To the second group, which we will call "high load group", an exercise program with high loads will be applied.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To evaluate structural changes in the tendon through the use of ultrasound
timeFrame: Baseline
measure: To assest the echogenicity of each tendon by using software Fiji-Image J
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Evaluate the possible presence of micro vascularization of the patellar tendon through the visualization of the tendon structure with the doppler system of the ultrasound.
timeFrame: Baseline
Locations:
city: Alcalá De Henares
country: Spain
facility: University of Alcala
state: Madrid
Study officials:
affiliation: University of Alcala
name: Néstro Ruíz Alberto, Physio
role: PRINCIPAL_INVESTIGATOR
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