Effects on the Patellar Tendon After Low-load Blood Flow Restriction Training.

Not Applicable

Active, not recruiting

• Conditions: Patellar Tendinitis
• Interventions: Other: BFR intervention; Other: High load intervention

• Registration Number: NCT05538494
• Lead Sponsor: University of Alcala

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.

Study Timeline

• Study Start: 2021-02-20
• Primary Completion: 2022-06-13
• Study First Submitted: 2022-08-26
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study Completion: 2022-09-10
• Study First Posted: 2022-09-14
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BFR group	BFR intervention	Training is applied to this group using low-load exercises with restriction of blood flow.
High load group	High load intervention	A program will be applied to this group of exercise with high loads as a method of treatment

Primary Outcome Measures

Name	Time	Method
To evaluate structural changes in the tendon through the use of ultrasound	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	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.

Trial Locations

Locations (1)

University of Alcala; 🇪🇸 Alcalá De Henares, Madrid, Spain