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

Primary Purpose

Patellar Tendinitis

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
BFR intervention
High load intervention
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinitis focused on measuring Patellar tendon, BFRT, vascular occlusion, Ultrasound, blood flow restriction training

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alcala

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BFR group

High load group

Arm Description

Training is applied to this group using low-load exercises with restriction of blood flow.

A program will be applied to this group of exercise with high loads as a method of treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 26, 2022
Last Updated
September 9, 2022
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT05538494
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
September 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinitis
Keywords
Patellar tendon, BFRT, vascular occlusion, Ultrasound, blood flow restriction training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
double blinding between investigator and study participants
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BFR group
Arm Type
Experimental
Arm Description
Training is applied to this group using low-load exercises with restriction of blood flow.
Arm Title
High load group
Arm Type
Active Comparator
Arm Description
A program will be applied to this group of exercise with high loads as a method of treatment
Intervention Type
Other
Intervention Name(s)
BFR intervention
Intervention Description
Training is applied to this group using low-load exercises with restriction of blood flow. Based on the variables used by the major part of the protocols used in studies on the ERFS, the protocol that will be applied to this group will consist of the following parameters. Training: 1 series of 30 repetitions followed by 3 series of 15 repetitions of squats Rest between series: Duration of 45 seconds. Workload: 30% of 1RM. Cadence: 2 seconds for the concentric phase and 2 seconds for the eccentric phase (2:2). Cuff pressure: The inflation pressure will be individualized for each individual. A pressure equivalent to 80% of the minimum pressure necessary for the total occlusion of the femoral artery. • Cuff placement: proximal quadriceps.
Intervention Type
Other
Intervention Name(s)
High load intervention
Intervention Description
A program will be applied to this group of exercise with high loads as a method of treatment in which the following will be applied parameters: Training: 4 series of 12 repetitions of squats. Rest between series: Duration 2 minutes. Workload: 70% of 1RM.
Primary Outcome Measure Information:
Title
To evaluate structural changes in the tendon through the use of ultrasound
Description
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.
Time Frame
Baseline
Title
To assest the echogenicity of each tendon by using software Fiji-Image J
Description
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.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
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.
Description
The Doppler mode of ultrasound will be used to observe and compare the presence of micro-vascularization inside the patellar tendon structure, before, immediately after and 24 hours after performing the intervention for each subject. The images where the doppler mode could detect some micro-vascularization may be assigned with ''Yes´´ and those which does not show any evidence of micro-vascularization ,may be assigned as ''no´´.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Néstro Ruíz Alberto, Physio
Organizational Affiliation
University of Alcala
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alcala
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects on the Patellar Tendon After Low-load Blood Flow Restriction Training.

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