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

September 9, 2022 updated by: Alejandro Paricio Rufino, University of Alcala

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
        • University of Alcalá

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BFR group
Training is applied to this group using low-load exercises with restriction of blood flow.
Other: BFR intervention

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.
Active Comparator: High load group
A program will be applied to this group of exercise with high loads as a method of treatment
Other: High load intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate structural changes in the tendon through the use of ultrasound
Time Frame: 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.
Baseline
To assest the echogenicity of each tendon by using software Fiji-Image J
Time Frame: 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.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline
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´´.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Néstro Ruíz Alberto, Physio, University of Alcalá

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Actual)

June 13, 2022

Study Completion (Anticipated)

September 10, 2022

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TFMAON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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