Effects on the Patellar Tendon After Low-load Blood Flow Restriction Training.
Short-term Effects on the Patellar Tendon After Low-load Blood-flow Restriction Training Versus High-load Conventional Training. Randomized Clinical Trial.
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2022
CompletedFirst Submitted
Initial submission to the registry
August 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2022
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedSeptember 14, 2022
September 1, 2022
1.3 years
August 26, 2022
September 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline
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.
Baseline
Other Outcomes (1)
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.
Baseline
Study Arms (2)
BFR group
EXPERIMENTALTraining is applied to this group using low-load exercises with restriction of blood flow.
High load group
ACTIVE COMPARATORA program will be applied to this group of exercise with high loads as a method of treatment
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alcala
Alcalá de Henares, Madrid, 28805, Spain
Related Publications (25)
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PMID: 30246795BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Néstro Ruíz Alberto, Physio
University of Alcala
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- double blinding between investigator and study participants
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
August 26, 2022
First Posted
September 14, 2022
Study Start
February 20, 2021
Primary Completion
June 13, 2022
Study Completion
September 10, 2022
Last Updated
September 14, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share