NCT05538494

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

August 26, 2022

Last Update Submit

September 9, 2022

Conditions

Keywords

Patellar tendonBFRTvascular occlusionUltrasoundblood flow restriction training

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

EXPERIMENTAL

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

Other: BFR intervention

High load group

ACTIVE COMPARATOR

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

Other: High load intervention

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.

BFR group

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.

High load group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Related Publications (25)

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    PMID: 14858310BACKGROUND
  • Heinemeier KM, Kjaer M. In vivo investigation of tendon responses to mechanical loading. J Musculoskelet Neuronal Interact. 2011 Jun;11(2):115-23.

    PMID: 21625048BACKGROUND
  • Onambele-Pearson GL, Pearson SJ. The magnitude and character of resistance-training-induced increase in tendon stiffness at old age is gender specific. Age (Dordr). 2012 Apr;34(2):427-38. doi: 10.1007/s11357-011-9248-y. Epub 2011 Apr 20.

    PMID: 21505764BACKGROUND
  • Docking SI, Cook J. How do tendons adapt? Going beyond tissue responses to understand positive adaptation and pathology development: A narrative review. J Musculoskelet Neuronal Interact. 2019 Sep 1;19(3):300-310.

    PMID: 31475937BACKGROUND
  • Magnusson SP, Narici MV, Maganaris CN, Kjaer M. Human tendon behaviour and adaptation, in vivo. J Physiol. 2008 Jan 1;586(1):71-81. doi: 10.1113/jphysiol.2007.139105. Epub 2007 Sep 13.

    PMID: 17855761BACKGROUND
  • Kubo K, Ikebukuro T, Yaeshima K, Yata H, Tsunoda N, Kanehisa H. Effects of static and dynamic training on the stiffness and blood volume of tendon in vivo. J Appl Physiol (1985). 2009 Feb;106(2):412-7. doi: 10.1152/japplphysiol.91381.2008. Epub 2008 Dec 26.

    PMID: 19112156BACKGROUND
  • Kubo K, Morimoto M, Komuro T, Yata H, Tsunoda N, Kanehisa H, Fukunaga T. Effects of plyometric and weight training on muscle-tendon complex and jump performance. Med Sci Sports Exerc. 2007 Oct;39(10):1801-10. doi: 10.1249/mss.0b013e31813e630a.

    PMID: 17909408BACKGROUND
  • Grigg NL, Wearing SC, Smeathers JE. Eccentric calf muscle exercise produces a greater acute reduction in Achilles tendon thickness than concentric exercise. Br J Sports Med. 2009 Apr;43(4):280-3. doi: 10.1136/bjsm.2008.053165. Epub 2008 Nov 19.

    PMID: 19019906BACKGROUND
  • Iwanuma S, Akagi R, Kurihara T, Ikegawa S, Kanehisa H, Fukunaga T, Kawakami Y. Longitudinal and transverse deformation of human Achilles tendon induced by isometric plantar flexion at different intensities. J Appl Physiol (1985). 2011 Jun;110(6):1615-21. doi: 10.1152/japplphysiol.00776.2010. Epub 2011 Mar 17.

    PMID: 21415176BACKGROUND
  • Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009 Jun;43(6):409-16. doi: 10.1136/bjsm.2008.051193. Epub 2008 Sep 23.

    PMID: 18812414BACKGROUND
  • Syha R, Springer F, Grozinger G, Wurslin C, Ipach I, Ketelsen D, Schabel C, Gebhard H, Hein T, Martirosian P, Schick F, Claussen CD, Grosse U. Short-term exercise-induced changes in hydration state of healthy Achilles tendons can be visualized by effects of off-resonant radiofrequency saturation in a three-dimensional ultrashort echo time MRI sequence applied at 3 Tesla. J Magn Reson Imaging. 2014 Dec;40(6):1400-7. doi: 10.1002/jmri.24488. Epub 2013 Nov 8.

    PMID: 24214925BACKGROUND
  • Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.

    PMID: 25430600BACKGROUND
  • Chulvi-Medrano I, Picon-Martinez M, Cortell-Tormo JM, Tortosa-Martinez J, Alonso-Aubin DA, Alakhdar Y. Different Time Course of Recovery in Achilles Tendon Thickness After Low-Load Resistance Training With and Without Blood Flow Restriction. J Sport Rehabil. 2020 Jul 27;30(2):300-305. doi: 10.1123/jsr.2019-0403.

    PMID: 32717720BACKGROUND
  • Hullfish TJ, Baxter JR. A Reliable Method for Quantification of Tendon Structure Using B-Mode Ultrasound. J Ultrasound Med. 2018 Oct;37(10):2419-2424. doi: 10.1002/jum.14592. Epub 2018 Mar 25.

    PMID: 29574900BACKGROUND
  • Cook JL, Khan KM, Harcourt PR, Kiss ZS, Fehrmann MW, Griffiths L, Wark JD. Patellar tendon ultrasonography in asymptomatic active athletes reveals hypoechoic regions: a study of 320 tendons. Victorian Institute of Sport Tendon Study Group. Clin J Sport Med. 1998 Apr;8(2):73-7. doi: 10.1097/00042752-199804000-00001.

    PMID: 9641432BACKGROUND
  • Rios-Diaz J, de Groot Ferrando A, Martinez-Paya JJ, del Bano Aledo ME. [Reliability and reproducibility of a morpho-textural image analysis method over a patellar ligament ultrasonography]. Reumatol Clin. 2010 Nov-Dec;6(6):278-84. doi: 10.1016/j.reuma.2010.01.008. Epub 2010 May 13. Spanish.

    PMID: 21794733BACKGROUND
  • Hansen P, Bojsen-Moller J, Aagaard P, Kjaer M, Magnusson SP. Mechanical properties of the human patellar tendon, in vivo. Clin Biomech (Bristol). 2006 Jan;21(1):54-8. doi: 10.1016/j.clinbiomech.2005.07.008. Epub 2005 Sep 23.

    PMID: 16183183BACKGROUND
  • Martínez Payá JJ, Ríos Díaz J, Baño Aledo, María Elena del. El análisis textural mediante las matrices de co-ocurrencia (GLCM) sobre la imagen ecográfica del tendón rotuliano es de utilidad para la detección de cambios histológicos tras un entrenamiento con plataforma de vibración. Cultura, ciencia y deporte 2009;4(11):91-102.

    BACKGROUND
  • Cobos-Carbo A, Augustovski F. [CONSORT 2010 Declaration: updated guideline for reporting parallel group randomised trials]. Med Clin (Barc). 2011 Jul 23;137(5):213-5. doi: 10.1016/j.medcli.2010.09.034. Epub 2011 Jan 15. No abstract available. Spanish.

    PMID: 21239025BACKGROUND
  • Abe T, Yasuda T, Midorikawa T, Sato Y, CF K, Inoue K, et al. Skeletal muscle size and circulating IGF-1 are increased after two weeks of twice daily "KAATSU" resistance training. International Journal of KAATSU Training Research 2005;1(1):6-12.

    BACKGROUND
  • Risch L, Mayer F, Cassel M. Doppler Flow Response Following Running Exercise Differs Between Healthy and Tendinopathic Achilles Tendons. Front Physiol. 2021 Mar 23;12:650507. doi: 10.3389/fphys.2021.650507. eCollection 2021.

    PMID: 33833692BACKGROUND
  • Balsalobre-Fernandez C, Marchante D, Munoz-Lopez M, Jimenez SL. Validity and reliability of a novel iPhone app for the measurement of barbell velocity and 1RM on the bench-press exercise. J Sports Sci. 2018 Jan;36(1):64-70. doi: 10.1080/02640414.2017.1280610. Epub 2017 Jan 18.

    PMID: 28097928BACKGROUND
  • Giles L, Webster KE, McClelland J, Cook JL. Quadriceps strengthening with and without blood flow restriction in the treatment of patellofemoral pain: a double-blind randomised trial. Br J Sports Med. 2017 Dec;51(23):1688-1694. doi: 10.1136/bjsports-2016-096329. Epub 2017 May 12.

    PMID: 28500081BACKGROUND
  • Moisés Picón Martínez. Efectos agudos del entrenamiento con restricción del flujo sanguíneo sobre el tendón, la respuesta cardiovascular y la respuesta muscular Universitat d'Alacant - Universidad de Alicante; 2018.

    BACKGROUND
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    PMID: 30246795BACKGROUND

Study Officials

  • Néstro Ruíz Alberto, Physio

    University of Alcala

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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

Locations