Patellar TendinitisNCT05538494
Effects on the Patellar Tendon After Low-load Blood Flow Restriction Training.
A study testing BFR intervention and High load intervention in people with Patellar Tendinitis, run by University of Alcala at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellar Tendinitis
- What is being tested?
- BFR intervention and High load intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2021to 10 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patellar Tendinitis
- Being tested
- BFR intervention, High load intervention
- Keywords
- Patellar tendon, BFRT, vascular occlusion, Ultrasound, blood flow restriction training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR interventionOther
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.
High load interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BFR group | Experimental | Training is applied to this group using low-load exercises with restriction of blood flow. Receives: 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 Receives: Other: High load intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start20 Feb 2021
- Primary completion13 Jun 2022
- Study completion10 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Paricio Rufino, University of Alcala
- Investigators
- Néstro Ruíz Alberto, Physio, Principal investigator, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538494
- Sponsor's protocol ID
- TFMAON
- Status last verified
- Sep 2022
- First submitted
- 26 Aug 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
NEUBERGER A, PERRONE JC, SLACK HG. The relative metabolic inertia of tendon collagen in the rat. Biochem J. 1951 Jul;49(2):199-204. No abstract available.
PubMed 14858310Heinemeier KM, Kjaer M. In vivo investigation of tendon responses to mechanical loading. J Musculoskelet Neuronal Interact. 2011 Jun;11(2):115-23.
PubMed 21625048Onambele-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.
PubMed 21505764Docking 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.
PubMed 31475937Magnusson 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.
PubMed 17855761Kubo 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.
PubMed 19112156Kubo 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.
PubMed 17909408Grigg 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.
PubMed 19019906Iwanuma 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.
PubMed 21415176Cook 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.
PubMed 18812414Syha 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.
PubMed 24214925Scott 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.
PubMed 25430600Chulvi-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.
PubMed 32717720Hullfish 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.
PubMed 29574900Cook 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.
PubMed 9641432
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects on the Patellar Tendon After Low-load Blood-flow Restriction Training Versus High-load Conventional Training. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05538494
- Acronym / sponsor ID
- TFMAON
- Conditions
- Patellar Tendinitis
- Keywords
- Patellar tendon, BFRT, vascular occlusion, Ultrasound, blood flow restriction training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 10 Sep 2022 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BFR group | Experimental | Other: BFR interventionTraining is applied to this group using low-load exercises with restriction of blood flow. |
| High load group | Active comparator | Other: High load interventionA program will be applied to this group of exercise with high loads as a method of treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFR interventionTraining 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. | Other | BFR group |
| High load interventionA 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. | Other | High load group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 14858310NEUBERGER A, PERRONE JC, SLACK HG. The relative metabolic inertia of tendon collagen in the rat. Biochem J. 1951 Jul;49(2):199-204. No abstract available.
- Background: PubMed 21625048Heinemeier KM, Kjaer M. In vivo investigation of tendon responses to mechanical loading. J Musculoskelet Neuronal Interact. 2011 Jun;11(2):115-23.
- Background: PubMed 21505764Onambele-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.
- Background: PubMed 31475937Docking 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.
- Background: PubMed 17855761Magnusson 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.
- Background: PubMed 19112156Kubo 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.
- Background: PubMed 17909408Kubo 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.
- Background: PubMed 19019906Grigg 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.
- Background: PubMed 21415176Iwanuma 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.
- Background: PubMed 18812414Cook 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.
- Background: PubMed 24214925Syha 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.
- Background: PubMed 25430600Scott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Néstro Ruíz Alberto, Physio principal investigator
University of Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR intervention and High load intervention in people with Patellar Tendinitis, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate structural changes in the tendon through the use of ultrasound (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538494, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.