NCT06485063

Brief Summary

This is a two-group randomized clinical trial (includes an experimental and a placebo group) to verify the effects of the Myofascial Reorganization (RMF) compared to the placebo-RMF technique on running performance and thermographic, biomechanical, and viscoelastic proprieties of lower limbs of male triathletes. Data collection will be carried out one week before the first intervention session, and one week after the last intervention session. Anthropometric characteristics (height and weight), lower limbs, and biomechanical, viscoelastic, and thermographic properties will be collected before any exercise tests. After this, the athlete will be submitted to: a 10-minute protocol to verify running economy on the treadmill, followed by an incremental test on the treadmill, and a time to exhaustion test. Evaluation procedures will carried out one week before (0 weeks) and one week after (7th week) the experimental/placebo intervention. Intervention sessions will occur during six weeks, twice a week, each session lasting up to 30 minutes.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 10, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

athletesperformancehealthyfascia

Outcome Measures

Primary Outcomes (4)

  • Running Economy

    the volume consumption of oxygen (VO2) required at a common velocity under the first lactate threshold in milliliters per minute per kilogram (mL.min-1.Kg-1).

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

  • Maximal volume consumption of oxygen

    The maximal volume consumption of oxygen (VO2max) in milliliters per minute per kilogram (mL.min-1.Kg-1) will be determined as the highest value reached in the last stage plotted employing means of 15 seconds.

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

  • Time to Exhaustion

    Time to volitional exhaustion during the Time to Exhaustion Test, running at 100% of the last velocity reached in the incremental test, in minutes and seconds.

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

  • Maximal velocity

    maximal velocity derived from the incremental graded test

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

Secondary Outcomes (7)

  • State of tension: F - Frequency or TONE

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

  • Dynamic Stiffness (N/m);

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

  • D -logarithmic decrement

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

  • R- Relaxation time

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

  • C - Creep

    Pre-intervention (0 week time point) and post-intervention (7 week time point)

  • +2 more secondary outcomes

Study Arms (2)

Myofascial Reorganization Group

EXPERIMENTAL

Each participant will receive 12 sessions of Myofascial Reorganization

Other: Myofascial Reorganization

Placebo Myofascial Reorganization

PLACEBO COMPARATOR

Each participant will receive 12 sessions of Myofascial Reorganization Placebo

Other: PLACEBO Myofascial Reorganization

Interventions

It is a manual technique in which the therapist applies a manual sustained oblique load of 45° with subsequent shear load. In general, the technique is divided into two stages, the first when the oblique load is accompanied by a passive shear load (applied by the therapist) during 1minute, and the second stage, when the shear oblique manual load is maintained but the shear load provoked by the participants' active movement (active shear load) during 1minute.

Also known as: RMF, Reorganização Miofascial
Myofascial Reorganization Group

it is light touch to the skin applied by the therapist, without provoking compression, or any constant or shear load during the fist minute. In the second minute, the participant adds active movements to the light touch. This two stage (each one during 1minute) is constructed to mimic the passive and the active stages of the real myofascial reorganization technique.

Also known as: RMF-PLACEBO, Reorganização Miofascial Placebo
Placebo Myofascial Reorganization

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes
  • Age between 18 and 45 years
  • years of competitive experience
  • Non-smokers
  • Training at least 3 times/week intending to compete in at least local competitions
  • No presenting lower limb surgery in the last 12 months
  • Not presenting lower limb injury in the last 6 months
  • Not presenting cerebellar diseases that limit sportive practice
  • Not presenting brain diseases that limit sportive practice
  • Not presenting musculoskeletal diseases that limit sportive practice
  • Not presenting signs of rhabdomyolysis
  • Not presenting systemic conditions that limit sportive practice
  • Not presenting metabolic that limits sports practice
  • Not presenting autoimmune conditions;
  • Not presenting cardiac conditions.

You may not qualify if:

  • Not accomplishing 83,3% (10 of 12 sessions) of the proposed experimental/placebo protocol
  • Not presenting themselves on the re-test day
  • Developing a lower limb musculoskeletal injury during the study's ongoing period.
  • Developing a back injury during the study's ongoing period?
  • Developing central or peripheral nervous system conditions during the study's ongoing period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health and Sport Sciences of the State University of Santa Catarina

Florianópolis, Santa Catarina, 88080350, Brazil

RECRUITING

Related Publications (47)

  • Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.

    PMID: 28630973BACKGROUND
  • Okano, A. H. et al. Comparação entre limiar anaeróbio determinado por variáveis ventilatórias e pela resposta do lactato sanguíneo em ciclistas. Rev. Bras. Med. do Esporte 12, 39-44 (2006).

    BACKGROUND
  • Borszcz, F. K. Reprodutibilidade e validade do functional threshold power em ciclistas. (Universidade do Estado de Santa Catarina, 2018).

    BACKGROUND
  • McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29.

    PMID: 34965513BACKGROUND
  • Moran RN, Hauth JM, Rabena R. The effect of massage on acceleration and sprint performance in track & field athletes. Complement Ther Clin Pract. 2018 Feb;30:1-5. doi: 10.1016/j.ctcp.2017.10.010. Epub 2017 Oct 28.

    PMID: 29389467BACKGROUND
  • Healey KC, Hatfield DL, Blanpied P, Dorfman LR, Riebe D. The effects of myofascial release with foam rolling on performance. J Strength Cond Res. 2014 Jan;28(1):61-8. doi: 10.1519/JSC.0b013e3182956569.

    PMID: 23588488BACKGROUND
  • Fletcher IM. The effects of precompetition massage on the kinematic parameters of 20-m sprint performance. J Strength Cond Res. 2010 May;24(5):1179-83. doi: 10.1519/JSC.0b013e3181ceec0f.

    PMID: 20386129BACKGROUND
  • Dibai-Filho AV, Guirro EC, Ferreira VT, Brandino HE, Vaz MM, Guirro RR. Reliability of different methodologies of infrared image analysis of myofascial trigger points in the upper trapezius muscle. Braz J Phys Ther. 2015 Mar-Apr;19(2):122-8. doi: 10.1590/bjpt-rbf.2014.0076. Epub 2015 Apr 27.

    PMID: 25993626BACKGROUND
  • Inglis EC, Iannetta D, Passfield L, Murias JM. Maximal Lactate Steady State Versus the 20-Minute Functional Threshold Power Test in Well-Trained Individuals: "Watts" the Big Deal? Int J Sports Physiol Perform. 2019 Nov 4;15(4):541-547. doi: 10.1123/ijspp.2019-0214. Print 2020 Apr 1.

    PMID: 31689684BACKGROUND
  • Borszcz FK, Tramontin AF, Bossi AH, Carminatti LJ, Costa VP. Functional Threshold Power in Cyclists: Validity of the Concept and Physiological Responses. Int J Sports Med. 2018 Oct;39(10):737-742. doi: 10.1055/s-0044-101546. Epub 2018 May 25.

    PMID: 29801189BACKGROUND
  • Corte AC, Pedrinelli A, Marttos A, Souza IFG, Grava J, Jose Hernandez A. Infrared thermography study as a complementary method of screening and prevention of muscle injuries: pilot study. BMJ Open Sport Exerc Med. 2019 Jan 3;5(1):e000431. doi: 10.1136/bmjsem-2018-000431. eCollection 2019.

    PMID: 30687515BACKGROUND
  • Bravo-Sanchez A, Abian P, Sanchez-Infante J, Esteban-Gacia P, Jimenez F, Abian-Vicen J. Objective Assessment of Regional Stiffness in Vastus Lateralis with Different Measurement Methods: A Reliability Study. Sensors (Basel). 2021 May 6;21(9):3213. doi: 10.3390/s21093213.

    PMID: 34066343BACKGROUND
  • Alaca N, Kablan N. Acute effects of cold spray application on mechanical properties of the rectus femoris muscle in athletes. J Bodyw Mov Ther. 2022 Apr;30:100-104. doi: 10.1016/j.jbmt.2022.02.010. Epub 2022 Feb 7.

    PMID: 35500956BACKGROUND
  • Frohlich-Zwahlen AK, Casartelli NC, Item-Glatthorn JF, Maffiuletti NA. Validity of resting myotonometric assessment of lower extremity muscles in chronic stroke patients with limited hypertonia: a preliminary study. J Electromyogr Kinesiol. 2014 Oct;24(5):762-9. doi: 10.1016/j.jelekin.2014.06.007. Epub 2014 Jun 24.

    PMID: 25023163BACKGROUND
  • Schoenrock B, Zander V, Dern S, Limper U, Mulder E, Veraksits A, Viir R, Kramer A, Stokes MJ, Salanova M, Peipsi A, Blottner D. Bed Rest, Exercise Countermeasure and Reconditioning Effects on the Human Resting Muscle Tone System. Front Physiol. 2018 Jul 3;9:810. doi: 10.3389/fphys.2018.00810. eCollection 2018.

    PMID: 30018567BACKGROUND
  • Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.

    PMID: 11018445BACKGROUND
  • Konrad, A. & Paternoster, F. K. No Association between Jump Parameters and Tissue Stiffness in the Quadriceps and Triceps Surae Muscles in Recreationally Active Young Adult Males. Appl. Sci. 12, (2022).

    BACKGROUND
  • Hill M, Rosicka K, Wdowski M. Effect of sex and fatigue on quiet standing and dynamic balance and lower extremity muscle stiffness. Eur J Appl Physiol. 2022 Jan;122(1):233-244. doi: 10.1007/s00421-021-04831-0. Epub 2021 Oct 20.

    PMID: 34669045BACKGROUND
  • Hill MW, Wdowski MM, Rosicka K, Kay AD, Muehlbauer T. Exploring the relationship of static and dynamic balance with muscle mechanical properties of the lower limbs in healthy young adults. Front Physiol. 2023 May 26;14:1168314. doi: 10.3389/fphys.2023.1168314. eCollection 2023.

    PMID: 37304823BACKGROUND
  • Bizzini M, Mannion AF. Reliability of a new, hand-held device for assessing skeletal muscle stiffness. Clin Biomech (Bristol). 2003 Jun;18(5):459-61. doi: 10.1016/s0268-0033(03)00042-1.

    PMID: 12763442BACKGROUND
  • Langevin HM, Stevens-Tuttle D, Fox JR, Badger GJ, Bouffard NA, Krag MH, Wu J, Henry SM. Ultrasound evidence of altered lumbar connective tissue structure in human subjects with chronic low back pain. BMC Musculoskelet Disord. 2009 Dec 3;10:151. doi: 10.1186/1471-2474-10-151.

    PMID: 19958536BACKGROUND
  • Barnes KR, Kilding AE. Running economy: measurement, norms, and determining factors. Sports Med Open. 2015 Dec;1(1):8. doi: 10.1186/s40798-015-0007-y. Epub 2015 Mar 27.

    PMID: 27747844BACKGROUND
  • Paton CD, Hopkins WG. Combining explosive and high-resistance training improves performance in competitive cyclists. J Strength Cond Res. 2005 Nov;19(4):826-30. doi: 10.1519/R-16334.1.

    PMID: 16287351BACKGROUND
  • Costa, V. P. Efeitos de um bloco semanal de treinamento intervalado de alta intensidade nos índices fisiológicos e performance de ciclistas competitivos. (Universidade Federal de Santa Catarina, 2014).

    BACKGROUND
  • Jamnick NA, Botella J, Pyne DB, Bishop DJ. Manipulating graded exercise test variables affects the validity of the lactate threshold and V ⁢ O 2 ⁢ peak . PLoS One. 2018 Jul 30;13(7):e0199794. doi: 10.1371/journal.pone.0199794. eCollection 2018.

    PMID: 30059543BACKGROUND
  • Amann M, Subudhi A, Foster C. Influence of testing protocol on ventilatory thresholds and cycling performance. Med Sci Sports Exerc. 2004 Apr;36(4):613-22. doi: 10.1249/01.mss.0000122076.21804.10.

    PMID: 15064589BACKGROUND
  • Rohrken G, Held S, Donath L. Six Weeks of Polarized Versus Moderate Intensity Distribution: A Pilot Intervention Study. Front Physiol. 2020 Nov 12;11:534688. doi: 10.3389/fphys.2020.534688. eCollection 2020.

    PMID: 33281607BACKGROUND
  • De Pauw K, Roelands B, Cheung SS, de Geus B, Rietjens G, Meeusen R. Guidelines to classify subject groups in sport-science research. Int J Sports Physiol Perform. 2013 Mar;8(2):111-22. doi: 10.1123/ijspp.8.2.111.

    PMID: 23428482BACKGROUND
  • Kuipers H, Rietjens G, Verstappen F, Schoenmakers H, Hofman G. Effects of stage duration in incremental running tests on physiological variables. Int J Sports Med. 2003 Oct;24(7):486-91. doi: 10.1055/s-2003-42020.

    PMID: 12968205BACKGROUND
  • Mugele H, Plummer A, Baritello O, Towe M, Brecht P, Mayer F. Accuracy of training recommendations based on a treadmill multistage incremental exercise test. PLoS One. 2018 Oct 11;13(10):e0204696. doi: 10.1371/journal.pone.0204696. eCollection 2018.

    PMID: 30307961BACKGROUND
  • Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-8. doi: 10.5271/sjweh.1815.

    PMID: 2345867BACKGROUND
  • Possamai LT, Borszcz FK, de Aguiar RA, de Lucas RD, Turnes T. Agreement of maximal lactate steady state with critical power and physiological thresholds in rowing. Eur J Sport Sci. 2022 Mar;22(3):371-380. doi: 10.1080/17461391.2021.1874541. Epub 2021 Feb 8.

    PMID: 33428539BACKGROUND
  • Schlickmann, J. Suplementação com bicarbonato de sódio: influência sobre o desempenho, respostas fisiológicas e neuromusculares durante e após o exercício supramáximo no ciclismo. (2012)

    BACKGROUND
  • Bentley DJ, McNaughton LR, Batterham AM. Prolonged stage duration during incremental cycle exercise: effects on the lactate threshold and onset of blood lactate accumulation. Eur J Appl Physiol. 2001 Aug;85(3-4):351-7. doi: 10.1007/s004210100452.

    PMID: 11560091BACKGROUND
  • Binder RK, Wonisch M, Corra U, Cohen-Solal A, Vanhees L, Saner H, Schmid JP. Methodological approach to the first and second lactate threshold in incremental cardiopulmonary exercise testing. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):726-34. doi: 10.1097/HJR.0b013e328304fed4.

    PMID: 19050438BACKGROUND
  • Asplund CA, O'Connor FG, Noakes TD. Exercise-associated collapse: an evidence-based review and primer for clinicians. Br J Sports Med. 2011 Nov;45(14):1157-62. doi: 10.1136/bjsports-2011-090378. Epub 2011 Sep 26.

    PMID: 21948122BACKGROUND
  • Van Hooren B, Peake JM. Do We Need a Cool-Down After Exercise? A Narrative Review of the Psychophysiological Effects and the Effects on Performance, Injuries and the Long-Term Adaptive Response. Sports Med. 2018 Jul;48(7):1575-1595. doi: 10.1007/s40279-018-0916-2.

    PMID: 29663142BACKGROUND
  • Anley C, Noakes T, Collins M, Schwellnus MP. A comparison of two treatment protocols in the management of exercise-associated postural hypotension: a randomised clinical trial. Br J Sports Med. 2011 Nov;45(14):1113-8. doi: 10.1136/bjsm.2010.071951. Epub 2010 Jun 28.

    PMID: 20584756BACKGROUND
  • Ostrow CL. Use of the Trendelenburg position by critical care nurses: Trendelenburg survey. Am J Crit Care. 1997 May;6(3):172-6.

    PMID: 9131195BACKGROUND
  • WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138650/

    PMID: 23741774BACKGROUND
  • Chen G, Wu J, Chen G, Lu Y, Ren W, Xu W, Xu X, Wu Z, Guan Y, Zheng Y, Qiu B. Reliability of a portable device for quantifying tone and stiffness of quadriceps femoris and patellar tendon at different knee flexion angles. PLoS One. 2019 Jul 31;14(7):e0220521. doi: 10.1371/journal.pone.0220521. eCollection 2019.

    PMID: 31365582BACKGROUND
  • Christiansen L, Larsen MN, Madsen MJ, Grey MJ, Nielsen JB, Lundbye-Jensen J. Long-term motor skill training with individually adjusted progressive difficulty enhances learning and promotes corticospinal plasticity. Sci Rep. 2020 Sep 24;10(1):15588. doi: 10.1038/s41598-020-72139-8.

    PMID: 32973251BACKGROUND
  • Jedrzejewski G, Kasper-Jedrzejewska M, Dolibog P, Szygula R, Schleip R, Halski T. The Rolf Method of Structural Integration on Fascial Tissue Stiffness, Elasticity, and Superficial Blood Perfusion in Healthy Individuals: The Prospective, Interventional Study. Front Physiol. 2020 Sep 15;11:1062. doi: 10.3389/fphys.2020.01062. eCollection 2020.

    PMID: 33041843BACKGROUND
  • Dos Santos Amorim M, Sinhorim L, Wagner J, de Paula Lemos F, Schleip R, Sonza A, Santos GM. Acute effects of myofascial reorganization on trapezius muscle oxygenation in individuals with nonspecific neck pain. J Bodyw Mov Ther. 2022 Jan;29:286-290. doi: 10.1016/j.jbmt.2021.10.010. Epub 2021 Oct 21.

    PMID: 35248284BACKGROUND
  • Franca MED, Sinhorim L, Martins DF, Schleip R, Machado-Pereira NAMM, de Souza GM, Horewicz VV, Santos GM. Manipulation of the Fascial System Applied During Acute Inflammation of the Connective Tissue of the Thoracolumbar Region Affects Transforming Growth Factor-beta1 and Interleukin-4 Levels: Experimental Study in Mice. Front Physiol. 2020 Dec 3;11:587373. doi: 10.3389/fphys.2020.587373. eCollection 2020.

    PMID: 33424619BACKGROUND
  • Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.

    PMID: 29403314BACKGROUND
  • Cohen, J. Statistical Power Analysis for the Behavioral Sciences. (Lawrence Erlbaum Associates, 1988).

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be blinded to which group they will belong, as they never had contact to the technique investigated. The statistical analysis will be blinded as well, and the statistical will not know which is the experimental or the placebo group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm Randomized Clinical Trial, presenting a placebo and a experimental group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2024

First Posted

July 3, 2024

Study Start

April 15, 2024

Primary Completion

July 31, 2024

Study Completion

December 31, 2025

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations