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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04201977
Other study ID # nº 047670
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date April 30, 2021

Study information

Verified date April 2021
Source Universidade Federal de Santa Maria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Delayed onset muscle soreness (DOMS) and decrease of musculoskeletal function are due to high intensity training and / or sports activities. These occur due to micro lesions of muscle tissue resulting in nociceptor sensitization. Non-pharmacological interventions to attenuate DOMS and favor muscle recovery have been studied. These interventions aim to maintain performance levels, especially in competitions. Among these interventions, cryotherapy (cold water immersion) and active recovery already have good clinical evidence. Currently a new proposal has been gaining ground for myofascial self-release (foam roller), however its mechanisms and clinical evidence are not yet well established. The aim of the present research is to compare the effects of passive recovery, active recovery, cold water immersion recovery and recovery through myofascial self-release on DOMS and the functionality of healthy volunteers undergoing resistance exercise.


Description:

The volunteers included in the study will perform an evaluation to verify the eligibility criteria, physical evaluation (weight, height, systemic blood pressure) and functional capacity to determine the exercise parameters. After will be presented to the four interventions, ie the recovery techniques after the exercises favoring their adaptation. There will be four resistance exercise sessions followed by interventions with a one week interval between each session. Interventions (passive recovery = 1, active recovery = 2, recovery with IAF = 3 and recovery with myofascial self-release = 4) will be randomized. Functionality assessments will be performed before and one hour after the intervention protocol. DOMS will be evaluated 24 and 72 hours after the exercise protocol. Evaluators will be blind to interventions.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 30, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Male, - Literate, - Normotensive volunteers, - Aged minimum18 to maximum 35 years old, - Physically active (IPAQ scale). - Body mass index (BMI: kg / m2) greater than 30 Exclusion Criteria: - Use of food supplements and medication - Consume alcoholic beverages (+ once a week) - Present of musculoskeletal disorders, - Previous diagnosis of diseases (rheumatologic, cardiovascular diseases, as well as neurological, oncological, immunological and hematological diseases) - Psychiatric and / or cognitive problems. On the day of the exams will be excluded: - Volunteers who present symptoms of musculoskeletal disorders, - Consume ergogenic substances (24h), - Consume alcoholic beverages and foods containing alcohol or caffeine (24h) - Have performedintense physical activities 72 hours before the exam.

Study Design


Intervention

Other:
Foam Roller Recovery
Myofascial self-release will be developed through the foam roller (FR), where participants will use a custom-made foam roller constructed from a hollow polyvinyl chloride tube that will have an outside diameter of 10cm and a thickness of 0.5cm and will be surrounded by neoprene foam with a thickness of 1cm. Each volunteer will be shown the technique for the 5 muscle groups involved and the technique used for each muscle group. FR will consist of 45s of rolling for each muscle in the left lower extremity, 15s of rest, 45s in the lower right extremity. They will be instructed to begin with the practice on the most distal portion of the muscle. They will be instructed to place as much tolerable body mass on the FR at all times and to roll their body mass back and forth along the roller as smoothly as possible at a rate of 50 beats per minute (ie , 1 rolling motion for 1 to 2s). The total technique time is estimated at 10 to 15min (PEARCEY et al., 2015).
Active recovery
Active recovery for 20 minutes (MIKA et al., 2016) will consist of pedaling on a stationary bike at a speed of 50 to 60 rpm. The load (49 ± 9 W) will be adjusted individually so that the heart rate is close to 100 bpm (about 50% of the theoretical maximum heart rate). This effort intensity is similar to that used in the literature (CRISAFULLI et al., 2003; FAIRCHILD et al., 2003; VANDERTHOMMED; MAKROF; DEMOULIN, 2010)
Immersion in cold water
Immersion in cold water will consist of the individual sitting in a plastic pool with water at the water level of the umbilical scar. Water temperature is between 11 and 15ºC, for a period between 10 and 15 minutes immediately after the exercise protocol (MACHADO et al., 2016b; MCDERMOTT et al., 2009). Water temperature will be controlled by adding or removing ice. This method has been applied by studies conducted by our research group (MISSAU; SIGNORI, 2017).
Passive recovery
Volunteers will be seated for 20 min after the resistance exercise session (TEIXEIRA et al., 2014a, 2014b).

Locations

Country Name City State
Brazil Luis Ulisses Signori Santa Maria Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

References & Publications (20)

Bolgla LA, Keskula DR. Reliability of lower extremity functional performance tests. J Orthop Sports Phys Ther. 1997 Sep;26(3):138-42. — View Citation

Chisholm MD, Birmingham TB, Brown J, Macdermid J, Chesworth BM. Reliability and validity of a weight-bearing measure of ankle dorsiflexion range of motion. Physiother Can. 2012 Fall;64(4):347-55. doi: 10.3138/ptc.2011-41. — View Citation

Crisafulli A, Orrù V, Melis F, Tocco F, Concu A. Hemodynamics during active and passive recovery from a single bout of supramaximal exercise. Eur J Appl Physiol. 2003 Apr;89(2):209-16. Epub 2003 Mar 4. — View Citation

Fairchild TJ, Armstrong AA, Rao A, Liu H, Lawrence S, Fournier PA. Glycogen synthesis in muscle fibers during active recovery from intense exercise. Med Sci Sports Exerc. 2003 Apr;35(4):595-602. — View Citation

Foster C, Florhaug JA, Franklin J, Gottschall L, Hrovatin LA, Parker S, Doleshal P, Dodge C. A new approach to monitoring exercise training. J Strength Cond Res. 2001 Feb;15(1):109-15. — View Citation

Giles D, Draper N, Neil W. Validity of the Polar V800 heart rate monitor to measure RR intervals at rest. Eur J Appl Physiol. 2016 Mar;116(3):563-71. doi: 10.1007/s00421-015-3303-9. Epub 2015 Dec 26. — View Citation

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. — View Citation

Latorre Román PÁ, Villar Macias FJ, García Pinillos F. Effects of a contrast training programme on jumping, sprinting and agility performance of prepubertal basketball players. J Sports Sci. 2018 Apr;36(7):802-808. doi: 10.1080/02640414.2017.1340662. Epub 2017 Jun 21. — View Citation

Machado AF, Almeida AC, Micheletti JK, Vanderlei FM, Tribst MF, Netto Junior J, Pastre CM. Dosages of cold-water immersion post exercise on functional and clinical responses: a randomized controlled trial. Scand J Med Sci Sports. 2017 Nov;27(11):1356-1363. doi: 10.1111/sms.12734. Epub 2016 Jul 19. — View Citation

McDermott BP, Casa DJ, Ganio MS, Lopez RM, Yeargin SW, Armstrong LE, Maresh CM. Acute whole-body cooling for exercise-induced hyperthermia: a systematic review. J Athl Train. 2009 Jan-Feb;44(1):84-93. doi: 10.4085/1062-6050-44.1.84. Review. — View Citation

Mika A, Oleksy L, Kielnar R, Wodka-Natkaniec E, Twardowska M, Kaminski K, Malek Z. Comparison of Two Different Modes of Active Recovery on Muscles Performance after Fatiguing Exercise in Mountain Canoeist and Football Players. PLoS One. 2016 Oct 5;11(10): — View Citation

MISSAU, E.; SIGNORI, L. U. Imersão na água fria na resposta inflamatória após exercícios resistidos. Revista Brasileria de Medina do Esporte, v. In submiss, 2017.

NARDI, A. T. DE et al. Different frequencies of transcutaneous electrical nerve stimulation on sympatho-vagal balance. Acta Scientiarum. Health Sciences, v. 39, n. 1, p. 9, 2017.

Nellessen AG, Donária L, Hernandes NA, Pitta F. Analysis of three different equations for predicting quadriceps femoris muscle strength in patients with COPD. J Bras Pneumol. 2015 Jul-Aug;41(4):305-12. doi: 10.1590/S1806-37132015000004515. English, Portug — View Citation

Pearcey GE, Bradbury-Squires DJ, Kawamoto JE, Drinkwater EJ, Behm DG, Button DC. Foam rolling for delayed-onset muscle soreness and recovery of dynamic performance measures. J Athl Train. 2015 Jan;50(1):5-13. doi: 10.4085/1062-6050-50.1.01. Epub 2014 Nov — View Citation

SIGNORI, L. U. et al. Efeito de agentes térmicos aplicados previamente a um programa de alongamentos na flexibilidade dos músculos isquiotibiais encurtados. Revista Brasileira de Medicina do Esporte, v. 14, n. 4, p. 328-331, 2008.

TEIXEIRA, A. D. O. et al. Inflammatory response after session of resistance exercises in untrained volunteers. Acta Scientiarum. Health Sciences, v. 37, n. 1, p. 31-39, 2014a.

TEIXEIRA, A. D. O. et al. The importance of adjustments for changes in plasma volume in the interpretation of hematological and inflmmatory responses after resistance exercise. Journal of Exercise Physiology, v. 17, n. 4, p. 72-83, 2014b.

Tveter AT, Dagfinrud H, Moseng T, Holm I. Health-related physical fitness measures: reference values and reference equations for use in clinical practice. Arch Phys Med Rehabil. 2014 Jul;95(7):1366-73. doi: 10.1016/j.apmr.2014.02.016. Epub 2014 Mar 5. — View Citation

Vanderthommen M, Makrof S, Demoulin C. Comparison of active and electrostimulated recovery strategies after fatiguing exercise. J Sports Sci Med. 2010 Jun 1;9(2):164-9. eCollection 2010. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Isometric peak torque Isometric peak torque will be measured by a load cell of a tensile-compression dynamometer (EMGSystem, São José dos Campos, Brazil), with a capacity of 500 Kgf and a resolution of 0.1 kg, a set of fixing cables, a A/D converter board (EMGSystem, São José dos Campos, Brazil), connected to a computer and analyzed by the software EMGSystem Lab V1.2_ 2010. For each muscle group, a minimum of 4 and a maximum of 10 measurements of each movement will be performed. This variation in the number of measurements is so that the last measurement is not the highest value during the test and so that the three highest values differ by less than 5%. For analysis will be considered the highest value (NELLESSEN et al., 2015). During the evaluations, standardized and vigorous verbal encouragement will be performed during the maneuver, with the aim of stimulating the individual to exert maximum effort during the entire muscle contraction time.Data will be presented in kgf. 30 minutes after the interventions
Secondary Subjective exertion perception Subjective exertion perception ny the Borg scale (FOSTER et al. 2001). The scale ranges from 0 (no pain) to 10 (maximum bearable pain). Data will be presented in points average. 30 minutes after the interventions
Secondary Flexibility The flexibility will be assessed by the Bank of Wells and Dilon (SIGNORI et al., 2008) and Lunge Test (CHISHOLM et al. 2012). Data will be presented in centimeter (cm). 30 minutes after the interventions
Secondary Muscle power Muscle power will be assessed by single-limb general function (Single Hop Test) (BOLGLA; KESKULA, 1997). Data will be presented in centimeter (cm). 30 minutes after the interventions
Secondary Agility Agility will be assessed by t-test (LATORRE ROMÁN ; VILLAR MACIAS; GARCÍA PINILLOS, 2017). Data will be presented in seconds (s) 30 minutes after the interventions
Secondary Speed Speed will be evaluated by 30-meter test (PEARCEY et al., 2015). Data will be presented in seconds (s). 30 minutes after the interventions
Secondary Muscle endurance Muscle fatigue strength will be assessed by the sit-up test (TVETER et al., 2014). Data will be presented by the number of repetitions. 30 minutes after the interventions
Secondary Systemic blood pressure Blood pressure (BP) monitoring (Systolic blood pressure - SBP, Diastolic Blood Pressure - DBP and Mean Blood Pressure - MBP) will be performed using a multiparametric monitor (Dixtal, model 2021, Manaus, Brazil). The cuff will be positioned on the right arm with the patient positioned in the supine position on the stretcher. Data will be presented in mmHg. 60 minutes after the interventions
Secondary Heart rate variability Heart rate variability (HRV) will be assessed before exercise and after interventions. The autonomic balance will be evaluated by the HRV, for the acquisition of the signal will be used a Polar frequency pulse model 810i (GAMELIN; BERTHOTOIN; BOSQUET, 2016). The acquisition of the electromyographic signal (ECG sampling rate - 1 kHz) of the RR interval time series will be acquired by continuous interval and will occur before and immediately after the interventions. For data collection the volunteer will remain lying supine at rest for 10 minutes and after standing for the same period of time, after the procedure will be repeated with breath control (16 movements per minute; I / E: 2 / 3) (NARDI et al., 2017). The analysis will be done by spectral power density (European Society of Cardiology & The North American Society of Pacing and Electrophysiology, 1996). Data will be presented absolute units (ms2) and your normalized units (n.u.). 60 minutes after the interventions
Secondary Delayed onset muscle soreness Delayed onset muscle soreness (DOMS) will be evaluated by visual analog scale (EVA). The scale ranges from 0 (no pain) to 10 (maximum bearable pain). DOMS will be evaluated 24, 48 and 72 hours after the exercise protocol.
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