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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02902315
Other study ID # UFSantaMaria2
Secondary ID
Status Completed
Phase N/A
First received August 19, 2016
Last updated July 12, 2017
Start date January 4, 2017
Est. completion date July 12, 2017

Study information

Verified date July 2017
Source Universidade Federal de Santa Maria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acutely resistance exercise induces inflammatory responses and leukocytosis arising of oxidative stress, that clinically manifested by pain and/or delayed onset muscle soreness (DOMS). Beginners in resistance exercise programs are more vulnerable to the effects of oxidative stress as they exhibit lower antioxidant capacity, greater lipid peroxidation and present increased perception of pain after exercises that may lead to abandonment the exercises practice. Vitamins C and E are exogenous antioxidants which are able to prevent damages caused by oxidative stress. Cryotherapy decreases temperature and reduced generation of reactive oxygen species. The aim of the present research are to investigate the effects of the concomitant of vitamins and of cryotherapy on leukocytosis, inflammatory markers, oxidative stress parameters and pain in untrained individuals submitted to a resistance exercise session.


Description:

The regular practice of physical exercises promotes anti-inflammatory effects, which reduces the mortality from all causes, especially by cardiovascular diseases. On the other hand, physical exercise induces acute inflammatory responses. Acute resistance exercises provoke mechanical and metabolic stress which may vary depending on the intensity, specificity, volume and workload. During these exercises, reactive oxygen and nitrogen species (RONS) are formed and, when its production exceeds the antioxidant enzymatic capacity (Superoxide dismutase, Catalase and Glutathione peroxidase) and non-enzymatic capacity (vitamins A, C, E and uric acid) results in oxidation of cell constituents. This state of oxidative stress promotes one inflammatory response, activation and mobilization of circulating white blood cells and induce a transitory leukocytosis, that are observed during and immediately after resistance exercises. The local neutrophilia induces the amplification of inflammatory response by feedback resulting in activation and/or mobilization of the more white blood cells. This sequence of physiological events leads to muscular remodeling although, during such process, occur functional insufficiency and the sensation of pain and/or delayed onset muscular soreness (DOMS), which deserves special attention, once may lead to interruption or abandonment of exercises, especially concerning beginners in this practice.

Numerous preventive approaches have been studied intending to minimize the inflammatory response caused by resistance exercises, including the supplementation with vitamins C (ascorbic acid) and E (alfa-tocopherol). These vitamins are exogenous antioxidants which are able to prevent damages caused by RONS and consequently attenuate the oxidative damage induced by resistance exercises. Cryotherapy is defined as the therapeutic application of any substance that removes heat from the body, thus lowering the temperature of tissues. Immersion in cold water (≤ 15ºC) is a common method of heat reduction. Cryotherapy attenuates microvascular dysfunction, and decreases temperature, metabolism and oxygen demand in the electron transport chain. As a consequence, lower amounts of RONS are produced less damage was caused to adjacent molecules. The aim of the present research are to investigate the effects of the concomitant supplementation of vitamins (C and E) and cryotherapy (immersion in water at 15ºC) on leukocytosis, inflammatory markers, oxidative stress parameters and pain in untrained individuals submitted to a resistance exercise session.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 12, 2017
Est. primary completion date July 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- Age between 20 and 35 years, body mass index (MBI: kg/m2) lower than 30, non-smokers, did not practice physical and/or regular physical exercises (less than two times per week), presented no previous diagnosis of chronic diseases (rheumatic, cardiovascular, metabolic, neurological, oncologic, immunological or hematologic disorders), is not engaged in any diet programs and is not making use of medication.

Exclusion Criteria:

- Inflammatory response (ultrasensitive C reactive protein >3 mg/dL), hyperglycemia (>100 mg/dL), leukocytosis, hyperthermia (>38ºC), changes in the systemic blood pressure (>140/90 mmHg) and/or any symptom of pain or discomfort

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cryotherapy
The intervention will consist of the application of hypothermia by immersion of the lower limbs of water on individuals to 15ºC for a period of 10 minutes immediately after the exercise protocol.
Vitamins C and E
The session of resistance exercises with intervention will be based on the supplementation with vitamin C (1000 mg) and vitamin E (800 IU) by oral intake (100mL of water) 40 minutes before basal blood collection.
Vitamins C and E associated with cryotherapy
The session of resistance exercises with intervention will be based on the supplementation with vitamin C (1000 mg) and vitamin E (800 IU) by oral intake (100mL of water) 40 minutes before basal blood collection. The intervention will consist of the application of hypothermia by immersion of the lower limbs of water on individuals to 15ºC for a period of 10 minutes immediately after the exercise protocol.
Placebo
The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.

Locations

Country Name City State
Brazil Universidade Federal do Rio Grande Rio Grande RS

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

References & Publications (16)

Bryer SC, Goldfarb AH. Effect of high dose vitamin C supplementation on muscle soreness, damage, function, and oxidative stress to eccentric exercise. Int J Sport Nutr Exerc Metab. 2006 Jun;16(3):270-80. — View Citation

Carvalho N, Puntel G, Correa P, Gubert P, Amaral G, Morais J, Royes L, da Rocha J, Soares F. Protective effects of therapeutic cold and heat against the oxidative damage induced by a muscle strain injury in rats. J Sports Sci. 2010 Jul;28(9):923-35. doi: 10.1080/02640414.2010.481722. — View Citation

Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. Review. — View Citation

Finaud J, Lac G, Filaire E. Oxidative stress : relationship with exercise and training. Sports Med. 2006;36(4):327-58. Review. — View Citation

Hudson MB, Hosick PA, McCaulley GO, Schrieber L, Wrieden J, McAnulty SR, Triplett NT, McBride JM, Quindry JC. The effect of resistance exercise on humoral markers of oxidative stress. Med Sci Sports Exerc. 2008 Mar;40(3):542-8. doi: 10.1249/MSS.0b013e31815daf89. — View Citation

Lewis PB, Ruby D, Bush-Joseph CA. Muscle soreness and delayed-onset muscle soreness. Clin Sports Med. 2012 Apr;31(2):255-62. doi: 10.1016/j.csm.2011.09.009. Epub 2011 Nov 23. Review. — View Citation

Malm C, Nyberg P, Engstrom M, Sjodin B, Lenkei R, Ekblom B, Lundberg I. Immunological changes in human skeletal muscle and blood after eccentric exercise and multiple biopsies. J Physiol. 2000 Nov 15;529 Pt 1:243-62. — View Citation

Nadler SF, Weingand K, Kruse RJ. The physiologic basis and clinical applications of cryotherapy and thermotherapy for the pain practitioner. Pain Physician. 2004 Jul;7(3):395-9. — View Citation

Nakajima T, Kurano M, Hasegawa T, Takano H, Iida H, Yasuda T, Fukuda T, Madarame H, Uno K, Meguro K, Shiga T, Sagara M, Nagata T, Maemura K, Hirata Y, Yamasoba T, Nagai R. Pentraxin3 and high-sensitive C-reactive protein are independent inflammatory markers released during high-intensity exercise. Eur J Appl Physiol. 2010 Nov;110(5):905-13. doi: 10.1007/s00421-010-1572-x. Epub 2010 Jul 17. — View Citation

Rietjens SJ, Beelen M, Koopman R, VAN Loon LJ, Bast A, Haenen GR. A single session of resistance exercise induces oxidative damage in untrained men. Med Sci Sports Exerc. 2007 Dec;39(12):2145-51. Erratum in: Med Sci Sports Exerc. 2008 Mar;40(3):591. — View Citation

Schaser KD, Disch AC, Stover JF, Lauffer A, Bail HJ, Mittlmeier T. Prolonged superficial local cryotherapy attenuates microcirculatory impairment, regional inflammation, and muscle necrosis after closed soft tissue injury in rats. Am J Sports Med. 2007 Jan;35(1):93-102. Epub 2006 Dec 1. — View Citation

Silva LA, Pinho CA, Silveira PC, Tuon T, De Souza CT, Dal-Pizzol F, Pinho RA. Vitamin E supplementation decreases muscular and oxidative damage but not inflammatory response induced by eccentric contraction. J Physiol Sci. 2010 Jan;60(1):51-7. doi: 10.1007/s12576-009-0065-3. Epub 2009 Oct 27. — View Citation

Teixeira ADO, Franco OS, Borges MM, et al.. The importance of adjustments for changes in plasma volume in the interpretation of hematological and inflmmatory responses after resistance exercise. J Exerc Physiol 17:72-83, 2014.

Teixeira ADO, Paulitsch FDS, Umpierre MDM, et al.. Inflammatory response after session of resistance exercises in untrained volunteers. Acta Sci Heal Sci 37:31-39, 2015. doi: 10.4025/actascihealthsci.v37i1.24149

Traber MG, Stevens JF. Vitamins C and E: beneficial effects from a mechanistic perspective. Free Radic Biol Med. 2011 Sep 1;51(5):1000-13. doi: 10.1016/j.freeradbiomed.2011.05.017. Epub 2011 May 25. Review. — View Citation

Wilcock IM, Cronin JB, Hing WA. Physiological response to water immersion: a method for sport recovery? Sports Med. 2006;36(9):747-65. Review. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Delayed onset muscle soreness (points) Twenty-four hours after the exercise session, the pain or delayed onset muscle soreness (DOMS) was evaluated by visual analog scale (0 - 10 points). Assessed 24 hours after resistance exercise session
Secondary Erythrocytes (/ mm3) Blood count (/ mm3). Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Platelets (/ mm3) Blood count (/ mm3). Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Leukogram (/ mm3) Differential white blood cell counts (/ mm3). Total leukocytes, segmented neutrophils, young neutrophils (rods), monocytes, lymphocytes and eosinophils. Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary C reactive protein (mg/dL) Inflammatory markers Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Creatine kinase (U/L) Inflammatory markers Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Lactate dehydrogenase (mmol/L) Inflammatory markers Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Fibrinogen (mg/dL) Inflammatory markers. Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Reactive oxygen species (ROS = relative area) Oxidative stress parameters: damage molecular. Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Anti-oxidant capacity against peroxyl radicals (ACAP = deference of the areas (wtih ABAP / without ABAP) Oxidative stress parameters: damage molecular , anti-oxidant capacity against peroxyl radicals (ACAP = deference of the areas (wtih ABAP / without ABAP) Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Superoxide dismutase (SOD = units / mg protein) Oxidative stress parameters: enzymatic molecular defense Baseline (before), and at 0, 30 and 120 minutes after exercises.
Secondary Catalase (units / mg protein) Oxidative stress parameters: enzymatic molecular defense Baseline (before), and at 0, 30 and 120 minutes after exercises.
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