- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02902315
Antioxidants Combined With Cryotherapy on Inflammatory Response After Resistance Exercise in Untrained Volunteers
Vitamins C and E Combined With Cryotherapy on the Pain, Oxidative Stress and Inflammatory Response After Resistance Exercise Session in Untrained Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
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Rio Grande, RS, Brazil, 96200-190
- Universidade Federal do Rio Grande
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1ª Session of resistance exercises
Exercise session are based on previous studies (TEIXEIRA et al., 2012; TEIXEIRA et al., 2014) and will be randomized according to the sequence of exercises (extensor bench, squat and leg press) and the interventions by drawing sealed brown envelopes.
Forty minutes before basal blood collection and of the exercise session the volunteers will receive placebo (two pills wheat flour) and the remaining procedures will be conserved.
The exercise sessions were comprised of four series of 10 maximum repetitions, with an interval of one minute between series and two minutes between exercises.
Before the 10 maximum repetitions test and data collection, standard instructions will be given concerning the experimental procedure and execution technique of the exercises.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.
Other Names:
|
|
Active Comparator: 2ª Session of resistance exercises
Exercise session are based on previous studies (TEIXEIRA et al., 2012; TEIXEIRA et al., 2014) and will be randomized according to the sequence of exercises (extensor bench, squat and leg press) and the interventions by drawing sealed brown envelopes.
Forty minutes before basal blood collection and of the exercise session the volunteers will receive placebo (two pills wheat flour) and the remaining procedures will be conserved.
The exercise sessions were comprised of four series of 10 maximum repetitions, with an interval of one minute between series and two minutes between exercises.
Before the 10 maximum repetitions test and data collection, standard instructions will be given concerning the experimental procedure and execution technique of the exercises.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.
Other Names:
|
|
Active Comparator: 3ª Session of resistance exercises
Exercise session are based on previous studies (TEIXEIRA et al., 2012; TEIXEIRA et al., 2014) and will be randomized according to the sequence of exercises (extensor bench, squat and leg press) and the interventions by drawing sealed brown envelopes.
Forty minutes before basal blood collection and of the exercise session the volunteers will receive placebo (two pills wheat flour) and the remaining procedures will be conserved.
The exercise sessions were comprised of four series of 10 maximum repetitions, with an interval of one minute between series and two minutes between exercises.
Before the 10 maximum repetitions test and data collection, standard instructions will be given concerning the experimental procedure and execution technique of the exercises.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.
Other Names:
|
|
Active Comparator: 4ª Session of resistance exercises
Exercise session are based on previous studies (TEIXEIRA et al., 2012; TEIXEIRA et al., 2014) and will be randomized according to the sequence of exercises (extensor bench, squat and leg press) and the interventions by drawing sealed brown envelopes.
Forty minutes before basal blood collection and of the exercise session the volunteers will receive placebo (two pills wheat flour) and the remaining procedures will be conserved.
The exercise sessions were comprised of four series of 10 maximum repetitions, with an interval of one minute between series and two minutes between exercises.
Before the 10 maximum repetitions test and data collection, standard instructions will be given concerning the experimental procedure and execution technique of the exercises.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed onset muscle soreness (points)
Time Frame: Assessed 24 hours after resistance exercise session
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Erythrocytes (/ mm3)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Blood count (/ mm3).
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
|
Platelets (/ mm3)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Blood count (/ mm3).
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
|
Leukogram (/ mm3)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
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.
|
|
C reactive protein (mg/dL)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Inflammatory markers
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
|
Creatine kinase (U/L)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Inflammatory markers
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
|
Lactate dehydrogenase (mmol/L)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Inflammatory markers
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
|
Fibrinogen (mg/dL)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Inflammatory markers.
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
|
Reactive oxygen species (ROS = relative area)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Oxidative stress parameters: damage molecular.
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
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Anti-oxidant capacity against peroxyl radicals (ACAP = deference of the areas (wtih ABAP / without ABAP)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
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.
|
|
Superoxide dismutase (SOD = units / mg protein)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Oxidative stress parameters: enzymatic molecular defense
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
|
Catalase (units / mg protein)
Time Frame: Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Oxidative stress parameters: enzymatic molecular defense
|
Baseline (before), and at 0, 30 and 120 minutes after exercises.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Luis U Signori, PhD, Universidade Federal de Santa Maria
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
- 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.
- 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. doi: 10.1123/ijsnem.16.3.270.
- 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.
- 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(Pt 1):243-62. doi: 10.1111/j.1469-7793.2000.00243.x.
- Finaud J, Lac G, Filaire E. Oxidative stress : relationship with exercise and training. Sports Med. 2006;36(4):327-58. doi: 10.2165/00007256-200636040-00004.
- 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.
- 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. doi: 10.1249/mss.0b013e318157936d. Erratum In: Med Sci Sports Exerc. 2008 Mar;40(3):591.
- 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.
- 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
- 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. doi: 10.1177/0363546506294569. Epub 2006 Dec 1.
- Wilcock IM, Cronin JB, Hing WA. Physiological response to water immersion: a method for sport recovery? Sports Med. 2006;36(9):747-65. doi: 10.2165/00007256-200636090-00003.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFSantaMaria2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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