InflammationNCT02902315
Antioxidants Combined With Cryotherapy on Inflammatory Response After Resistance Exercise in Untrained Volunteers
A study testing Cryotherapy, Vitamins C and E and Vitamins C and E associated with cryotherapy in people with Inflammation and Oxidative Stress, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Oxidative Stress, Pain
- What is being tested?
- Cryotherapy, Vitamins C and E and Vitamins C and E associated with cryotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jan 2017to 12 Jul 2017
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande
Rio Grande, Rio Grande do Sul, 96200-190
About this study
Official title: Vitamins C and E Combined With Cryotherapy on the Pain, Oxidative Stress and Inflammatory Response After Resistance Exercise Session in Untrained Volunteers
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.
Read the 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.
- Conditions
- Inflammation, Oxidative Stress, Pain
- Being tested
- Cryotherapy, Vitamins C and E, Vitamins C and E associated with cryotherapy, Placebo
- Keywords
- Muscle soreness, Free radicals, Ascorbic acid, Alpha-Tocopherol, Cryotherapy, Exercise tolerance, Resistance training
- Medical subject headings
- Inflammation, Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Also called Hypothermia
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 EOther
Also called Ascorbic acid, alfa-tocopherol
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 cryotherapyOther
Also called Vitamins C and E, Hypothermia
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.
PlaceboOther
Also called Control
The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.
| Study group | Role | What they receive |
|---|---|---|
| 1ª Session of resistance exercises | Active comparator | 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. Receives: Other: Cryotherapy; Other: Vitamins C and E; Other: Vitamins C and E associated with cryotherapy; Other: Placebo |
| 2ª Session of resistance exercises | Active comparator | 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. Receives: Other: Cryotherapy; Other: Vitamins C and E; Other: Vitamins C and E associated with cryotherapy; Other: Placebo |
| 3ª Session of resistance exercises | Active comparator | 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. Receives: Other: Cryotherapy; Other: Vitamins C and E; Other: Vitamins C and E associated with cryotherapy; Other: Placebo |
| 4ª Session of resistance exercises | Active comparator | 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. Receives: Other: Cryotherapy; Other: Vitamins C and E; Other: Vitamins C and E associated with cryotherapy; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessed 24 hours after resistance exercise session
Secondary outcomes (11)
Erythrocytes (/ mm3)
Blood count (/ mm3).
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Platelets (/ mm3)
Blood count (/ mm3).
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Leukogram (/ mm3)
Differential white blood cell counts (/ mm3). Total leukocytes, segmented neutrophils, young neutrophils (rods), monocytes, lymphocytes and eosinophils.
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
C reactive protein (mg/dL)
Inflammatory markers
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Creatine kinase (U/L)
Inflammatory markers
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Lactate dehydrogenase (mmol/L)
Inflammatory markers
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Fibrinogen (mg/dL)
Inflammatory markers.
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Reactive oxygen species (ROS = relative area)
Oxidative stress parameters: damage molecular.
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
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)
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Superoxide dismutase (SOD = units / mg protein)
Oxidative stress parameters: enzymatic molecular defense
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Catalase (units / mg protein)
Oxidative stress parameters: enzymatic molecular defense
Measured: Baseline (before), and at 0, 30 and 120 minutes after exercises.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start4 Jan 2017
- Primary completion10 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Ulisses Signori, Universidade Federal de Santa Maria
- Investigators
- Luis U Signori, PhD, Principal investigator, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902315
- Sponsor's protocol ID
- UFSantaMaria2
- Status last verified
- Jul 2017
- First submitted
- 19 Aug 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20544483Nadler 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.
PubMed 16858479Bryer 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.
PubMed 16948483Cheung 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.
PubMed 12617692Hudson 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.
PubMed 18379219Malm 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.
PubMed 11080266Finaud 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.
PubMed 16573358Lewis 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.
PubMed 22341015Nakajima 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.
PubMed 20640440Rietjens 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.
PubMed 18046185Silva 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.
PubMed 19859781Teixeira 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.
PubMed 17197574Traber 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.
PubMed 21664268
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamins C and E Combined With Cryotherapy on the Pain, Oxidative Stress and Inflammatory Response After Resistance Exercise Session in Untrained Volunteers
- ClinicalTrials.gov ID
- NCT02902315
- Acronym / sponsor ID
- UFSantaMaria2
- Conditions
- Inflammation, Oxidative Stress, Pain
- Keywords
- Muscle soreness, Free radicals, Ascorbic acid, Alpha-Tocopherol, Cryotherapy, Exercise tolerance, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1ª Session of resistance exercises | Active comparator | Other: Cryotherapy, Other: Vitamins C and E, Other: Vitamins C and E associated with cryotherapy, Other: PlaceboExercise 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. |
| 2ª Session of resistance exercises | Active comparator | Other: Cryotherapy, Other: Vitamins C and E, Other: Vitamins C and E associated with cryotherapy, Other: PlaceboExercise 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. |
| 3ª Session of resistance exercises | Active comparator | Other: Cryotherapy, Other: Vitamins C and E, Other: Vitamins C and E associated with cryotherapy, Other: PlaceboExercise 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. |
| 4ª Session of resistance exercises | Active comparator | Other: Cryotherapy, Other: Vitamins C and E, Other: Vitamins C and E associated with cryotherapy, Other: PlaceboExercise 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| CryotherapyAlso: HypothermiaThe 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 | 1ª Session of resistance exercises, 2ª Session of resistance exercises, 3ª Session of resistance exercises, 4ª Session of resistance exercises |
| Vitamins C and EAlso: Ascorbic acid, alfa-tocopherolThe 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 | 1ª Session of resistance exercises, 2ª Session of resistance exercises, 3ª Session of resistance exercises, 4ª Session of resistance exercises |
| Vitamins C and E associated with cryotherapyAlso: Vitamins C and E, HypothermiaThe 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 | 1ª Session of resistance exercises, 2ª Session of resistance exercises, 3ª Session of resistance exercises, 4ª Session of resistance exercises |
| PlaceboAlso: ControlThe volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved. | Other | 1ª Session of resistance exercises, 2ª Session of resistance exercises, 3ª Session of resistance exercises, 4ª Session of resistance exercises |
Primary outcome
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).
11 secondary outcomes
Erythrocytes (/ mm3)
Time frame: 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.
Leukogram (/ mm3)
Time frame: 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.
Creatine kinase (U/L)
Time frame: 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.
Fibrinogen (mg/dL)
Time frame: 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.
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.
Superoxide dismutase (SOD = units / mg protein)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Background: PubMed 20544483Carvalho 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.
- Background: PubMed 16858479Nadler 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.
- Background: PubMed 16948483Bryer 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.
- Background: PubMed 12617692Cheung 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.
- Background: PubMed 18379219Hudson 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.
- Background: PubMed 11080266Malm 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.
- Background: PubMed 16573358Finaud 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.
- Background: PubMed 22341015Lewis 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.
- Background: PubMed 20640440Nakajima 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.
- Background: PubMed 18046185Rietjens 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.
- Background: PubMed 19859781Silva 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.
- BackgroundTeixeira 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.
- 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.
Luis U Signori, PhD principal investigator
Universidade Federal de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy, Vitamins C and E and Vitamins C and E associated with cryotherapy in people with Inflammation and Oxidative Stress, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 2017. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Delayed onset muscle soreness (points) (time frame: Assessed 24 hours after resistance exercise session). 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 NCT02902315, which also lists 16 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 17 Jul 2017.