NCT02902315

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 19, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

August 19, 2016

Last Update Submit

July 12, 2017

Conditions

Keywords

Muscle sorenessFree radicalsAscorbic acidAlpha-TocopherolCryotherapyExercise toleranceResistance training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Erythrocytes (/ mm3)

    Baseline (before), and at 0, 30 and 120 minutes after exercises.

  • Platelets (/ mm3)

    Baseline (before), and at 0, 30 and 120 minutes after exercises.

  • Leukogram (/ mm3)

    Baseline (before), and at 0, 30 and 120 minutes after exercises.

  • C reactive protein (mg/dL)

    Baseline (before), and at 0, 30 and 120 minutes after exercises.

  • Creatine kinase (U/L)

    Baseline (before), and at 0, 30 and 120 minutes after exercises.

  • +6 more secondary outcomes

Study Arms (4)

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.

Other: CryotherapyOther: Vitamins C and EOther: Vitamins C and E associated with cryotherapyOther: 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.

Other: CryotherapyOther: Vitamins C and EOther: Vitamins C and E associated with cryotherapyOther: 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.

Other: CryotherapyOther: Vitamins C and EOther: Vitamins C and E associated with cryotherapyOther: 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.

Other: CryotherapyOther: Vitamins C and EOther: Vitamins C and E associated with cryotherapyOther: Placebo

Interventions

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.

Also known as: Hypothermia
1ª Session of resistance exercises2ª Session of resistance exercises3ª Session of resistance exercises4ª Session of resistance exercises

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.

Also known as: Ascorbic acid, alfa-tocopherol
1ª Session of resistance exercises2ª Session of resistance exercises3ª Session of resistance exercises4ª Session of resistance exercises

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.

Also known as: Vitamins C and E, Hypothermia
1ª Session of resistance exercises2ª Session of resistance exercises3ª Session of resistance exercises4ª Session of resistance exercises
PlaceboOTHER

The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.

Also known as: Control
1ª Session of resistance exercises2ª Session of resistance exercises3ª Session of resistance exercises4ª Session of resistance exercises

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande

Rio Grande, Rio Grande do Sul, 96200-190, Brazil

Location

Related Publications (16)

  • 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.

    PMID: 20544483BACKGROUND
  • 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.

    PMID: 16858479BACKGROUND
  • 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.

    PMID: 16948483BACKGROUND
  • 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.

    PMID: 12617692BACKGROUND
  • 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.

    PMID: 18379219BACKGROUND
  • 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.

    PMID: 11080266BACKGROUND
  • 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.

    PMID: 16573358BACKGROUND
  • 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.

    PMID: 22341015BACKGROUND
  • 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.

    PMID: 20640440BACKGROUND
  • 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.

    PMID: 18046185BACKGROUND
  • 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.

    PMID: 19859781BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 17197574BACKGROUND
  • 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.

    PMID: 21664268BACKGROUND
  • 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.

    PMID: 16937951BACKGROUND

MeSH Terms

Conditions

InflammationPainMyalgia

Interventions

CryotherapyAscorbic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal Pain

Intervention Hierarchy (Ancestors)

TherapeuticsSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Luis U Signori, PhD

    Universidade Federal de Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 19, 2016

First Posted

September 15, 2016

Study Start

January 4, 2017

Primary Completion

July 10, 2017

Study Completion

July 12, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations