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Antioxidants Combined With Cryotherapy on Inflammatory Response After Resistance Exercise in Untrained Volunteers

Primary Purpose

Inflammation, Oxidative Stress, Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cryotherapy
Vitamins C and E
Vitamins C and E associated with cryotherapy
Placebo
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring Muscle soreness, Free radicals, Ascorbic acid, Alpha-Tocopherol, Cryotherapy, Exercise tolerance, Resistance training

Eligibility Criteria

20 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Federal do Rio Grande

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1ª Session of resistance exercises

2ª Session of resistance exercises

3ª Session of resistance exercises

4ª Session of resistance exercises

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Erythrocytes (/ mm3)
Blood count (/ mm3).
Platelets (/ mm3)
Blood count (/ mm3).
Leukogram (/ mm3)
Differential white blood cell counts (/ mm3). Total leukocytes, segmented neutrophils, young neutrophils (rods), monocytes, lymphocytes and eosinophils.
C reactive protein (mg/dL)
Inflammatory markers
Creatine kinase (U/L)
Inflammatory markers
Lactate dehydrogenase (mmol/L)
Inflammatory markers
Fibrinogen (mg/dL)
Inflammatory markers.
Reactive oxygen species (ROS = relative area)
Oxidative stress parameters: damage molecular.
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)
Superoxide dismutase (SOD = units / mg protein)
Oxidative stress parameters: enzymatic molecular defense
Catalase (units / mg protein)
Oxidative stress parameters: enzymatic molecular defense

Full Information

First Posted
August 19, 2016
Last Updated
July 12, 2017
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT02902315
Brief Title
Antioxidants Combined With Cryotherapy on Inflammatory Response After Resistance Exercise in Untrained Volunteers
Official Title
Vitamins C and E Combined With Cryotherapy on the Pain, Oxidative Stress and Inflammatory Response After Resistance Exercise Session in Untrained Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Oxidative Stress, Pain
Keywords
Muscle soreness, Free radicals, Ascorbic acid, Alpha-Tocopherol, Cryotherapy, Exercise tolerance, Resistance training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1ª Session of resistance exercises
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2ª Session of resistance exercises
Arm Type
Active Comparator
Arm Description
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.
Arm Title
3ª Session of resistance exercises
Arm Type
Active Comparator
Arm Description
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.
Arm Title
4ª Session of resistance exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Other Intervention Name(s)
Hypothermia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vitamins C and E
Other Intervention Name(s)
Ascorbic acid, alfa-tocopherol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vitamins C and E associated with cryotherapy
Other Intervention Name(s)
Vitamins C and E, Hypothermia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.
Primary Outcome Measure Information:
Title
Delayed onset muscle soreness (points)
Description
Twenty-four hours after the exercise session, the pain or delayed onset muscle soreness (DOMS) was evaluated by visual analog scale (0 - 10 points).
Time Frame
Assessed 24 hours after resistance exercise session
Secondary Outcome Measure Information:
Title
Erythrocytes (/ mm3)
Description
Blood count (/ mm3).
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
Platelets (/ mm3)
Description
Blood count (/ mm3).
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
Leukogram (/ mm3)
Description
Differential white blood cell counts (/ mm3). Total leukocytes, segmented neutrophils, young neutrophils (rods), monocytes, lymphocytes and eosinophils.
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
C reactive protein (mg/dL)
Description
Inflammatory markers
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
Creatine kinase (U/L)
Description
Inflammatory markers
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
Lactate dehydrogenase (mmol/L)
Description
Inflammatory markers
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
Fibrinogen (mg/dL)
Description
Inflammatory markers.
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
Reactive oxygen species (ROS = relative area)
Description
Oxidative stress parameters: damage molecular.
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
Anti-oxidant capacity against peroxyl radicals (ACAP = deference of the areas (wtih ABAP / without ABAP)
Description
Oxidative stress parameters: damage molecular , 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.
Title
Superoxide dismutase (SOD = units / mg protein)
Description
Oxidative stress parameters: enzymatic molecular defense
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.
Title
Catalase (units / mg protein)
Description
Oxidative stress parameters: enzymatic molecular defense
Time Frame
Baseline (before), and at 0, 30 and 120 minutes after exercises.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis U Signori, PhD
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande
City
Rio Grande
State/Province
RS
ZIP/Postal Code
96200-190
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Antioxidants Combined With Cryotherapy on Inflammatory Response After Resistance Exercise in Untrained Volunteers

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