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Phase Angle and Body Composition, Inflammatory and Oxidative Stress Biomarkers.

Primary Purpose

Body Composition, Beneficial, Oxidative Stress, Acute and Chronic Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Composition, Beneficial focused on measuring inflammatory biomarkers, Interleukines, resistance training, phase angle, oxidative stress

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement therapy, and not performing any regular physical exercise more than once a week in the six months preceding the beginning of the investigation.
  • Participants passed a diagnostic graded exercise stress test with a 12-lead electrocardiogram, reviewed by a cardiologist, and were released with no restrictions for participation in this investigation.

Exclusion Criteria:

• All subjects not participating in 85% of the total sessions of training or withdrawl

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention 1

    control group

    Arm Description

    The training group performed the resistance training (RT) program. All participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, wirh 3 sets of 10-15 repetition maximums.The RT program was performed in the following order: chest press, seated row, triceps pushdown, preacher curl, horizontal leg press, knee extension, leg curl, , and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise

    The control group did not perform any type of physical exercise during the intervention period.

    Outcomes

    Primary Outcome Measures

    Change in Phase Angle
    Spectral bioelectrical impedance device (Xitron Hydra, model 4200, Xitron Technologies, San Diego, CA, USA) was used to estimate the resistance (R), and reactance (Xc), and subsequently the PhA was calculated as arc-tangent (Xc/R) x 180°/π. The results are presented in degree
    Change in body composition
    Whole-body dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) was used to assess body fat, trunk fat and appendicular lean soft tissue. The total skeletal muscle mass (SMM) was estimated by the predictive equation proposed by Kim et al. (Kim et al., 2002). The results are presented in kg.
    Change in CRP
    Measurements of serum levels of high-sensitivity CRP were carried out using a biochemical auto-analyzer system (Dimension RxL Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations. The results are presented in milligrams per decilitre (mg/dL).
    Change in cellular hydration
    Spectral bioelectrical impedance device (Xitron Hydra, model 4200, Xitron Technologies, San Diego, CA, USA) was used to estimate the intracellular water (ICW), extracellular water (ECW), and total body water (TBW). The results are presented in liters (L)
    Change in inflammatory markers
    TNF-α, and IL-6, IL-10 were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer (Quantikine High Sensitivity Kit, R&D Systems, Minneapolis, MN) and performed in a microplate reader Perkin Elmer, model EnSpire (Waltham, MA, USA). All samples were determined in duplicate to guarantee the precision of the results. The results are presented in picograms per milliliter (pg/ml).
    Change in CATALASE (CAT)
    The CAT analysis is by measuring the decay in concentration of H2O2, and oxygen generation using the technique described by literature. The reading of the CAT reaction was carried out in a spectrophotometer, ThermoSpectronic® brand, model HELIOS-α (Waltham, MA, USA) at a wavelength of 240 nm. Results are expressed in U / mgHb .
    Change in superoxide dismutase (SOD)
    The SOD activity in erythrocytes was determined using the pyrogallol method described by literature. The reading of SOD reaction is performed in a spectrophotometer, ThermoSpectronic® brand, model HELIOS-α (Waltham, MA, USA) at a wavelength of 420 nm. Results are expressed in U / mgHb (Marklund S)
    Change in advanced oxidation protein products (AOPP)
    For measurements, advanced oxidation protein products (AOPP) were determined in the plasma using a semiautomatic method. AOPP concentrations were expressed as micromoles per liter (μmol/L) of chloramines-T equivalents.

    Secondary Outcome Measures

    change in Muscular strength
    Maximal dynamic strength was evaluated using the 1RM test assessed on chest press, knee extension, and preacher curl exercises performed in this exact order. Testing for each exercise was preceded by a warm-up set (6-10 repetitions), with approximately 50% of the estimated load used in the first attempt of the 1RM. This warm-up was also used to familiarize the subjects with the testing equipment and lifting technique. The testing procedure was initiated 2 minutes after the warm-up. The subjects were instructed to try to accomplish two repetitions with the imposed load in three attempts in both exercises. The rest period was 3 to 5 min between each attempt, and 5 min between exercises. The 1RM was recorded as the last resistance lifted in which the subject was able to complete only one single maximal execution
    Dietary intake
    Participants were instructed by a dietitian to complete a food record on three nonconsecutive days (two week days and one weekend day) pre- and post-intervention. Participants were given specific instructions regarding the recording of portion sizes and quantities to identify all food and fluid intake, in addition to viewing food models in order to enhance precision. Total energy intake, protein, carbohydrate, and lipid content were calculated using nutrition analysis software (Avanutri Processor Nutrition Software, Rio de Janeiro, Brazil; Version 3.1.4). All participants were asked to maintain their normal diet throughout the investigation period.

    Full Information

    First Posted
    October 17, 2016
    Last Updated
    June 19, 2017
    Sponsor
    Universidade Estadual de Londrina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02940145
    Brief Title
    Phase Angle and Body Composition, Inflammatory and Oxidative Stress Biomarkers.
    Official Title
    Modifications to Phase Angle After Resistance Training Are Associated With Changes in Body Composition, Inflammatory and Oxidative Stress Biomarkers in Older Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual de Londrina

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main purpose of the present study was to investigate the effects of 12 weeks of resistance training (RT) on phase angle (PhA), body composition, inflammatory and oxidative stress biomarkers, in older women and to evaluate whether RT induced adaptations on body composition, inflammatory and oxidative stress biomarkers are related to healthy adaptations in PhA.
    Detailed Description
    The investigation was carried out over a period of 16 weeks, with 12 weeks dedicated to the RT program and 4 weeks allocated for measurements. Anthropometric, body composition, and blood samples measurements were performed at weeks 1-2, and 15-16. A supervised progressive RT was performed between weeks 3-14. The CG did not perform any type of physical exercise during this period. Recruitment was carried out through newspaper and radio advertisings, and home delivery of leaflets in the central area and residential neighborhoods. All participants completed health history and physical activity questionnaires and met the following inclusion criteria: 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement therapy, and not performing any regular physical exercise more than once a week over the six months preceding the beginning of the investigation. After individual interviews, 59 volunteers were dismissed as potential candidates because they did not meet the inclusion criteria for the investigation. The remaining 51 older women were randomly divided into one of two groups: a training group that performed the RT program or a control group that did not perform any type of physical exercise. Anthropometric, body composition (DXA), phase angle, total body water (intra and extracellular water compartments; Xitron 4200 Bioimpedance Spectrum Analyzer), muscular strength (1RM), and blood sample measurements were performed pre- and post-training. Two-way analysis of variance for repeated measures was applied for intra- and inter-group comparisons. When an F-ratio was significant, Fisher's post hoc test was employed to identify mean differences. The statistical power was determined to verify the statistical power of the analysis. Pearson's correlation was used to evaluate the correlation between delta percent changes in body composition, and muscular strength, inflammatory and oxidative stress biomarkers (independent variables) with the percentage change in PhA (dependent variables). Subsequently, linear regression (bivariate analyses) was performed for all variables that presented P<0.05 in the Pearson's correlation analyses. For the multiple comparison the multivariate regression model was performed. For all statistical analyses, significance was accepted at P<0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Body Composition, Beneficial, Oxidative Stress, Acute and Chronic Inflammation
    Keywords
    inflammatory biomarkers, Interleukines, resistance training, phase angle, oxidative stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention 1
    Arm Type
    Experimental
    Arm Description
    The training group performed the resistance training (RT) program. All participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, wirh 3 sets of 10-15 repetition maximums.The RT program was performed in the following order: chest press, seated row, triceps pushdown, preacher curl, horizontal leg press, knee extension, leg curl, , and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The control group did not perform any type of physical exercise during the intervention period.
    Intervention Type
    Other
    Intervention Name(s)
    Resistance Training
    Intervention Description
    The investigation was carried out over a period of 16 weeks, with 12 weeks dedicated to the RT program and 4 weeks allocated for measurements. Anthropometric, body composition, and blood samples measurements were performed at weeks 1-2, and 15-16. A supervised progressive RT was performed between weeks 3-14. The CG did not perform any type of physical exercise during this period.
    Primary Outcome Measure Information:
    Title
    Change in Phase Angle
    Description
    Spectral bioelectrical impedance device (Xitron Hydra, model 4200, Xitron Technologies, San Diego, CA, USA) was used to estimate the resistance (R), and reactance (Xc), and subsequently the PhA was calculated as arc-tangent (Xc/R) x 180°/π. The results are presented in degree
    Time Frame
    baseline and 12 weeks
    Title
    Change in body composition
    Description
    Whole-body dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) was used to assess body fat, trunk fat and appendicular lean soft tissue. The total skeletal muscle mass (SMM) was estimated by the predictive equation proposed by Kim et al. (Kim et al., 2002). The results are presented in kg.
    Time Frame
    baseline and 12 weeks
    Title
    Change in CRP
    Description
    Measurements of serum levels of high-sensitivity CRP were carried out using a biochemical auto-analyzer system (Dimension RxL Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations. The results are presented in milligrams per decilitre (mg/dL).
    Time Frame
    baseline and 12 weeks
    Title
    Change in cellular hydration
    Description
    Spectral bioelectrical impedance device (Xitron Hydra, model 4200, Xitron Technologies, San Diego, CA, USA) was used to estimate the intracellular water (ICW), extracellular water (ECW), and total body water (TBW). The results are presented in liters (L)
    Time Frame
    baseline and 12 weeks
    Title
    Change in inflammatory markers
    Description
    TNF-α, and IL-6, IL-10 were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer (Quantikine High Sensitivity Kit, R&D Systems, Minneapolis, MN) and performed in a microplate reader Perkin Elmer, model EnSpire (Waltham, MA, USA). All samples were determined in duplicate to guarantee the precision of the results. The results are presented in picograms per milliliter (pg/ml).
    Time Frame
    Baseline and 12 weeks
    Title
    Change in CATALASE (CAT)
    Description
    The CAT analysis is by measuring the decay in concentration of H2O2, and oxygen generation using the technique described by literature. The reading of the CAT reaction was carried out in a spectrophotometer, ThermoSpectronic® brand, model HELIOS-α (Waltham, MA, USA) at a wavelength of 240 nm. Results are expressed in U / mgHb .
    Time Frame
    Baseline and 12 weeks
    Title
    Change in superoxide dismutase (SOD)
    Description
    The SOD activity in erythrocytes was determined using the pyrogallol method described by literature. The reading of SOD reaction is performed in a spectrophotometer, ThermoSpectronic® brand, model HELIOS-α (Waltham, MA, USA) at a wavelength of 420 nm. Results are expressed in U / mgHb (Marklund S)
    Time Frame
    Baseline and 12 weeks
    Title
    Change in advanced oxidation protein products (AOPP)
    Description
    For measurements, advanced oxidation protein products (AOPP) were determined in the plasma using a semiautomatic method. AOPP concentrations were expressed as micromoles per liter (μmol/L) of chloramines-T equivalents.
    Time Frame
    Baseline and 12 weeks
    Secondary Outcome Measure Information:
    Title
    change in Muscular strength
    Description
    Maximal dynamic strength was evaluated using the 1RM test assessed on chest press, knee extension, and preacher curl exercises performed in this exact order. Testing for each exercise was preceded by a warm-up set (6-10 repetitions), with approximately 50% of the estimated load used in the first attempt of the 1RM. This warm-up was also used to familiarize the subjects with the testing equipment and lifting technique. The testing procedure was initiated 2 minutes after the warm-up. The subjects were instructed to try to accomplish two repetitions with the imposed load in three attempts in both exercises. The rest period was 3 to 5 min between each attempt, and 5 min between exercises. The 1RM was recorded as the last resistance lifted in which the subject was able to complete only one single maximal execution
    Time Frame
    baseline and 12 weeks
    Title
    Dietary intake
    Description
    Participants were instructed by a dietitian to complete a food record on three nonconsecutive days (two week days and one weekend day) pre- and post-intervention. Participants were given specific instructions regarding the recording of portion sizes and quantities to identify all food and fluid intake, in addition to viewing food models in order to enhance precision. Total energy intake, protein, carbohydrate, and lipid content were calculated using nutrition analysis software (Avanutri Processor Nutrition Software, Rio de Janeiro, Brazil; Version 3.1.4). All participants were asked to maintain their normal diet throughout the investigation period.
    Time Frame
    baseline and 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement therapy, and not performing any regular physical exercise more than once a week in the six months preceding the beginning of the investigation. Participants passed a diagnostic graded exercise stress test with a 12-lead electrocardiogram, reviewed by a cardiologist, and were released with no restrictions for participation in this investigation. Exclusion Criteria: • All subjects not participating in 85% of the total sessions of training or withdrawl

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21694556
    Citation
    Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
    Results Reference
    background
    PubMed Identifier
    12145010
    Citation
    Kim J, Wang Z, Heymsfield SB, Baumgartner RN, Gallagher D. Total-body skeletal muscle mass: estimation by a new dual-energy X-ray absorptiometry method. Am J Clin Nutr. 2002 Aug;76(2):378-83. doi: 10.1093/ajcn/76.2.378.
    Results Reference
    background
    PubMed Identifier
    22309898
    Citation
    Stobaus N, Pirlich M, Valentini L, Schulzke JD, Norman K. Determinants of bioelectrical phase angle in disease. Br J Nutr. 2012 Apr;107(8):1217-20. doi: 10.1017/S0007114511004028. Epub 2011 Sep 28.
    Results Reference
    background
    PubMed Identifier
    9771855
    Citation
    Sardinha LB, Lohman TG, Teixeira PJ, Guedes DP, Going SB. Comparison of air displacement plethysmography with dual-energy X-ray absorptiometry and 3 field methods for estimating body composition in middle-aged men. Am J Clin Nutr. 1998 Oct;68(4):786-93. doi: 10.1093/ajcn/68.4.786.
    Results Reference
    background

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