NCT02940145

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

October 17, 2016

Last Update Submit

June 19, 2017

Conditions

Keywords

inflammatory biomarkersInterleukinesresistance trainingphase angleoxidative stress

Outcome Measures

Primary Outcomes (8)

  • 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

    baseline and 12 weeks

  • 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.

    baseline and 12 weeks

  • 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).

    baseline and 12 weeks

  • 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)

    baseline and 12 weeks

  • 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).

    Baseline and 12 weeks

  • 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 .

    Baseline and 12 weeks

  • 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)

    Baseline and 12 weeks

  • 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.

    Baseline and 12 weeks

Secondary Outcomes (2)

  • change in Muscular strength

    baseline and 12 weeks

  • Dietary intake

    baseline and 12 weeks

Study Arms (2)

intervention 1

EXPERIMENTAL

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

Other: Resistance Training

control group

NO INTERVENTION

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

Interventions

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.

intervention 1

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 21694556BACKGROUND
  • 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.

    PMID: 12145010BACKGROUND
  • 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.

    PMID: 22309898BACKGROUND
  • 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.

    PMID: 9771855BACKGROUND

MeSH Terms

Conditions

Glucocorticoid Receptor Deficiency

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 20, 2016

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

November 1, 2015

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share