Resistance Training and Metabolic Syndrome

NCT02918448 | Completed Phase 2

• 1 other identifier: UEL10656/2012
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

Metabolic syndrome (MetS) is a multicomponent disorder closely linked to low grade inflammation, and cardiovascular disease (CVD). The aim of this study was to investigate the effects of a 12-week resistance training (RT) program on body composition, risk factors for metabolic syndrome (MetS), and inflammatory biomarkers in older adult women

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (8)

• Change in Inflammatory Biomarkes

  Measurements of TNF-α, and IL-6, 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). The results are presented in picograms per milliliter (pg/ml). All samples were determined in duplicate to guarantee the precision of the results.

  Baseline and 12 weeks

• Change in Lipid and Glycemic Profiles

  Venous blood samples were collected after a 12 h fast and a minimum of 72 h after the final physical exercise session. Five milliliters were withdrawn from a prominent superficial vein in the antecubital space using a clean venous puncture with minimal stasis and placed in a tube containing ethylenediaminetetraacetic acid (EDTA) as an anticoagulant and conservant and a tube without coagulant. All samples were centrifuged for 15 min, and plasma or serum aliquots were stored at -80ºC until assayed. Measurements of glucose, high-density lipoprotein (HDL-C), and triglycerides (TG), were immediately determined in a specialized laboratory at University Hospital. The analyses 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 deciliter (mg/dL)

  Baseline and 12 weeks

• Change in Homeostasis Model Assessment (HOMA-IR)

  Insulin was measured by chemiluminescence using a Liaison XL analyzer (DiaSorin S.p.A., Saluggia, Italy). The homeostasis model assessment (HOMA-IR) was calculated by the formula: fasting insulin (μUI/ml) x fasting glucose (mmol/L)/22.5. Inter- and intra-assay coefficients of variation were \<10% as determined in human plasma.

  Baseline and 12 weeks

• Change in Blood Pressure

  Resting BP assessment was performed using automatic oscillometric equipment (Omron HEM-742INT model, Omron Corporation, Kyoto, Kansai, Japan). Participants attended the laboratory on three different days and, during each visit, remained seated at rest for five minutes with the cuff of the equipment in place on the right arm. Subsequently, several BP measurements were performed at one-minute intervals in order to obtain three consecutive measurements where the difference in Systolic BP (SBP) and Diastolic BP (DBP) readings differed by no more than 4 mmHg. The median of the three measurements for each day was averaged across the three visits. Mean arterial pressure (MAP) was calculated using the formula MAP= DBP + 1/3 (SBP-DBP). The results are presented in (mmHg)

  Baseline and 12 weeks

• Change in Metabolic Syndrome Z score

  The metabolic syndrome Z score was also used in the present investigation as a continuous score of the five metabolic syndrome variables in agreement with the Adult Treatment Panel III criteria. A Z score was calculated for each variable using individual data, and standard deviations of data for the entire group at baseline (n = 53) and post intervention (n =47). The equation used to calculate the metabolic syndrome Z-score was Z score pre intervention = \[(50 - HDL)/11.1 (11.9m2) + (TG - 150)/36.8 (42.1)\] + \[(fasting blood glucose - 100)/14.8 (13.7 m2)\] + \[(waist circumference - 88)/9.4 (9.9 m2)\] + \[(mean arterial pressure - 100)/6.4 (7.7) m2\], and Z score post intervention= \[(50 - HDL)/11.9 + (TG - 150)/42.1)\] + \[(fasting blood glucose - 100)/13.7)\] + \[(waist circumference - 88)/9.9\] + \[(mean arterial pressure - 100)/7.7)\].

  Baseline and 12 weeks

• Change in C-reative Protein

  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 milligram/liter (mg/L)

  Baseline and 12 weeks

• Change in Body Composition

  Whole-body dual-energy X-ray absorptiometry (DXA) scans (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) were used to assess body fat, trunk fat and appendicular lean soft tissue. The total skeletal muscle mass was estimated by the predictive equation proposed by Kim et al.. Prior to scanning, participants were instructed to remove all objects containing metal. Scans were performed with the subjects lying in the supine position along the table's longitudinal centerline axis. Feet were taped together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. Both calibration and analysis were carried out by a skilled laboratory technician. Equipment calibration followed the manufacturer's recommendations. The software generated standard lines that set apart the limbs from the trunk and head. These lines were adjusted by the same technician using specific anatomical points determined by the manufacturer.

  Baseline and 12 weeks

• Change in Waist Circumference

  Measures of waist circumference (WC) were obtained according to procedures established in the literature. The results are presented in centimeters (cm).

  Baseline and 12 weeks

Secondary Outcomes (3)

• Changes in Anthropometry Parameters

  Baseline and 12 weeks

• Changes in Total Strength

  Baseline and 12 weeks

• Changes in Dietary intake

  Baseline and 12 weeks

Study Arms (2)

Taining group

EXPERIMENTAL

training group that performed the resistance 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. The RT program was performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl (free weights), leg curl, triceps pushdown, and seated calf raise. Participants of the TG performed 3 sets of 10-15 repetition maximums. 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: Training group

control group

NO INTERVENTION

control group that did not perform any type of physical exercise

Interventions

Training group OTHER

The investigation was carried out over a period of 18 weeks, with 12 weeks dedicated to the RT program and 6 weeks allocated for measurements. Anthropometric, one repetition maximum tests (1RM), body composition, blood pressure (BP), dietary intake and blood sample measurements were performed in weeks 1-3, and 16-18. A supervised progressive RT program was performed between weeks 4-15 by the training group.

Taining group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

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: 21694556 RESULT

• Conceicao MS, Bonganha V, Vechin FC, Berton RP, Lixandrao ME, Nogueira FR, de Souza GV, Chacon-Mikahil MP, Libardi CA. Sixteen weeks of resistance training can decrease the risk of metabolic syndrome in healthy postmenopausal women. Clin Interv Aging. 2013;8:1221-8. doi: 10.2147/CIA.S44245. Epub 2013 Sep 16.

  PMID: 24072967 RESULT

• Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.

  PMID: 16157765 RESULT

• 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: 12145010 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 21, 2016
• First Posted: September 29, 2016
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share