Clinical trial NCT02918448: Resistance Training and Metabolic Syndrome
Official title: A Resistance Training Program Decreases the Risk of Metabolic Syndrome and Inflammatory Biomarkers in Older Adult Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 53
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Detailed description: 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. For the selection of the sample all participants completed a health history and we adopted 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 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. Written informed consent was obtained from all participants after being provided with a detailed description of investigation procedures. This investigation was conducted according to the Declaration of Helsinki and approved by the local University Ethics Committee. 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. It was also evaluated the Z-score risk for metabolic syndrome, which was based on the risk factors for metabolic syndrome. A supervised progressive RT program was performed between weeks 4-15 by the training group. The CG did not perform any type of physical exercise during this period. The RT training program was based on recommendations for RT in an older population. 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. Instructors adjusted the loads of each exercise according to the subject's ability and improvements in exercise capacity throughout the investigation in order to ensure that the subjects were exercising with as much resistance as possible while maintaining proper exercise technique.

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

Primary outcomes:
measure: Change in Inflammatory Biomarkes
timeFrame: Baseline and 12 weeks
measure: Change in Lipid and Glycemic Profiles
timeFrame: Baseline and 12 weeks
measure: Change in Homeostasis Model Assessment (HOMA-IR)
timeFrame: Baseline and 12 weeks
measure: Change in Blood Pressure
timeFrame: Baseline and 12 weeks
measure: Change in Metabolic Syndrome Z score
timeFrame: Baseline and 12 weeks
measure: Change in C-reative Protein
timeFrame: Baseline and 12 weeks
measure: Change in Body Composition
timeFrame: Baseline and 12 weeks
measure: Change in Waist Circumference
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Changes in Anthropometry Parameters
timeFrame: Baseline and 12 weeks
measure: Changes in Total Strength
timeFrame: Baseline and 12 weeks
measure: Changes in Dietary intake
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
citation: 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.
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.