Exercise training effects on biochemical, metabolic, physical fitness, body composition and hemodynamic markers

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001000594
• Date of registration: 24/09/2015
• Prospective Registration: No
• Primary sponsor: Fundacao de Amparo a Pesquisa de Sao Paulo - FAPESP. "Foundation of the Sao Paulo Research"
• Public title: Exercise training effects on biochemical, metabolic, physical fitness, body composition and hemodynamic markers
• Scientific title: Effects of aerobic training and resistance training on the levels of FNDC5/irisin, ghrelin, metabolic profile, insulin resistance, metabolic syndrome, inflammatory, hemodynamic, body composition and physical fitness markers in middle-aged overweight and obese men.
• Date of first enrolment: 05/03/2012
• Target sample size: 80
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001000594.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Brazil

Contacts

• Name: Prof Ivan Luiz Padilha Bonfante

• Name: Prof Ivan Luiz Padilha Bonfante

Key inclusion & exclusion criteria

Inclusion criteria: . Inactive middle-aged male subjects with body mass index (BMI) between 25 and 34.9 kg/m^2 were recruited through dissemination in the local media.
To be included in the study, subjects completed medical examination and were approved in effort electrocardiogram carried out by cardiologist. Participants had not been engaging in regular exercise programs during the previous 12 months and also were classified as physically inactive according to the IPAQ and Baecke Questionnaire. All participants provided their written informed consent prior entering the study.


Exclusion criteria: The exclusion criteria established for both groups were:
-Presence of acute illness, severe hypertension, diabetes mellitus, myocardial infarction and orthopedic limitations
-Use any medication that could interfere in the test results -Not be approved in effort electrocardiogram carried out by cardiologist.
-The participants must not change the eating habits and physical activity levels, other than the training sessions, for the study period.

Specifically the training subjects should participate in at least 85% of the training sessions and not miss more than two consecutive training sessions.


Age minimum: 40 Years
Age maximum: 60 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Obesity

Metabolic and Endocrine - Other metabolic disorders

Overweight ;Obesity;
Overweight
Obesity

Inflammatory and Immune System - Other inflammatory or immune system disorders

Intervention(s)

The training protocols were based on American College of Sports Medicine positions stands, and was composed of Aerobic Training and Resistance Training performed in the same session or in separated sessions, divided into three stages (S1, S2 and S3), each stage consisting of eight week, 3 per week, of training and was conducted one after the other for a total intervention duration of 24 weeks.
In S1, the subjects performed the Resistance Training through a linear periodization with six exercises (leg press, leg extension, leg curl, bench press, lateral pulldown and arm curl), with 3 sets of 10 repetitions at 10 RM (repetition maximum), and 1-min rest between sets. After this, participants were taken to an athletic track and performed 30 minutes of Aerobic Training by walking or running with varying intensity (5 minutes at less than ventilatory threshold intensity, 10 minutes at ventilatory threshold intensity, 10 minutes above ventilatory threshold and at less than respiratory compensation point intensity, 5 minutes at less than ventilatory threshold intensity), with these intensities corresponding to 50–85% of VO2peak.
In S2, the Resistance Training was performed with the same exercises and sets from S1, however, with 3 sets of 8 repetitions at 8 RM (repetition maximum) and 1 minute and 30 seconds rest between sets. In the Aerobic Training the same duration was maintained, however, there was an adjustment in the training zone and time duration (5 minutes at less than ventilatory threshold intensity, 10 minutes at ventilatory threshold and at less than respiratory compensationpoint intensity, 10 minutes at respiratory compensation point intensity, 5 minutes at less than ventilatory threshold intensity), with these intensities corresponding to 50–85% of VO2peak .

Primary Outcome(s)

Biochemical inflammatory markers (composite primary outcome) which are cytokines and adipokines assessed by blood sample.[baseline and at 2, 4 and 6 months after randomization]

Biochemical Metabolic markers related to lipid and glucose homeostasis (composite primary outcome), assesssed by blood sample

[baseline and at 2, 4 6 months after randomization]

body composition markers (composite primary outcome) assessed by skinfold and body circumferences[baseline and at 2, 4 and 6 months after randomization]

Secondary Outcome(s)

cardiorespiratory fitness using the treadmill incremental VO2 maximum test[baseline and at 2, 4 and 6 months after randomization]

Type I of membrane protein fibronectin type III domain-containing protein 5 (FNDC5)/irisin levels using commercially available kits assessed by serum sample[baseline and at 2, 4 and 6 months after randomization]

Carotid artery structure, assessed by carotid ultrasound [baseline and at 2, 4 and 6 months after randomization]

Heart rate variability using commercial frequency meters[baseline and at 2, 4 and 6 months after randomization]

Hormone profile and enzyme (Insulin, Testosterone, Cortisol, Growth hormone, insulin growth factor 1, lactate dehydrogenase) composite secondary outcome assessed by serum assay sample.[baseline and at 2, 4 and 6 months after randomization]

Myocardial circulation, assessed by myocardial echocardiography

[baseline and at 2, 4 and 6 months after randomization]

Maximal-strength assessed in quadriceps muscle, pectoral muscle and arm biceps muscle using respectivement one repetition maximum test by leg press, bench press and barbell exercises[baseline and at 2, 4 and 6 months after randomization]

Abdominal fat using evaluation of skin folds and Ultrasound[baseline and at 2, 4 and 6 months after randomization]

Ghrelin using commercially available kits assessed by serum sample[baseline and at 2, 4 and 6 months after randomization]

Insulin resistance and sensibility using Homeostasis Model Assessment index, QUICKI index, triglycerides/glucose index and Z score of metabolic syndrome (composite secondary outcome)[baseline and at 2, 4 and 6 months after randomization]

Anthropometry using Body weight, height and waist circumference measurements[baseline and at 2, 4 and 6 months after randomization]

Inflammatory markers (Interleukin 6, interleukin 10, interleukin 15, C- reactive protein, prostaglandine E 2, tumor necrosis factor alpha, Leptin, Resistin, Adiponectin, lipopolysaccharide) assessed by commercially available kits for Enzyme-Linked Immunosorbent Assay using serum sample[baseline and at 2, 4 and 6 months after randomization]

Blood pressure assessments using a mercury sphygmomanometer and stethoscope[baseline and at 2, 4 and 6 months after randomization]

Cardio and cerebro vascular index risk (Framingham risk score)
[baseline and at 2, 4 and 6 months after randomization]

Metabolic profile and biomarkers using nuclear magnetic ressonance (metabolomic). Composite secondary outcome assessed by serum sample analyzed by nuclear magnetic ressonance, which determine the metabolic present in the sample. This method detects around one hundred metabolics,
but this number depends on the physiological individuality of each subject [baseline and at 6 months after randomisation]

feeding behavior using food record in 3 days food recall[baseline and at 2, 4 and 6 months after randomization]

physical activity level using the IPAQ and Baecke Questionnaire [Baseline and at 2, 4 and 6 months after randomization]

Rest metabolic rate using indirect calorimetry at open circuit gas analysis system[baseline and at 2, 4 and 6 months after randomization]

Clinical metabolic markers (composite secondary outcome) composed by Lipid profile, glucose, and glycated hemoglobin serum concentrations using commercially available kits and Friedewald equation[baseline and at 2, 4 and 6 months after randomization]

Secondary ID(s)

None

Source(s) of Monetary Support

Conselho Nacional de Desenvolvimento Cientifico e Tecnologico - CNPQ. "National Counsel of Technological and Scientific Development"

Fundacao de Amparo a Pesquisa de Sao Paulo - FAPESP. "Foundation of the Sao Paulo Research"

Secondary Sponsor(s)

Conselho Nacional de Desenvolvimento Cientifico e Tecnologico - CNPQ. "National Counsel of Technological and Scientific Development"

Ethics review

Status: Approved
Approval date:
Contact:

Research Ethics Committee at the State University of Campinas - UNICAMP