Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001000594
Ethics application status
Approved
Date submitted
14/07/2015
Date registered
24/09/2015
Date last updated
24/09/2015
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 287080 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 295586 0
Obesity 295587 0
Condition category
Condition code
Inflammatory and Immune System 295861 295861 0 0
Other inflammatory or immune system disorders
Diet and Nutrition 295862 295862 0 0
Obesity
Metabolic and Endocrine 295863 295863 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 .
In S3, the Resistance Training was performed with the same exercises and sets from S1, however, with 3 sets of 6 repetitions at 6 RM (repetition maximum) and 1 minute and 30 seconds rest between sets. In the Aerobic Training, the same duration was maintained and an adjustment in the training zone and time duration (3 minutes at ventilatory threshold intensity, 12 minutes at ventilatory threshold and at less than respiratory compensation point intensity, 10 minutes at respiratory compensation point intensity, 5 minutes at ventilatory threshold intensity), with these intensities corresponding to 50–85% of VO2peak.
In all three stages of training, the total duration of the sessions was approximately 30-60 minutes. The frequency of sessions was 24 per stage, given three per week and a total of 72 sessions.
In all sessions, the subjects performed the resistance training or aerobic training or the resistance training following aerobic training protocol as his group. The resistance training was performed in a gym and the aerobic training in the athletic track, both located in the same place.
Aerobic training intensity for ventilatory threshold and respiratory compensation point was controlled by the velocity achieved during the respective physiologic points in the treadmill test, since it was performed on 1% grades to reproduce athletic track conditions. The treadmill test was performed at baseline and end of stages 1 and 2 to determine ventilatory threshold and respiratory compensation point for the upcoming stage. The treadmill test was conducted by Physical Education professional and consisted by a maximum-effort protocol, where running at maximal effort on a treadmill whilst wearing a face mask to measure respiratory gases, which were collected continuously using an automated breath-by-breath metabolic cart. The treadmill duration test varied from subject to subject.
Furthermore, the Resistance Training workloads were adjusted weekly. The subjects were encouraged to perform the greatest number of repetitions when they came to the last set of each exercise, maintaining the same range of motion and execution velocity previously determined. Workloads were increased by 1 kg for lower body and 1/2 kg for upper body for each repetition performed over the established training protocol, according to the greatest number of repetitions achieved by the participants in the previous week.
The subjects were recommended to not change their pre eating and physical activity habits during the program.
The training sessions was performed in group and was carried by Physical Education professional. The training adherence was monitored by log of session attendance.
Intervention code [1] 292317 0
Prevention
Intervention code [2] 292318 0
Treatment: Other
Intervention code [3] 292319 0
Lifestyle
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 295540 0
Biochemical Metabolic markers related to lipid and glucose homeostasis (composite primary outcome), assesssed by blood sample

Timepoint [1] 295540 0
baseline and at 2, 4 6 months after randomization
Primary outcome [2] 295541 0
Biochemical inflammatory markers (composite primary outcome) which are cytokines and adipokines assessed by blood sample.
Timepoint [2] 295541 0
baseline and at 2, 4 and 6 months after randomization
Primary outcome [3] 295542 0
body composition markers (composite primary outcome) assessed by skinfold and body circumferences
Timepoint [3] 295542 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [1] 315804 0
physical activity level using the IPAQ and Baecke Questionnaire
Timepoint [1] 315804 0
Baseline and at 2, 4 and 6 months after randomization
Secondary outcome [2] 315805 0
feeding behavior using food record in 3 days food recall
Timepoint [2] 315805 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [3] 315806 0
cardiorespiratory fitness using the treadmill incremental VO2 maximum test
Timepoint [3] 315806 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [4] 315807 0
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
Timepoint [4] 315807 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [5] 315808 0
Anthropometry using Body weight, height and waist circumference measurements
Timepoint [5] 315808 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [6] 315809 0
Abdominal fat using evaluation of skin folds and Ultrasound
Timepoint [6] 315809 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [7] 315810 0
Clinical metabolic markers (composite secondary outcome) composed by Lipid profile, glucose, and glycated hemoglobin serum concentrations using commercially available kits and Friedewald equation
Timepoint [7] 315810 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [8] 315811 0
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
Timepoint [8] 315811 0
baseline and at 6 months after randomisation
Secondary outcome [9] 315813 0
Insulin resistance and sensibility using Homeostasis Model Assessment index, QUICKI index, triglycerides/glucose index and Z score of metabolic syndrome (composite secondary outcome)
Timepoint [9] 315813 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [10] 315816 0
Type I of membrane protein fibronectin type III domain-containing protein 5 (FNDC5)/irisin levels using commercially available kits assessed by serum sample
Timepoint [10] 315816 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [11] 315817 0
Ghrelin using commercially available kits assessed by serum sample
Timepoint [11] 315817 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [12] 315818 0
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
Timepoint [12] 315818 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [13] 315819 0
Hormone profile and enzyme (Insulin, Testosterone, Cortisol, Growth hormone, insulin growth factor 1, lactate dehydrogenase) composite secondary outcome assessed by serum assay sample.
Timepoint [13] 315819 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [14] 315820 0
Myocardial circulation, assessed by myocardial echocardiography

Timepoint [14] 315820 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [15] 315822 0
Heart rate variability using commercial frequency meters
Timepoint [15] 315822 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [16] 315823 0
Blood pressure assessments using a mercury sphygmomanometer and stethoscope
Timepoint [16] 315823 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [17] 315824 0
Rest metabolic rate using indirect calorimetry at open circuit gas analysis system
Timepoint [17] 315824 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [18] 315825 0
Cardio and cerebro vascular index risk (Framingham risk score)
Timepoint [18] 315825 0
baseline and at 2, 4 and 6 months after randomization
Secondary outcome [19] 316608 0
Carotid artery structure, assessed by carotid ultrasound
Timepoint [19] 316608 0
baseline and at 2, 4 and 6 months after randomization

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sortition by research randomizer site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess the number of participants needed, the sample size calculation were performed based on previous study of our group and using G*Power3.1.9.2 software. To do it, we considered a power = 0.8, effect size = 0.40 and an alpha of 0.05, resulting in a target sample size of 80 participants. Data are presented in values of means +/- standard deviation (SD). The Student t-test was used to analyze differences between groups in the baseline and to identify the differences among percentages of changes. The mixed model was used to determine significant condition x time interactions. The Tukey post hoc test was applied to determine the source of significance, where a significant main effect and/or interaction was/were observed. The Pearson test was used to correlations analysis. The significance level for all these analyses was P < 0.05.The software packages used for all analyses were (SAS 9.2, SAS Institute Inc.,Cary, NC, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2012
Actual
5/03/2012
Date of last participant enrolment
Anticipated
13/12/2013
Actual
13/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
77
Recruitment outside Australia
Country [1] 7031 0
Brazil
State/province [1] 7031 0
Sao Paulo / Campinas

Funding & Sponsors
Funding source category [1] 291642 0
Government body
Name [1] 291642 0
Fundacao de Amparo a Pesquisa de Sao Paulo - FAPESP. "Foundation of the Sao Paulo Research"
Country [1] 291642 0
Brazil
Funding source category [2] 291643 0
Government body
Name [2] 291643 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico - CNPQ. "National Counsel of Technological and Scientific Development"
Country [2] 291643 0
Brazil
Primary sponsor type
Charities/Societies/Foundations
Name
Fundacao de Amparo a Pesquisa de Sao Paulo - FAPESP. "Foundation of the Sao Paulo Research"
Address
Rua Pio XI, 1500 - Alto da Lapa, Sao Paulo – SP, CEP: 05468-140 - Brazil
Country
Brazil
Secondary sponsor category [1] 290312 0
Government body
Name [1] 290312 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico - CNPQ. "National Counsel of Technological and Scientific Development"
Address [1] 290312 0
SHIS QI 1 Conjunto B - Blocos A, B, C e D

Lago Sul - Brasilia.DF - Cep: 71605-001
Country [1] 290312 0
Brazil
Other collaborator category [1] 278526 0
University
Name [1] 278526 0
University of Campinas
Address [1] 278526 0
Cidade Universitaria Zeferino Vaz - Barao Geraldo, Campinas - SP, 13083-970
Country [1] 278526 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293171 0
Research Ethics Committee at the State University of Campinas - UNICAMP
Ethics committee address [1] 293171 0
Ethics committee country [1] 293171 0
Brazil
Date submitted for ethics approval [1] 293171 0
07/12/2011
Approval date [1] 293171 0
08/02/2012
Ethics approval number [1] 293171 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 525 525 0 0
/AnzctrAttachments/368925-Approval Ethics Committee.docx

Contacts
Principal investigator
Name 58758 0
A/Prof Claudia Regina Cavaglieri
Address 58758 0
University of Campinas
Avenida Erico Verissimo, 701. University City "Zeferino Vaz" Barao Geraldo - Campinas – SP, CEP: 13083-851
Country 58758 0
Brazil
Phone 58758 0
+55 19 35216625 or +55 19 35216756
Fax 58758 0
Email 58758 0
[email protected]
Contact person for public queries
Name 58759 0
Ivan Luiz Padilha Bonfante
Address 58759 0
University of Campinas
Avenida Erico Verissimo, 701. University City "Zeferino Vaz" Barao Geraldo - Campinas – SP, CEP: 13083-851
Country 58759 0
Brazil
Phone 58759 0
+55 19 35216625 or +55 19 35216756
Fax 58759 0
Email 58759 0
[email protected]
Contact person for scientific queries
Name 58760 0
Ivan Luiz Padilha Bonfante
Address 58760 0
University of Campinas
Avenida Erico Verissimo, 701. University City "Zeferino Vaz" Barao Geraldo - Campinas – SP, CEP: 13083-851
Country 58760 0
Brazil
Phone 58760 0
+55 19 35216625 or +55 19 35216756
Fax 58760 0
Email 58760 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMetabolomics Approach in the Investigation of Metabolic Changes in Obese Men after 24 Weeks of Combined Training.2017https://dx.doi.org/10.1021/acs.jproteome.6b00967
EmbaseEffects of combined training on total ghrelin and tumor necrosis factor-alpha in obese middle-aged men.2018https://dx.doi.org/10.1590/S1980-6574201800020006
N.B. These documents automatically identified may not have been verified by the study sponsor.