Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001394730
Ethics application status
Approved
Date submitted
13/09/2022
Date registered
31/10/2022
Date last updated
31/10/2022
Date data sharing statement initially provided
31/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a health training intervention on body composition and level of selected adipokines of adipose tissue in males with metabolic syndrome
Scientific title
Effect of a twelve-week health training intervention on body composition and level of selected adipokines of adipose tissue in males with metabolic syndrome
Secondary ID [1] 308098 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome 323744 0
overweight 323745 0
obesity 323746 0
hypercholesterolaemia 323747 0
diabetes 323748 0
Condition category
Condition code
Metabolic and Endocrine 321272 321272 0 0
Metabolic disorders
Metabolic and Endocrine 324863 324863 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the project is to assess an influence of two types of twelve-week health training interventions (training of an aerobic character vs. aerobic-resistance training) on body mass, the level of selected adipokines and features of the metabolic syndrome in males with metabolic syndrome in relation to males with metabolic syndrome who did not participate in the training (a control group). The examined from all three groups will then be observed for four weeks - a follow-up.
The health training interventions will take place in a Fitness Club in Cracow under supervision of a personal coach. Before the beginning of examinations, the level of aerobic and anaerobic capacity will be determined with the use of proper tests and the level of physical activity will be assessed. Planning and monitoring the intensity in the aerobic training as well as amount of load in the resistance training will be set individually based on guidelines of the American College of Sports Medicine (1995). Intensity of the training will be monitored through pulse with the system of Polar M200 GPS Running Watch with Wrist-Based Heart Monitor. Whereas, before the resistance training, the participants will take the test of one-rep max (1RM) which is considered to be a gold standard for assessment of muscles force in non-laboratory situations. Planned course of aerobic training: trainings will take place 3 times per week in groups of no more than 5, will start with a 5-min warm-up, reaching intensity of 50% maximum heart rate (HR max). After warm-up, the participants will increase intensity to 70% HR max. It will base on increasing velocity or angle for a treadmill, resistance for upright or recumbent bikes and range of movement or resistance for an x-trainer. Duration of the training will be 45 min. After the training, the participants will stretch the muscles groups engaged in the training (10 min).
Planned course of the aerobic-resistance training:
The health training with elements of aerobic-resistance exercises will take place 3 times per week, in groups no more than 5. The training will start with a 5-min aerobic warm-up (walking on a treadmill to reach an intensity of 50% HR max). Initially it will comprise 3 complex exercises, such as sit-ups, regular or supported, push-ups with adjustable height of arm prop, bent isolated one-arm dumbbell row, 4 series. Following the adaptation of the body to the training, the intensity will include 3 series of 9 exercises, with 60-sec breaks between them. At first the loads will be set at 50% of 1RM, after 4 weeks it will rise to 70%. After resistance exercises, the participants will train on an exercise bike, x-trainer or treadmill at intensity of 70% HR max. The duration of resistance training during each session will be 25 minutes, followed by 20 minutes of aerobic training. Training will finish with stretching the engaged muscles groups (10 min). The duration of the whole training will be 60 min. It will engage large muscles groups, whereas in subsequent exercises, through isolation of the practised exercises position, the synergistic muscles of lower mass will be activated. The training will employ dumbbells, barbells, training devices, own body mass.
All of the trainings will be carried out at the same time of day (in the afternoon) by the same, qualified a personal coach (with minimum 5 years' experience), in a room with the same temperature and humidity. Each volunteer will be qualified by a physician before participation in the study. The session attendance checklists will be used to monitor adherence to the intervention. The therapy will take place at Fitness Club in Cracow, Poland and will be supervised by the members of the University of Physical Education in Krakow, Poland.
Intervention code [1] 321800 0
Treatment: Other
Intervention code [2] 321801 0
Rehabilitation
Comparator / control treatment
A group without health trainings: the participants in the control group will not receive any treatments during this study and will be asked not to alter their nutritional habits, taken medicines, or level of physical activity during the experiment.
Control group
Active

Outcomes
Primary outcome [1] 329053 0
Influence of treatment on the body composition (fat free mass (FFM) (kg), body fat mass (BF) (kg), percentage of body fat (BF) (%), android body fat (AND)(%), gynoid body fat (GYN) (%), body mass index (BMI) (kg/m2), body mineral density (BMD) (g/cm2)) assessed by the Dual X-ray Absorptiometry (DXA) method.
Timepoint [1] 329053 0
Baseline, 6 weeks post-intervention commencement, 12 weeks post-intervention commencement (primary endpoint), 4 weeks post-intervention completion
Primary outcome [2] 332537 0
Influence of treatment on the levels of human hormones (leptin (ng/ml), asprosin (ng/ml), irisin (ng/ml), adiponectin (ng/ml), omentin (ng/ml), IL-6 (ng/ml) and IL-8 (ng/ml)) assessed in blood sample using ELISA kits according to the manufacturer's protocol by spectrophotometric microplate reader.
Timepoint [2] 332537 0
Baseline, 6 weeks post-intervention commencement, 12 weeks post-intervention commencement (primary endpoint), 4 weeks post-intervention completion
Primary outcome [3] 332538 0
Influence of treatment on the levels of indicators of carbohydrate-lipid metabolism (glucose (mmol/L) - enzymatic method, insulin (µIU/mL) - electrochemiluminescence method, total cholesterol (mmol/L), low-density lipoprotein cholesterol (mmol/L), high-density lipoprotein cholesterol (mmol/L), non-HDL cholesterol (mmol/L), triglycerides (mmol/L) - spectrophotometric method, C-reactive protein (hsCRP) (mg/dl) - immunoturbidimetric method assessed in blood sample.
Timepoint [3] 332538 0
Baseline, 6 weeks post-intervention commencement, 12 weeks post-intervention commencement (primary endpoint), 4 weeks post-intervention completion
Secondary outcome [1] 401280 0
Effects of treatment on the levels of average daily energy expenditures over the previous 7 days assessed by the Metabolic Equivalent of a Task (MET) formula [MET min/week] expressed as value of intensity x duration per day x frequency per week as primary outcome.
Timepoint [1] 401280 0
Baseline, 6 weeks post-intervention commencement, 12 weeks post-intervention commencement, 4 weeks post-intervention completion as primary timepoint.
Secondary outcome [2] 413852 0
Effects of treatment on the level of dietary caloric intake assessed as kcal/day as primary outcome. A qualified dietician will carry out a 24-hour dietary recall (24HR) with the method of nutrition record to quantitatively assess nutrition habits. The result will be introduced to the DietaPro program (Institute of Food and Nutrition, Warsaw, Poland).
Timepoint [2] 413852 0
Baseline, 6 weeks post-intervention commencement, 12 weeks post-intervention commencement, 4 weeks post-intervention completion as primary timepoint

Eligibility
Key inclusion criteria
male sex, age 30-45 years, medical statement on lack of contraindications to take up health training of aerobic-resistance character, written consent for voluntary participation in the research project, increased waist circumference greater than or equal to 94 cm and two criteria out of the following: concentration of triglycerides greater than 150 mg/dl (1.7 mmol/l) or treated hyper-triglyceridemia; concentration of HDL C less than 40 mg/dl (1.03 mmol/l) – in males or treating the lipid disorder; blood pressure systolic (SBP) greater than or equal to 130 mm Hg or diastolic (DBP) greater than or equal to 85 mm Hg, or treatment of a formerly diagnosed hypertension; glucose level in plasma on empty stomach greater than or equal to 100 mg/dl (5.6 mmol/) or pharmacological treatment of type 2 diabetes (T2DM).
Minimum age
30 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
no medical statement on lack of contraindications to take up health training of aerobic-resistance character, unwillingness to continue the intervention (lack of more than 10% of training sessions), unstable ischaemia, decompensated heart failure, uncontrolled heart rhythm disorders, severe pulmonary hypertension (mean blood pressure in lungs > 55 mm Hg), symptomatic aortic stenosis, acute myocarditis, endocarditis or pericarditis, uncontrolled blood pressure (> 180/110 mm Hg), aortic dissection, Marfan syndrome, uncontrolled diabetes, mental disorders, health problems (orthopaedic, neurologic) preventing movement, participation in another form of physical activity during the project, lack of written consent to take part in the examination.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
The distribution of results for the analyzed variables will be checked by applying a
Shapiro–Wilk test. For single measurements, the significance of group-related differences
will be assessed using independent-sample tests, Student’s t-test or the Kruskal-Wallis
test. In the examined and control groups for comparing the impact of intervention on changes in the analyzed variables analysis of variance with repeated measures will be used for variables of normal distribution and Friedman test for variables of skewed distribution with post hoc comparison. The statistical significance of differences
was assumed for a level of p < 0.05. The STATISTICA 13 package (StatSoft, Inc., Tulsa, OK,
USA) was used for calculations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/09/2020
Date of last participant enrolment
Anticipated
Actual
15/01/2021
Date of last data collection
Anticipated
Actual
15/06/2021
Sample size
Target
60
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 24144 0
Poland
State/province [1] 24144 0

Funding & Sponsors
Funding source category [1] 309755 0
University
Name [1] 309755 0
University of Physical Education in Kraków, Poland
Country [1] 309755 0
Poland
Primary sponsor type
Individual
Name
prof. Agnieszka Suder
Address
Faculty of Physical Rehabilitation
Institute of Basic Science
Department of Anatomy
al. Jana Pawla II 78
30-245 Kraków
Country
Poland
Secondary sponsor category [1] 310779 0
Individual
Name [1] 310779 0
mgr Karol Makiel
Address [1] 310779 0
Faculty of Physical Rehabilitation
Institute of Basic Science
Department of Anatomy
al. Jana Pawla II 78
30-245 Kraków
Country [1] 310779 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309510 0
The Ethical Commitee of Regional Medical Chamber in Krakow
Ethics committee address [1] 309510 0
Ethics committee country [1] 309510 0
Poland
Date submitted for ethics approval [1] 309510 0
06/04/2020
Approval date [1] 309510 0
05/06/2020
Ethics approval number [1] 309510 0
90/KBL/OIL/2020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114410 0
Prof Agnieszka Suder
Address 114410 0
Faculty of Physical Rehabilitation
Institute of Basic Science
Department of Anatomy
al. Jana Pawla II 78
30-245 Kraków
Country 114410 0
Poland
Phone 114410 0
+48126831329
Fax 114410 0
Email 114410 0
[email protected]
Contact person for public queries
Name 114411 0
Karol Makiel
Address 114411 0
Faculty of Physical Rehabilitation
Institute of Basic Science
Department of Anatomy
al. Jana Pawla II 78
30-245 Kraków
Country 114411 0
Poland
Phone 114411 0
+48126831159
Fax 114411 0
Email 114411 0
[email protected]
Contact person for scientific queries
Name 114412 0
Agnieszka Suder
Address 114412 0
Faculty of Physical Rehabilitation
Institute of Basic Science
Department of Anatomy
al. Jana Pawla II 78
30-245 Kraków
Country 114412 0
Poland
Phone 114412 0
+48126831159
Fax 114412 0
Email 114412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseEffect of Exercise Interventions on Irisin and Interleukin-6 Concentrations and Indicators of Carbohydrate Metabolism in Males with Metabolic Syndrome.2023https://dx.doi.org/10.3390/jcm12010369
EmbaseImpact of Two Types of Exercise Interventions on Leptin and Omentin Concentrations and Indicators of Lipid and Carbohydrate Metabolism in Males with Metabolic Syndrome.2023https://dx.doi.org/10.3390/jcm12082822
N.B. These documents automatically identified may not have been verified by the study sponsor.