Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000874718
Ethics application status
Approved
Date submitted
2/08/2013
Date registered
6/08/2013
Date last updated
7/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of 8 weeks of aerobic or modified football training on skeletal muscle markers of mitochondrial functioning, systemic inflammation and glucose regulation
Scientific title
Effects of 8 weeks of aerobic or modified football training on mitochondrial biogenesis, systemic inflammation and glucose regulation within sedentary, middle-aged men.
Secondary ID [1] 282954 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes mellitus 289779 0
cardiovascular disease 289798 0
Condition category
Condition code
Metabolic and Endocrine 290127 290127 0 0
Diabetes
Cardiovascular 290156 290156 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical Activity and Nutritional Documentation
All participants will be provided with an exercise diary for the documentation of physical activity external to the study. Additionally, an exercise log will be kept by the Chief Investigator, which will consist of exercise information pertaining to the actual work completed during training sessions. Participants will also be informed of the importance of maintaining normal diet and nutritional patterns including macro- and micro-nutrient consumption (contribution from CHO, fat, protein; vitamin/mineral supplementation), time of consumption (lateness of evening meal), quantity of serving (dietary caloric restriction), type of preparation (cooking oils used, boil/steam/raw, etc), and alcohol consumption (type and quantity).

The cycling and modified football training programs will consist of 4 mesocycles (blocks) of 2 weeks, with session duration and intensity steadily progressing from one mesocycle to the next. This protocol will allow for appropriate training adaptations to occur prior to an increase in intensity, thus allowing all participants to complete all exercise sessions in a comfortable manner.

Aerobic (cycling) Training Program
The aerobic exercise program will involve participants performing continuous a cycling exercise on a stationary ergometer for a total of 3 sessions per week. Each session will be monitored by an exercise physiologist. During the 8 weeks, exercise duration will increase from 30 to 45 min, and intensity will be increase from 70 to 80% of maximal heart rate. In each training session pedalling resistance, rpm and heart rate will be recorded at 5 minute intervals and at the conclusion an overall RPE will be obtained.

Modified Football Training Program
The modified football program will involve participants exercising for 3 sessions per week of touch football games. Each session will be monitored by an exercise physiologist. Additionally, during one training session per week GPS units will be utilised to identify any improvements in velocity and total distance covered throughout the exercise program. During the 8 weeks, total session duration will increase from 30 to 45 min, and total game play (intensity) will increase from 22 to 38 minutes. In each training session heart rate will be recorded during the rest intervals and at the conclusion an overall RPE will be obtained.
Intervention code [1] 287662 0
Prevention
Intervention code [2] 287679 0
Lifestyle
Comparator / control treatment
Control Intervention - No intervention
The control condition will involve participants continuing their sedentary life and normal dietary and nutritional patterns for the 8 week intervention period. Participants will be provided with a dietary journal and a physical activity journal in which they will be required to document any dietary changes or physical activity which will include walking, strenuous manual labour, strenuous gardening, etc., respectively. Participants will receive both verbal and written instruction expressing the importance of maintaining these patterns, and the journals will be reviewed by the study investigators to ensure conformity with the control condition. Following the 8 week intervention period, participants within the control group will be invited to attend the CSU gymnasium to commence a specifically tailored exercise training program.
Control group
Active

Outcomes
Primary outcome [1] 290156 0
Body composition
(Body mass, height, waist and hip girth measures will be measured to calculate BMI (mass [kg]/ height [m2]), waist to hip ratio (WHR) and a body composition scan (DXA) for the determination of abdominal adiposity, total body fat mass and total body lean mass)
Timepoint [1] 290156 0
Pre- and post 8 week intervention
Primary outcome [2] 290174 0
Blood collection
An OGTT will be administered with venous samples collected at the 30, 60, 90 and 120 min for the analysis of insulin, glucose and C-peptide. Fasting CRP, blood glucose, insulin, HbA1c, total lipid profile (total cholesterol, LDL, HDL, Triglycerides), TNF-alpha, IL-6, Il-1 beta and IL-1ra.
Timepoint [2] 290174 0
Pre- and post 8 week intervention
Primary outcome [3] 290175 0
Muscle Biopsy Collection and Analysis
Vastus lateralis muscle. A local anaesthetic (Xylocaine 1%) will be administered and a 5mm Bergstrom Biopsy needle will be used to excise a ~80mg piece of muscle. Muscle analysis will be used to measure total protein content associated with mitochondrial biogenesis and glucose regulation (SIRT1, PGC-1alpha, p53, GLUT 4, AKT, MEF2A, Tfam, NRF1, NRF2, OXPHOS complex I-V)
Timepoint [3] 290175 0
Pre- and post 8 week intervention
Secondary outcome [1] 304029 0
Sub-Maximal Aerobic Capacity Testing
Subjects will perform a sub-maximal graded exercise test (GXT) on an electronically braked cycle ergometer (LODE Excalibur Sport, LODE BV, Groningen, The Netherlands) to determine oxygen consumption and maximal aerobic power output. The test will incorporate an incremental step protocol consisting of 1 min stages for each step of the protocol, commencing at 25 W with increments of 25 W each minute. Heart rate (Vantage NV, Polar, Finland) will be recorded each minute throughout the protocol, and subjects exercised until volitional exhaustion or upon attainment of 80% age-predicted maximal heart rate (MHR).
Timepoint [1] 304029 0
Pre- and post 8 week intervention
Secondary outcome [2] 304056 0
Sub-Maximal Strength Testing
Subjects will complete a 3RM strength test. The 3RM testing procedure will identify upper-body and lower-body strength of seated chest press and leg press (Panatta Sport, Apiro, Italy), respectively. Subjects will attempt ascending resistances, separated by a 2 min recovery period until the determination of upper- and lower-body 3RM.
Timepoint [2] 304056 0
Pre- and post 8 week intervention

Eligibility
Key inclusion criteria
Subject Population
The study population will comprise of 36 sedentary, Caucasian male subjects aged 35-60 y, who are in a non-diseased state. All testing procedures and training programs will be conducted at the CSU laboratory and subjects will be recruited from regional Bathurst areas. All subjects will be randomized into exercise protocols including an aerobic, modified football, or control protocol, allowing 12-15 subjects in each protocol to complete the allocated training intervention.
Minimum age
35 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subject recruitment will ensure a non-smoking sample population group representative of a sedentary lifestyle, but not clinically diagnosed with any pre-existing CVD or metabolic disorders. Participants with orthopaedic limitations will also be advised against study involvement due to the musculoskeletal demands of the respective exercise protocols.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Parallel
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data are reported as mean +/- SEM. A repeated-measures (condition x time) ANOVA was used to determine significant differences between the respective groups. A one-way ANOVA was used where significant main effect and/or interaction was observed, of pre-intervention to post-intervention differences (absolute values). Significance was accepted at P<0.05. All data not normally distributed was log transformed prior to analysis. All statistical analyses were performed using PASW trademark for MS-Windows version 20.0 (Statistical Package for the Social Sciences, Chicago, IL, USA).
Sample size calculations using G-Power software indicated that a minimum of 8 participants per condition for all primary and secondary outcomes is required to ensure no type 1 or type 2 statisical errors are made within data interpretation

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/09/2011
Date of last participant enrolment
Anticipated
7/10/2011
Actual
7/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7250 0
2795 - Bathurst

Funding & Sponsors
Funding source category [1] 287730 0
University
Name [1] 287730 0
charles Sturt University
Country [1] 287730 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
N1 Allen house
Panorama Avenue,
Bathurst, NSW, 2795
Country
Australia
Secondary sponsor category [1] 286458 0
None
Name [1] 286458 0
none
Address [1] 286458 0
none
Country [1] 286458 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289686 0
Charles Sturt University, Human Ethics Research Committee
Ethics committee address [1] 289686 0
Ethics committee country [1] 289686 0
Australia
Date submitted for ethics approval [1] 289686 0
Approval date [1] 289686 0
29/09/2011
Ethics approval number [1] 289686 0
2011/113

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

Contacts
Principal investigator
Name 41958 0
Miss Amy Mendham
Address 41958 0
Charles Sturt University
School of Human Movement Studies

N1 Allen house
Panorama Avenue,
Bathurst, NSW, 2795
Country 41958 0
Australia
Phone 41958 0
+61478 725 224
Fax 41958 0
Email 41958 0
[email protected]
Contact person for public queries
Name 41959 0
Amy Mendham
Address 41959 0
Charles Sturt University
School of Human Movement Studies

N1 Allen house
Panorama Avenue,
Bathurst, NSW, 2795
Country 41959 0
Australia
Phone 41959 0
+61478 725 224
Fax 41959 0
Email 41959 0
[email protected]
Contact person for scientific queries
Name 41960 0
Amy Mendham
Address 41960 0
Charles Sturt University
School of Human Movement Studies

N1 Allen house
Panorama Avenue,
Bathurst, NSW, 2795
Country 41960 0
Australia
Phone 41960 0
+61478 725 224
Fax 41960 0
Email 41960 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
EmbaseRugby-specific small-sided games training is an effective alternative to stationary cycling at reducing clinical risk factors associated with the development of type 2 diabetes: A randomized, controlled trial.2015https://dx.doi.org/10.1371/journal.pone.0127548
N.B. These documents automatically identified may not have been verified by the study sponsor.