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Trial registered on ANZCTR


Registration number
ACTRN12618000148279p
Ethics application status
Submitted, not yet approved
Date submitted
15/01/2018
Date registered
31/01/2018
Date last updated
31/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of ‘Recreational Marathon Training’ versus ‘Interval Training’ on Exercise Adherence and Cardiometabolic Health in Apparently Healthy Adults
Scientific title
The Effect of ‘Recreational Marathon Training’ versus ‘Interval Training’ on Exercise Adherence and Cardiometabolic Health in Apparently Healthy Adults
Secondary ID [1] 293786 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 306180 0
metabolic syndrome 306181 0
Condition category
Condition code
Cardiovascular 305294 305294 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 305295 305295 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will consist of two phases. The first phase will require the participants to attend three supervised training sessions per week for 32 weeks. Participants will then enter the second phase of the trial and will continue with the same exercise program from Phase 1, but in an unsupervised manner until the 52-week follow-up. The participants will be tested at baseline and after 16 weeks, 32 weeks, and 52 weeks follow-up. Written informed consent will be obtained from all participants before inclusion. All participants will receive verbal and written information about their exercise training intervention.

The study will consist of 2 intervention groups; 1) marathon training and 2) interval training. All supervised exercise sessions during Phase 1 will be supervised by a qualified exercise professional at His&HerTime Fitness Club, with over 11 years of experience conducting similar exercise programs. Phase 2 will be performed in an unsupervised environment. Exercise heart rate (HR), RPE, volume (distance/week and hours/week) during both Phases will be monitored and recorded. HR and RPE will be monitored via a HR monitor (Polar Electro, Kempele, Finland) and the Borg 6-20 RPE scale, respectively. A training log will be provided to all participants to record HR and RPE attained during the unsupervised sessions.

Marathon Training
The participants in the marathon training group will be required to exercise for an hour per session (including rest periods between exercise types within the circuit based training) at 85-95% peak heart rate (HRpeak) or RPE of 15-17, three times per week (with at least a day between sessions) for 52 weeks. Supervised exercise sessions will consist of a mix of circuit based training (ie fitness and light weight training) and a jogging program.
Intervention code [1] 300038 0
Behaviour
Intervention code [2] 300039 0
Prevention
Comparator / control treatment
Interval training
The interval training protocol will consist of 4-min high-intensity exercise bout at 85-95% HRpeak or RPE of 15-17, to be repeated four times, separated by 3 min of active recovery at light-moderate intensity (50-70% HRpeak). The interval training sessions will be preceded by a 5-min warm-up and concluded with a 3-min cool-down, with a total exercise time of 33 min per session, three times per week (with at least a day between sessions) for 52 weeks. Supervised (by a qualified exercise professional) exercise sessions will be performed on a treadmill ergometer, either through uphill walking or running.
Control group
Active

Outcomes
Primary outcome [1] 304450 0
Exercise adherence and compliance
Exercise adherence will be assessed as the percentage of sessions completed from the prescribed total number of sessions during the supervised and un-supervised Phases of the study. Compliance will be assessed as the ability to achieve the prescribed exercise intensity and duration of each session. Successful exercise adherence and compliance involves achieving 70% of the exercise protocol targets during each study phase. An exercise training record will be kept for both Phase 1 and 2 of the study. During the supervised phase of the trial, participants will be taught how to monitor and record their exercise intensity using heart rate and/or rating of perceived exertion (RPE).
Timepoint [1] 304450 0
baseline, 16 weeks, 32 weeks, and 52 weeks
The primary time points are baseline and 32 weeks.
Secondary outcome [1] 342008 0
Cardiorespiratory fitness
Cardiorespiratory fitness (VO2peak) will be assessed via indirect calorimetry using an individualized graded maximal treadmill exercise protocol. Ventilation, oxygen and carbon dioxide concentrations will be measured directly during the test via a Parvo® metabolic cart. Following an appropriate warm-up, the workrate (treadmill speed) is progressively increased every minute until the participant can no longer continue [volitional fatigue]. The test lasts approximately 10-15 minutes. Blood pressure, heart rate rhythm (via electrocardiogram) and RPE will be monitored throughout the test to ensure safety of participants.
Timepoint [1] 342008 0
baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [2] 342145 0
Vascular Function
Participants will be asked to fast for 12 hours prior to this measurement , they will also refrain from strenuous exercise for 48 hours and caffeine and alcohol for 24 hours.
In the Lab, after resting for 15 minutes in a supine position, vascular function will be assessed via flow-mediated dilation (FMD) using high-resolution vascular ultrasound (Usmart 3300, Teratech Corporation, Burlinton, USA) in accordance with the current guidelines (Thijssen et al. 2011). A blood pressure cuff will initially be inflated on the participant’s forearm for 5 minutes. Once the cuff is released, blood flow and diameter of the brachial artery will be measured by placing a tiny probe gently against the participant’s upper arm.
Timepoint [2] 342145 0
baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [3] 342146 0
Lipid profile (triglycerides, low-density lipoprotein, high-density lipoprotein, and total cholesterol)
A small sample of blood (~24mL) will be drawn from the participant’s antecubital vein after a 12-hour overnight fast to assess lipid profile. Qualified and experienced phlebotomists will conduct this procedure.
Timepoint [3] 342146 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [4] 342147 0
Body composition and other Anthropometric Measures
Dual-energy x-ray absorptiometry (Hologic Discovery W Apex software version 3.3; Hologic, Bedford, MA) will be used to measure total body fat percentage, visceral adipose tissue, and lean mass via whole-body composition analysis after a 12-hour overnight fast. Height, weight, waist circumference, and hip circumference will also be assessed using current technical recommendations
Timepoint [4] 342147 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [5] 342148 0
Exercise Enjoyment
Exercise enjoyment will be measured using the Physical Activity Enjoyment Scale (PAES).
Timepoint [5] 342148 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [6] 342149 0
Dietary assessment
Dietary intake data will be collected via a standardised 4-day food intake diary, to be completed electronically. Nutrient assessments will use Foodworks™ Nutrition Management system software (Xyris software, Sydney). Dietary intakes relevant to CVD risk will be assessed for Total, Saturated and Trans fatty acid intakes against current Australian Nutrient Reference Values (NRV) (NHMRC, 2006), and adequacy of dietary macro- and micronutrients will be assessed against recommended macronutrient intakes for sports performance. Based on individual participant’s dietary analysis results, dietary advice will be provided by an Accredited Practising Sports Dietitian, with a view to improve sports performance and minimizing risk of micronutrient deficiencies.
Acute dietary advice will not be provided for cardiovascular management until completion of the study, as suggested dietary changes may mask the effects of exercise on cardiometabolic risk factors. However as a duty of care, detailed dietary feedback for prevention or management of CVD risk will be provided to individuals upon completion of the study.
Timepoint [6] 342149 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [7] 342449 0
Arterial stiffness
Participants will be asked to fast for 12 hours prior to this measurement , they will also refrain from strenuous exercise for 48 hours and caffeine and alcohol for 24 hours.
In the Lab they will rest for 15 minutes in a supine position. arterial stiffness will be measured via pulse wave velocity using an automated device (SphygmoCor, AtCor Medical Pty Ltd., West Ryde, Australia). For pulse wave velocity, a cuff will be placed around the upper thigh, and a pen-like tonometer pressure sensor on the participant’s neck to derive a measure of arterial stiffness.
Timepoint [7] 342449 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [8] 342450 0
Central blood pressure
Participants will be asked to fast for 12 hours prior to this measurement , they will also refrain from strenuous exercise for 48 hours and caffeine and alcohol for 24 hours.
In the Lab, after resting for 15 minutes in a supine position, central blood pressure will be assessed via pulse wave analysis using an automated device (SphygmoCor, AtCor Medical Pty Ltd., West Ryde, Australia). For pulse wave analysis, a cuff will be placed around the arm between the elbow and shoulder, and will be partially inflated to obtain a measure of central blood pressure.
Timepoint [8] 342450 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [9] 342451 0
Heart rate variability
Participants will be asked to fast for 12 hours prior to this measurement , they will also refrain from strenuous exercise for 48 hours and caffeine and alcohol for 24 hours.
In the Lab, after resting for 15 minutes in a supine position, heart rate will be recorded continuously for 5 minutes using a heart rate monitor (Polar Electro, Kempele, Finland) to obtain a ‘heart rate variability’ measure.
Timepoint [9] 342451 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [10] 342452 0
Glycemic control
A small sample of blood (~24mL) will be drawn from the participant’s antecubital vein after a 12-hour overnight fast to assess glycemic control Qualified and experienced phlebotomists will conduct this procedure.
Timepoint [10] 342452 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [11] 342453 0
Oxidative Stress (plasma isoprostanes and protein carbonyls)
A small sample of blood (~24mL) will be drawn from the participant’s antecubital vein after a 12-hour overnight fast to assess oxidative stress markers. Qualified and experienced phlebotomists will conduct this procedure.
This is an exploratory outcome.
Timepoint [11] 342453 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [12] 342454 0
Inflammatory Markers (interleukin-22 and high-sensitivity C-reactive protein)
A small sample of blood (~24mL) will be drawn from the participant’s antecubital vein after a 12-hour overnight fast to assess inflammatory markers. Qualified and experienced phlebotomists will conduct this procedure.
This is an exploratory outcome.
Timepoint [12] 342454 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [13] 342455 0
Motivation
Motivation will be measured using the sport motivation scale 2 (SMS-2), a 16-item scale that assesses intrinsic motivation, extrinsic motivation, and a motivation that is widely used in sport settings.
Timepoint [13] 342455 0
Baseline, 16 weeks, 32 weeks, and 52 weeks
Secondary outcome [14] 342456 0
Quality of Life
Quality of life will be assessed using the 12 item Short-Form Health Survey, and the Brief Resilience Scale.
Timepoint [14] 342456 0
Baseline, 16 weeks, 32 weeks, and 52 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria:

The participants have to:
• be > 18 and < 75 yrs of age.
• be willing to participate in either of the exercise programs (marathon training or interval training)
• undergo a pre-exercise screening evaluation according to the Australian Pre-exercise Screening System (APSS) (SMA 2005) and cleared to undertake either exercise program
• recreational runners/exercisers who do not compete in events or have not run in a marathon/half-marathon in the past 12 months.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
• They have been competing or training regularly for 12 months or more; or (b) they have been sent for medical clearance, based on the APSS screening guidelines, and clearance to participate is not provided.

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculation: A sample size calculation was completed using GPower 3.1.9.2 software (Faul, Erdfelder, Lang, & Buchner, 2007). The sample size required to detect a small effect size change of 0.3 with an alpha of 0.05, and power of 0.9 and using T tests of mean differences between adherence rates for the marathon and interval training interventions is 60 participants (30 in each group).
Data Analysis: Between-group differences will be determined via Repeated Measures Analysis of Covariance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/02/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 298401 0
University
Name [1] 298401 0
Flinders University
Country [1] 298401 0
Australia
Funding source category [2] 298402 0
University
Name [2] 298402 0
University of South Australia
Country [2] 298402 0
Australia
Funding source category [3] 298403 0
Commercial sector/Industry
Name [3] 298403 0
His&Her Time Fitness Club
Country [3] 298403 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road, Bedford Park South Australia 5042
Country
Australia
Secondary sponsor category [1] 297532 0
Commercial sector/Industry
Name [1] 297532 0
His&Her Time Fitness Club
Address [1] 297532 0
35 Kauri Parade Seacliff, SA, 5049
Country [1] 297532 0
Australia
Secondary sponsor category [2] 297534 0
University
Name [2] 297534 0
University of South Australia
Address [2] 297534 0
101 Currie St, Adelaide SA 5001
Country [2] 297534 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299397 0
SA HREC (Flinders University)
Ethics committee address [1] 299397 0
Ethics committee country [1] 299397 0
Australia
Date submitted for ethics approval [1] 299397 0
04/12/2017
Approval date [1] 299397 0
Ethics approval number [1] 299397 0

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

Contacts
Principal investigator
Name 80270 0
Dr Joyce S. Ramos
Address 80270 0
Flinders University
Sturt Building, South Wing, Room S268, Sturt Road, Bedford Park South Australia 5042
Country 80270 0
Australia
Phone 80270 0
+61 8 8201 3272
Fax 80270 0
Email 80270 0
[email protected]
Contact person for public queries
Name 80271 0
Claire Drummond
Address 80271 0
Flinders University
Sturt Building, South Wing, Room, Sturt Road, Bedford Park South Australia 5042
Country 80271 0
Australia
Phone 80271 0
+61 8 8201 3424
Fax 80271 0
Email 80271 0
[email protected]
Contact person for scientific queries
Name 80272 0
Lynda Norton
Address 80272 0
Flinders University
Sturt Building, South Wing, Sturt Road, Bedford Park South Australia 5042
Country 80272 0
Australia
Phone 80272 0
+61 8 8201 5830
Fax 80272 0
Email 80272 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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