ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cardiovascular disease

metabolic syndrome

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Metabolic and Endocrine

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]

Behaviour

Intervention code [2]

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]

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]

baseline, 16 weeks, 32 weeks, and 52 weeks
The primary time points are baseline and 32 weeks.

Secondary outcome [1]

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]

baseline, 16 weeks, 32 weeks, and 52 weeks

Secondary outcome [2]

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]

baseline, 16 weeks, 32 weeks, and 52 weeks

Secondary outcome [3]

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]