Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000971235p
Ethics application status
Not yet submitted
Date submitted
5/06/2018
Date registered
8/06/2018
Date last updated
8/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can high intensity interval training improve the heart health of truck drivers?
Scientific title
Truck-Fit: Testing of a scalable high intensity interval training program to improve cardiorespiratory fitness in male long distance truck drivers with cardio-metabolic risks and conditions.
Secondary ID [1] 295087 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiorespiratory fitness 308147 0
sleep quality 308148 0
fatigue 308149 0
Condition category
Condition code
Public Health 307191 307191 0 0
Health promotion/education
Cardiovascular 307192 307192 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drivers in the intervention condition will be asked to complete three-weekly sessions of high intensity interval training over 16 weeks, incorporating a 3-minute warm-up (60-70% HRpeak), followed by one high intensity 4-minute bout of exercise (85-95% HRpeak), and a 1-minute cool down. The total time for each session will be 8 minutes, with HRpeak determined from a baseline VO2peak exercise test administered during a participant screening process.

Initially, HIIT sessions will be supervised by an accredited exercise physiologist (AEP), but the number of supervised sessions will be gradually phased out across 16 weeks, as drivers are trained and educated towards self-administration of three non-supervised sessions/week during the final four weeks. This delivery pattern in real world conditions provides an ideal model for assessing key behaviour change support components linked to compliance, as will occur as follows: Weeks 1-4 = 3 supervised sessions/week; Weeks 5-8 = 2 supervised & 1 non-supervised sessions/week; Weeks 9-12 =1 supervised and 2 non-supervised sessions/week; Weeks 13-16 = 3 non-supervised sessions/week.

The program will begin with a single, 2 hour AEP-led workshop where through an interactive, educational workshop, drivers will review program benefits, goals and logistics. At this point, drivers will also receive a project pack with a diary for recording observations, program experiences, and sessions completed. For supervised sessions, the AEP will deliver HIIT at a centralised facility, to groups of up to 5 drivers during pre-driving routines. During these sessions drivers will be prescribed exercise via cycle ergometers provided by the research team, and choose with the AEP from a range of suitable calisthenic exercises (e.g. high knee jogging, or stair stepping) that elicit a similar high intensity heart rate response; wear heart rate monitors to learn to rate perceived exertion (RPE) relative to monitored target heart rates (with HIIT rated as an RPE of 16-18 on a scale of 6-20); identify suitable locations other than the depot (e.g. truck stops or home) where these exercises could occur; engage with a range of behavioural support resources developed and tested through our previous work with drivers (i.e. feedback, self-monitoring and peer support strategies), to promote program compliance and maintenance as AEP contact gradually reduces across the 16-week program.
Intervention code [1] 301421 0
Behaviour
Comparator / control treatment
Usual behaviour, whereby drivers will maintain their normal non-active lifestyle.
Control group
Active

Outcomes
Primary outcome [1] 306139 0
The primary outcome of cardiorespiratory fitness (VO2max) will be measured using a cycle ergometer graded exercise test to exhaustion. A one-minute ramp protocol will be used, with expired air collected throughout for assessment of maximal oxygen uptake.
Timepoint [1] 306139 0
Baseline and end-intervention (16 weeks)
Secondary outcome [1] 347710 0
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index* administered during laboratory visits; this questionnaire is a widely used measure with demonstrated validity that assesses overall sleep quality, daytime dysfunction, sleep duration, and efficiency.

*Buysse DJ, Reynolds CF, Monk TH et al. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 1989; 28: 193-213
Timepoint [1] 347710 0
Baseline and end-intervention (16 weeks)
Secondary outcome [2] 347711 0
For fatigue, a validated psychomotor vigilance questionnaire* will be administered via touch pad, thus enabling us to collect data conveniently and quickly at depots as drivers’ complete their shifts.

* Balkin TJ, Horrey WJ, Graeber RC et al. The challenges and opportunities of technological approaches to fatigue management. Accid Anal Prev 2011; 43: 565-572.
Timepoint [2] 347711 0
Baseline and end-intervention (16 weeks)
Secondary outcome [3] 347712 0
For driving performance we will test a subset of participants (20/group based on testing time and logistics) in a fixed-base driving simulator located at our sensorimotor performance laboratory. The device will be used to measure driver performance based on a composite number of ecologically valid tasks that will include; braking response times (in response to vehicles emerging from a side-road); speed regulation (in accordance with road-side signage); and lane holding (lane deviation and frequency analysis of steering movements).
Timepoint [3] 347712 0
Baseline and end-intervention (16 weeks)
Secondary outcome [4] 347778 0
HIIT compliance (frequency of sessions and exercise intensity achieved) will be assessed using the following composite measures; AEP logs of completed supervised sessions, and heart rate response and RPE; drivers will record these data in their personal logs for unsupervised sessions.
Timepoint [4] 347778 0
Across the 16 week program
Secondary outcome [5] 347782 0
User focus groups and interviews will be used to capture qualitative data. We will invite two groups of ten drivers who used ‘Truck-Fit’ to discuss program experiences at week 16; these data will capture driver insights into factors that facilitated or inhibited program compliance and maintenance. Depot manager and AEP interviews will be conducted separately at these times, to capture perspectives from those engaged in delivering and staging the intervention.

Focus groups and interviews will be recorded and transcribed. Members of the research team will thematically analyse and independently review these data, and then discuss the range of driver, management, and AEP responses, to inform ongoing program development.

Lastly, we will contact drivers who drop out of the trial, with the aim of identifying reasons for attrition.
Timepoint [5] 347782 0
End-intervention (week 16)

Eligibility
Key inclusion criteria
To be eligible, drivers should be able to perform exercise without severe muscle, bone or joint pain; and present with 2 or more chronic disease risk factors (to include no or little moderate/vigorous exercise or leisure time physical activity as an indicator of low cardiorespiratory fitness, as well as one other risk factor such as family history of heart disease).
Minimum age
45 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
All drivers who meet initial eligibility criteria will enter the baseline stage of the study, and attend our university exercise laboratory for clinical screening prior to entering the next phases of the study. This will include a cycle ergometer exercise stress test, supervised by a medical doctor, who will apply clinical exclusion criteria (cardiac arrhythmias, or systolic BP> 200 mm Hg and/or diastolic BP > 110 mm Hg at rest). Those who may be excluded from further participation will receive feedback on their results and be referred to their medical practitioner for ongoing care and support.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
26/07/2019
Actual
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
148
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299670 0
Self funded/Unfunded
Name [1] 299670 0
Country [1] 299670 0
Primary sponsor type
Individual
Name
Ass/Prof Nicholas Gilson
Address
School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia Campus, Brisbane, Qld, Australia, 4074.
Country
Australia
Secondary sponsor category [1] 299014 0
None
Name [1] 299014 0
None
Address [1] 299014 0
None
Country [1] 299014 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300577 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 300577 0
Ethics committee country [1] 300577 0
Australia
Date submitted for ethics approval [1] 300577 0
28/09/2018
Approval date [1] 300577 0
Ethics approval number [1] 300577 0

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

Contacts
Principal investigator
Name 84086 0
A/Prof Nicholas Gilson
Address 84086 0
The School of Human Movement and Nutrition Sciences,
The University of Queensland,
St Lucia Campus,
Brisbane, Qld, 4074.
Country 84086 0
Australia
Phone 84086 0
+61 7 336 56114
Fax 84086 0
Email 84086 0
[email protected]
Contact person for public queries
Name 84087 0
Nicholas Gilson
Address 84087 0
The School of Human Movement and Nutrition Sciences,
The University of Queensland,
St Lucia Campus,
Brisbane, Qld, 4074.
Country 84087 0
Australia
Phone 84087 0
+61 7 336 56114
Fax 84087 0
Email 84087 0
[email protected]
Contact person for scientific queries
Name 84088 0
Nicholas Gilson
Address 84088 0
The School of Human Movement and Nutrition Sciences,
The University of Queensland,
St Lucia Campus,
Brisbane, Qld, 4074.
Country 84088 0
Australia
Phone 84088 0
+61 7 336 56114
Fax 84088 0
Email 84088 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
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