Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000830897
Ethics application status
Approved
Date submitted
29/04/2021
Date registered
29/06/2021
Date last updated
29/06/2021
Date data sharing statement initially provided
29/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Personal Activity Intelligence (PAI) e-health Program for Defence Force and Ex-Service Personnel and immediate family following heart rehabilitation.
Scientific title
Feasibility, Acceptability and Effectiveness of the Personal Activity Intelligence (PAI) e-health Program for Defence Force and Ex-Service Personnel and immediate family following Cardiac Rehabilitation.
Secondary ID [1] 304080 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 321741 0
Myocardial Infarction 321742 0
Coronary artery bypass graft 321743 0
valvular disease 321744 0
valve surgery 321745 0
medically stable angina 321746 0
Valve surgery 321747 0
Stent insertion 321748 0
Condition category
Condition code
Cardiovascular 319481 319481 0 0
Coronary heart disease
Cardiovascular 319482 319482 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional
Intervention Details- the PAI e-health Program:
The program involves the provision of a wrist-worn monitor and 4 x 2-hour group sessions over a 6 week period (i.e. weeks 1, 2, 4 and 6) held at The University of Queensland, St Lucia, Brisbane, Queensland followed by a further 6 weeks of self-directed activity with fortnightly follow-up telephone calls (i.e. weeks 8, 10, and 12). Groups will be between 2-5 participants. This is aimed at educating them about Personal Activity Intelligence (PAI) and their physical activity goals.
At the first session participants will be given a fitness wristband to keep. This measures heart rate when exercising to calculate PAI points. The device is called AMAZFIT GTS wristband. It uses an LED light to illuminate the capillaries around the participants wrist, tracking the velocity of the blood flow and thus, heart rate. Physical Activity Intelligence (PAI) is calculated by an algorithm in the device that uses the participant's heart rate, awarding them with a number of PAI depending on the intensity of the exercise with the goal of reaching 100 PAI per week. Each session will consist of activities that will include:
• PAI-learning
• PAI-playtime
• Behaviour Change Counselling and Interpretive assistance
PAI-learning- This is designed to learn how to use the PAI app on their smartphone, how to activate heart rate recording, how to connect with PAI-buddies and how to troubleshoot problems.
PAI-playtime- During this activity an accredited exercise physiologist (AEP) will guide participants through different types of exercise (for short bouts of 5-10 minutes) at different intensities to see the different ways PAI can be obtained. This will demonstrate different ways to ‘earn’ PAI and include instruction on how to self- direct exercise. Blood pressure and rating of perceived exertion (RPE) will be monitored throughout this session. This activity will last approximately 1 hour.
Behaviour Change Counselling and Interpretive Assistance- Semi-structured discussions and behaviour change techniques will be used to support and enable participants to improve physical activity and exercise adherence using the PAI app for self-monitoring. This activity also involves answering questions and addressing any issues that participants may have.
Participants randomised to the program will be asked to work towards accumulating at least 100 PAI/week for 12 weeks. Program sessions will be under the directorship of CI Dr Burton (clinical health psychologist) and capped at 5 participants per group. During these visits, participants will be given the wrist-worn heart rate device (Amazfit GTS) and educated on the PAI app (freely available for iPhone/iPad and android devices) and metric.
The following 3 group sessions will each follow this format: 1-hour will be used for behavioural counselling including ‘interpretative assistance’ to deepen understanding of the PAI concept and app (including the online PAI e-Health community), discussing experiences using the PAI App, behaviour change problem solving and support; and 1 hour for ‘PAI-playtime’. Between each weekly session, participants will explore and practice using the PAI app. Participants will be given a booklet describing PAI use and examples of exercise sessions that they experienced during the program.
The 100 PAI/week can be achieved by a combination of different exercise types and intensities and the participants can, at any time, get information from the app regarding how many minutes at specified heart rates is needed to achieve the weekly goal of 100 PAI. Via the monitor, participants will receive automatic feedback on a daily basis, and data will be recorded onto a secured server. The PAI e-health group will also be able to invite “buddies” from this project into their “PAI community”. Buddies may see and motivate each other to obtain 100 PAI/week, exchange experiences, etc.
At the end of the face to face sessions, participants shall be able to:
a) use the PAI app: connect app to the heart rate monitor, sync data;
b) join/leave/invite ‘buddies’ into the PAI e-Health community;
c) know where to get PAI help if they experience any technical problems
d) understand the PAI metric and weekly recommendations, and
e) know how to mix and match exercises of varying modality and intensity to reach 100 PAI/week.
In the following six weeks participants will self-direct their physical activity. Participants will receive a fortnightly check-in phone call from the research team to report adverse events and/or technical issues that have not already been reported. If researchers observe no PAI being recorded, participants will also receive a phone call to ascertain whether there are any technical issues. Contact frequency and nature or/reason for contact with project staff will be recorded and reported.
A specifically designed educational booklet will be provided to participants to record experiences and to assist with the behavioural intervention.
Adherence to the intervention will be monitored via session attendance checklists at the university, fortnightly phone calls during self directed home exercise phase as well as via weekly PAI data download.
The intervention will be delivered by a research assistant with a minimum 2 years' experience in clinical exercise physiology and overseen by a physiotherapist.
Intervention code [1] 320410 0
Rehabilitation
Intervention code [2] 320411 0
Lifestyle
Intervention code [3] 320412 0
Behaviour
Comparator / control treatment
Participants allocated to this group will receive a specifically designed written pamphlet explaining the benefits of exercise for cardiovascular health, including general health recommendations to accumulate 150 min of moderate or 75 min of vigorous exercise a week, comprising both aerobic and resistance training. As an attention control strategy, participants will also attend 4 x 1 hour stretching and toning group sessions at The University of Queensland, St Lucia, Brisbane, Queensland performed with an accredited exercise physiologist in weeks 1, 2, 4 and 6. Groups will be between 2-5 participants. This will ensure they will have a similar number of contacts with research staff as the PAI e-Health intervention participants. They will not be given any additional behavioural support. Participants in this group will also be given a wrist-worn heart rate device (Amazfit GTS) and instructions for its use at the end of the study intervention period as a thank-you for their participation in the study. Participants will receive a fortnightly check-in phone call in weeks 8, 10, and 12 from the research team to report adverse events. Contact frequency and nature or/reason for contact with project staff will be recorded and reported.
A specifically designed educational booklet will be provided to participants to record experiences and to assist with the behavioural intervention.
Adherence to stretching sessions will be monitored via session attendance checklists at the university, Participants will receive information about PAI and be issued a smartwatch at the end of the 12 week study period (after final assessments). Due to budget restrictions for this feasibility study, control participants will not undergo the full e-health program.
Control group
Active

Outcomes
Primary outcome [1] 327355 0
Number of days reaching 100 PAI. To determine the number of days a participant has 100 PAI, data will be obtained from the PAI server.
Timepoint [1] 327355 0
Daily from week 2 to week 12 post-intervention commencement with day 7 of week 12 being the primary endpoint.
Primary outcome [2] 327667 0
Number of days reaching 75 PAI. To determine the number of days a participant has 75 PAI, data will be obtained from the PAI server.
Timepoint [2] 327667 0
Daily from week 2 to week 12 post-intervention commencement with day 7 of week 12 being the primary endpoint
Primary outcome [3] 327674 0
Number of days reaching 50 PAI. To determine the number of days a participant has 50 PAI, data will be obtained from the PAI server.
Timepoint [3] 327674 0
Daily from week 2 to week 12 post-intervention commencement with day 7 of week 12 being the primary endpoint
Secondary outcome [1] 394694 0
Change in Cardiorespiratory fitness (VO2peak) using a graded treadmill exercise test to volitional exhaustion. Cardiorespiratory fitness (VO2max) will be assessed via a maximal stress test using a ramp exercise protocol with simultaneous electrocardiogram analysis, under the supervision of the study physician if indicated. Treadmill will be the preferable mode for the test, however an exercise bike will be available for participants with walking limitations. Prior to the test, participants will be asked to avoid exercise, caffeine and tobacco for 24h, and food for 2h. On arrival, participants will rest, seated, for ten minutes, before having two measures of blood pressure taken from the left arm, two minutes apart. A 3-minute rest period will follow, allowing for the measurement of resting pulmonary gas exchange. Treadmill testing will commence with a 4-minute warm-up at 4 km/h and 0% gradient before continuing exercise for a further 4 minutes at a 4% gradient at the same speed. Following the warm-up, participants will perform exercise in continuous 1-minute stages. The speed will increase by 1km/hr every three minutes, the gradient will increase by 1% each minute, until volitional fatigue. For the bike, warm-up will involve participants cycling at a workload corresponding to an RPE 10 at an RPM above 60 for 4 minutes before the intensity is increased by 25-50 watts for a further 4 minutes. Following warm-up, the intensity will be increased by 25 watts each minute until volitional fatigue. Verbal encouragement will be given throughout the test.

Pulmonary gas exchange will be measured using either the Parvo (Parvo Medics TrueOne, Sandy, Utah, USA) or Metamax (Metamax II system, Cortex, Leipzig, Germany) metabolic systems from the start of the rest period, until cessation of the test. The metabolic system and test protocol for a participant, at each assessment, will be identical. Standard calibration procedures according to manufacturer’s instructions will be completed before each exercise test and involve the gas analysers (two-point calibration of known gas concentrations) and volume (Hans RudolphTM 3L calibration syringe). O2, carbon dioxide production ( CO2) and minute ventilation ( E), sampled using ten-second rolling averages, will be recorded throughout the test and stored for later analysis. Simultaneous electrocardiogram (ECG) recording (CASE Exercise Testing System, Milwaukee, WI, USA) and analysis will also take place during the test. Recording of the heart rate will occur at regular intervals including before the test, every minute during warm-up, and at the end of each minute during the exercise test. Heart rate recovery will also be assessed by recording heart rate at cessation and at 1-, 2-, 3-, and 5-minutes post-exercise. Blood pressure will be measured at rest and every 3-minutes from the beginning of warm- up, as well as 1-minute, 3-minutes, and 5-minutes post-test. RPE will be monitored at the end of each warm-up stage, every minute during the exercise test, and at cessation.
On the first study visit (Visit 1), a familiarisation (i.e. practice) CPET will be conducted to get the participant familiar with the set up and process of the maximal fitness test. Participants will complete the warm up and stage 1 only. This increases the robustness of the maximal CPET in the final assessment visit (Visit 3).
This is a description of the outcome measure (Cardiorespiratory fitness) protocol and is composite of Pulmonary exchange. ECG, RPE and blood pressure).
Timepoint [1] 394694 0
Baseline and on completion of trial (12 weeks post-intervention commencement)
Secondary outcome [2] 394695 0
Change in physical activity levels will be quantified via an Actigraph accelerometer, worn for 7 consecutive days.
Timepoint [2] 394695 0
At baseline and on completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [3] 394696 0
Change in Physical Activity levels: The International Physical Activity Questionnaire (IPAQ- short form), will be administered to identify potentially eligible volunteers who are meeting physical activity guidelines. IPAQ was developed to establish a standardized and culturally adaptable measurement tool for measuring physical activity in different cultures of the world.
Timepoint [3] 394696 0
Baseline and on completion of trial (12 weeks post-intervention commencement)..
Secondary outcome [4] 394697 0
Change in exercise capacity. The Six-Minute Walk Test (6MWT) will be utilised to give an indication of exercise capacity, conducted according to standardised procedures. The 6MWT measures the distance the participant can quickly walk in 6 minutes, while self-pacing and resting as needed. It involves the assessor laying out a 30 metre track, with increments every metre. Baseline heart rate (bpm) and blood pressure will be taken from participants in a seated position before starting the test. Participants will be asked to complete as many laps as possible during the 6 minute period. The assessor will keep a tally of completed laps throughout, and instruct participants using a standardised script. Post-test, participants will have RPE, blood pressure and heart rate recorded again in a seated position. The result of the 6MWT will be distance walked rounded to the nearest metre.
Timepoint [4] 394697 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [5] 394698 0
Change in body composition: Dual-energy x-ray absorptiometry (DXA, Hologic Horizon A) will be used to determine body composition (this includes a composite of total bodyweight, total body lean tissue mass, total body fat mass, total body fat percentage). All measures will be quantified and analysed as per manufacturer instruction. While we expect the mean age of participants to be ~50-60years (based off previous research experience) our inclusion criteria is 18-79 years. Initial screening will include a question regarding intention to become pregnant and those who are intending will be excluded. As the dose of radiation associated with DXA is very low dose (<0.1mSv) we will not give recognised pregnancy tests.
Timepoint [5] 394698 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [6] 394699 0
Change in Body Mass Index (BMI), BMI will be calculated by taking a height measurement (Stature will be measured by stadiometer in centimeters) and weight measurement (Avery Weigh-Tronix AWB 120 Bench scales will be used and weight will be recoded in kilograms). These height and weight measurements will be used to calculate BMI using the formula BMI = kg/m2.
Timepoint [6] 394699 0
At baseline and completion of the trial Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [7] 394700 0
Change in Systolic and diastolic blood pressure (mmHg, in triplicate): Blood pressure will be taken with a manual cuff after 10-15 minutes of quiet, relaxed sitting. Participants will be asked to keep breathing normally and refrain from talking during the procedure. Blood pressure will be checked in both arms at the first examination. When there is a consistent inter-arm difference, the arm with the higher pressure should be used. The second measure should be taken on the alternate arm. If there is >10 mmHg difference between measures, a third measure should be taken on the arm with the higher reading. For resting heart rate the radial pulse will be palpated and recorded for 60 s. Two measures will be recorded and if there is a difference >10 beats per minute record a third measurement.
Timepoint [7] 394700 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [8] 394701 0
Change in The Framingham Risk Score
Timepoint [8] 394701 0
Baseline and on completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [9] 394703 0
Change in Aortic stiffness: will be measured using the pulse wave velocity (PWV) technique with a SphygmoCor XCEL automated blood pressure device (AtCor Medical, West Ryde, NSW, Australia) while participants lie in a supine position. To assess PWV, pulse waves will be monitored at the carotid artery (neck) by a hand-held tonometer, and simultaneously pulse waves will be monitored at the femoral artery using a low pressure pneumatic thigh cuff which will remain partially inflated over a period of 20-60 seconds. This procedure does not cause any discomfort. PWV is determined by calculating the ratio of the distance between the carotid and femoral arteries to the transit time; measured as the time delay between the arrival of the pulse wave at the common carotid artery and the common femoral artery.
Timepoint [9] 394703 0
At baseline and on completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [10] 394704 0
Change in Vascular function will be assessed via brachial artery flow mediated dilatation (FMD) in accordance with published guidelines. Using a high-resolution duplex ultrasound machine (model T3000, Terason, Burlington, MA), we will image the brachial artery for simultaneous recording of brachial diameter and blood velocity before and after a 5-min ischaemic stimulus, using a forearm cuff (Figure 3). Diameter and flow will be assessed at rest (1 minute) and for 3 minutes following a 5 minute period of forearm occlusion (ischemia) using a pneumatic cuff placed
immediately distal to the elbow joint (>220mmHg). Using edge detection software, FMD will be calculated as peak diameter – baseline diameter/baseline diameter and expressed as % change.
Timepoint [10] 394704 0
At baseline and on completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [11] 394705 0
Change in Central blood pressure and wave reflection characteristics: Brachial artery waveforms will be recorded from the right upper arm using the Sphygmocor Xcel (AtCor Medical) following standard guidelines. Pressures that will be measured are: central systolic, central diastolic, central pulse pressure, mean arterial pressure, augmentation pressure, and augmentation index. Wave separation analysis will estimate the aortic pressure wave. The forward (Pf) and reflected (Pb) pressure waves correspond to the peak and the end of the assumed flow wave, respectively. The reflection magnitude (RM) is calculated as the ratio of the Pb to the Pf (RM = Pb/Pf ×100).
Timepoint [11] 394705 0
Baseline and on completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [12] 394706 0
Change in Augmentation Index (AIx): Brachial artery blood pressure will be measured using the automated device. Following BP measurement, the arm cuff is inflated to a light pressure just above diastolic pressure for 10 seconds. During this time pressure waves are sampled for the measurement of AIx. The central aortic pulse wave will be used to determine the ratio of wave reflection amplitude to central pulse pressure. This procedure causes no discomfort and is similar to a standard blood pressure measurement.
Timepoint [12] 394706 0
Baseline and on completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [13] 394707 0
Change in blood measures- fasting samples will be analysed for a composite of cardiometabolic risk: lipid profiles, glucose and insulin by a NATA accredited laboratory (QML). The lipid profile from plasma will include assessment of total cholesterol (TC), very low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), high-sensitive C- reactive protein (hsCRP) and triglycerides (TG). From these, the very low-density lipoprotein and cholesterol to HDL ratio will be calculated.
Timepoint [13] 394707 0
Baseline and on completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [14] 394708 0
Change in perceived wellbeing, and health related variables:
SF-36 measures physical and mental health based on 8 health concepts: physical and social functioning, role limitations due to physical and emotional problems, mental health, vitality, bodily pain, and general health perception
Timepoint [14] 394708 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [15] 394709 0
Feedback on participant experience of the PAI eHealth program and AmazFit smartwatch will also be obtained from the intervention group via survey which is readily designed for this study and one-on-one interviews. Interviews will be recorded and transcribed verbatim with use of Otter Software (that records voice as text). All text will be reviewed and compared against the original recording with manual edits made where necessary. Participants will be provided with the opportunity to review their transcripts, to ensure their responses and views are conveyed to their satisfaction. Intervention participants will be asked to respond to additional items to obtain feedback on using PAI (e.g. comprehension, ease of use, satisfaction). Recordings will be deleted after transcripts are finalised.
Timepoint [15] 394709 0
On completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [16] 394710 0
Number of adverse events. Safety will be assessed by monitoring adverse events. All participants will be asked to record any physical symptoms (e.g., extreme breathlessness, chest pain), musculoskeletal injuries, falls, acute illnesses and changes in health status/meds. These will be recorded in a diary provided to the participants. Bi-monthly phone calls will be made to all participants to obtain ongoing safety data.
Timepoint [16] 394710 0
From commencement through to completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [17] 394711 0
Change in dietary Intake: Participants will complete a 3-day food diary, using the research-version of the Easy Diet Diary App (https://easydietdiary.com/). Dietary data will be extracted from this application and input into FoodworksTM, providing information on food group serves. Participants will have the option of completing their 3 day food record manually (paper based) if preferred.
Timepoint [17] 394711 0
Baseline and on completion of the trial (12 weeks post-intervention commencement).
Secondary outcome [18] 394712 0
Changes in scores from Psychological Well being Index which assesses psychological distress across dimensions of:(i) anxiety, (ii) depressed mood, (iii) positive well-being, (iv) self-control, (v) general health, and (vi) vitality.
Timepoint [18] 394712 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [19] 396193 0
Waist circumference: waist circumference will be measured against the skin (no shirt/material between the tape and the skin) to the nearest 0.1 cm using a metal retractable tape (Fibreglass measuring tape, Guilick II, Country Technology Inc. Wisconsin USA). Waist circumference will be measured at the midpoint between the lowest rib and the iliac crest; location of measurement will be identified by palpation of the bony landmarks, then using the tape measure to locate the midpoint between the two landmarks. All measures will be taken in triplicate.
Timepoint [19] 396193 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [20] 396194 0
Hip Circumference: Hip circumference will be taken at the greater trochanter. All measures will be taken in triplicate.
Timepoint [20] 396194 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [21] 396195 0
Height: Stature will be measured by stadiometer in centimeters
Timepoint [21] 396195 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [22] 396196 0
Body Weight: Avery Weigh-Tronix AWB 120 Bench scales will be used and weight will be recoded in kilograms.
Timepoint [22] 396196 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [23] 396197 0
Australian and New Zealand 5 year and 10 year Cardiovascular Risk Calculator- composite outcome
Timepoint [23] 396197 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [24] 396198 0
Change in physical activity levels will be quantified via an activity log given to participants that is specifically designed for this trial.
Timepoint [24] 396198 0
Baseline and on completion of trial (12 weeks post-intervention commencement).
Secondary outcome [25] 396201 0
Number of days reaching 25 PAI. To determine the number of days a participant has 25 PAI, data will be obtained from the PAI server.
THIS IS A PRIMARY OUTCOME
Timepoint [25] 396201 0
Daily from week 2 to week 12 post-intervention commencement with day 7 of week 12 being the primary endpoint.
Secondary outcome [26] 396324 0
Change in resting heart rate. For resting heart rate the radial pulse will be palpated and recorded for 60 s. Two measures will be recorded and if there is a difference >10 beats per minute record a third measurement.
Timepoint [26] 396324 0
Baseline and on completion of trial (12 weeks post-intervention commencement).

Eligibility
Key inclusion criteria
Defence Force or Ex serving personnel and/or immediate family (spouse and/or first degree relative) that has completed a cardiac rehabilitation programme within the last 12 months.
Cardiac rehabilitation participants may have suffered a myocardial infarction, undergone coronary artery bypass surgery, valvular surgery and/or stent insertion.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years and over 79 years
Congestive heart failure
Primarily diagnosed with peripheral artery disease
Currently participating in a physical activity program (e.g. Heart Health).
Any medical condition where exercise is contraindicated, atrial fibrillation or other significant arrhythmias.
Significant cognitive impairment
alcohol abuse
limited life expectancy (< six months), or any other condition preventing an ability to perform physical activity.
Currently meeting physical activity guidelines (150 min/week moderate activity or 75 min/week vigorous activity or a combination of both).
Those that do not have a smartphone and/or are not willing and able to access the study site,
Those who are currently pregnant or intending to become pregnant in the next five months

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)
Randomisation: will be performed using a web-based (sealed envelope) process concealing the randomisation procedure. Randomisation will be conducted by a staff member from The University of Queensland who is not an investigator on the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant in the study will be randomised by simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) It will not be possible to determine any of the participant characteristics or which study group they are from. All data sheets and samples will be labelled with the participant code, and this will ensure that the investigators responsible for data analysis are blinded as to the group each participant is from.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All primary and secondary outcomes will be analysed on an intention-to-treat basis using Statistical Package for the Social Sciences (SPSS). A biostatistician will support the study and assist with data analyses.
Feasibility data will be presented descriptively. Between group differences will be assessed using an ANCOVA adjusting for the baseline measure. Confidence intervals will be adjusted using a Bonferroni approach. Non-normally distributed variables will be transformed prior to analysis. Model residuals will be checked to ensure the assumptions of the model were satisfied. All analyses will performed be performed using SPSS version 26 (SPSS Inc, Chicago, USA), Significance was considered when p<0.05.
All potentially confounding factors (e.g. medication use, age) will be controlled for in statistical analyses. As per statistical advice from our biostatistics team, if baseline data are missing then a group mean will be imputed for the missing data point. Given the purpose, design and size of the trial, if data are missing at post-intervention, no imputation will occur; the data point will be left missing
Although this is a feasibility study, the sample size of 30 participants should give sufficient statistical power (=0.80) to analyse the group differences in the changes in cardiorespiratory fitness and other cardiometabolic health markers.
Assuming a correlation of 0.5 between baseline and post-intervention cardiorespiratory fitness and an effect size of 1.02 (change of 3.5 ml/kg/min in intervention and no change in control with a pooled SD of 3.43 ml/kg/min), we require 12 participants per arm to achieve 80% power to detect a significant difference at the 5% level (two-sided) using ANCOVA. With six participants lost to follow up (based on our previous work in related fields), we will recruit 30 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/07/2021
Actual
Date of last participant enrolment
Anticipated
1/11/2021
Actual
Date of last data collection
Anticipated
4/02/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19239 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 19240 0
The Wesley Hospital - Auchenflower
Recruitment hospital [3] 19241 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [4] 19242 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment postcode(s) [1] 33813 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 33814 0
4066 - Auchenflower
Recruitment postcode(s) [3] 33815 0
4120 - Greenslopes
Recruitment postcode(s) [4] 33816 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 308464 0
Charities/Societies/Foundations
Name [1] 308464 0
Defence Health Foundation
Country [1] 308464 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Human Movement and Nutrition Sciences
The University of Queensland
Human Movement Studies Building (#26B)
St Lucia, 4072
Queensland, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 309303 0
None
Name [1] 309303 0
NA
Address [1] 309303 0
NA
Country [1] 309303 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308419 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 308419 0
Ethics committee country [1] 308419 0
Australia
Date submitted for ethics approval [1] 308419 0
02/02/2021
Approval date [1] 308419 0
16/03/2021
Ethics approval number [1] 308419 0
HREC/2021/QMS/72984
Ethics committee name [2] 308424 0
Uniting Care Health Human Research Ethics Committee
Ethics committee address [2] 308424 0
Ethics committee country [2] 308424 0
Australia
Date submitted for ethics approval [2] 308424 0
08/04/2021
Approval date [2] 308424 0
26/04/2021
Ethics approval number [2] 308424 0
2021.05.343
Ethics committee name [3] 308425 0
Departments of Defence and Veterans" Affairs Human Research Ethics Committee
Ethics committee address [3] 308425 0
Ethics committee country [3] 308425 0
Australia
Date submitted for ethics approval [3] 308425 0
15/03/2021
Approval date [3] 308425 0
28/05/2021
Ethics approval number [3] 308425 0
20210316 (1258h) REO

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

Contacts
Principal investigator
Name 110650 0
Dr Shelley Keating
Address 110650 0
Rm 406, Building 26B
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia Brisbane Queensland 4072 Australia
Country 110650 0
Australia
Phone 110650 0
+61733469999
Fax 110650 0
Email 110650 0
[email protected]
Contact person for public queries
Name 110651 0
Amanda Hannan
Address 110651 0
Rm 406, Building 26B
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia Brisbane Queensland 4072 Australia
Country 110651 0
Australia
Phone 110651 0
+61 415510772
Fax 110651 0
Email 110651 0
[email protected]
Contact person for scientific queries
Name 110652 0
Shelley Keating
Address 110652 0
Rm 406, Building 26B
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia Brisbane Queensland 4072 Australia
Country 110652 0
Australia
Phone 110652 0
+61733469999
Fax 110652 0
Email 110652 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial in a non-identifiable form. If the participant has given extended consent, group mean and standard deviations for all outcome data will be shared on request to the PI. For example for the purpose of meta analysis where data not reported in suitable format in the publication.

Data that will be shared are clinical outcome data.
When will data be available (start and end dates)?
After publication of results (estimated to be Dec 2022) and will be available for 15 years (Dec 2037).
Available to whom?
People from credentialed institutions upon request by email to PI- Dr Shelley Keating.
Available for what types of analyses?
Meta-analysis or other pooled analysis of raw data. All data to be shared will be de-identified.
How or where can data be obtained?
upon request by email to PI- Dr Shelley Keating.
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11525Statistical analysis plan  [email protected] Plan can be requested by Dr Shelley Keating by ema... [More Details]



Results publications and other study-related documents

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