Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000539134p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2019
Date registered
4/04/2019
Date last updated
4/04/2019
Date data sharing statement initially provided
4/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Heart and lung responses to exercise in adolescents born extremely preterm
Scientific title
Cardiopulmonary responses to acute exercise and physical training in adolescents born extremely preterm
Secondary ID [1] 297505 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extremely Preterm Birth 311696 0
Extremely Low Birth Weight 311697 0
Condition category
Condition code
Cardiovascular 310321 310321 0 0
Normal development and function of the cardiovascular system
Physical Medicine / Rehabilitation 310566 310566 0 0
Other physical medicine / rehabilitation
Reproductive Health and Childbirth 310567 310567 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Intervention
Participants will either be assigned to group 1 or group 2. Group 1 will complete the at-home exercise intervention during the first ten weeks after the initial visit. Group 2 will complete the at-home exercise intervention during the second ten weeks after a second visit. Participants will be provided with a smart bike trainer (T2400 Satori Smart Trainer, Tacx, Wassenaar, Netherlands) which attaches to the back wheel of the participants’ personal bike, converting it into a stationary bike set up. If participants already have a bike, they will be asked to utilise that bike with the smart trainer since it will already be properly sized for the participant. If the participant does not own a bike, one will be provided for the individual. Participants will also be given a heart rate arm band (Wahoo Tickr Fit Heart Rate Arm Band) which will transmit data onto the computer or smart device via Bluetooth. To aid in motivation and maintain retention rates, participants will utilise Zwift, a cycling software program which utilises virtual roads allowing participants to experience a virtual reality-like setting of biking in different locations across the world. All equipment will be provided during the pre-testing visit. In addition, there will be an example of what the stationary bike set-up will look like at RCH and the research coordinator will take the participant through the set-up of the equipment and demonstrate how to use Zwift. The participant will be taught how to mount the bike and proper cycling form will be addressed. Data, including heart rate, distance, duration, and calories will be automatically uploaded (via Zwift) onto Strava for storage, allowing a researcher to access the data from each session via the cloud. Additionally, a set up video (made by the research coordinator) will be provided which the participant can later refer to.
Once the at-home bike system has been set up, the intervention will begin. The research coordinator will be able to monitor the participants adherence via the Strava app and provide positive reinforcement on each session uploaded onto Strava. Examples of positive reinforcement include commenting ‘Good job’ and ‘Keep up the great work’ or providing a ‘kudos’ (i.e. the equivalent to a ‘like’ on social media). There are a total of 28 sessions in this exercise intervention, participants must complete 75% of sessions (21 sessions) to be eligible for the study. This allows for the consideration of potential travel during the holidays and potential illness as any exercise program would have to consider.
If any questions or issues with regards to the at-home set up and/or exercise intervention arise, the participant and/or patient(s) and/or guardian(s) will be able to contact the research coordinator by email or phone call. In addition, the research coordinator will send out a weekly email checking in with each participant as a means of motivation, accountability, and ensuring an open line of communication.
The exercise program is as follows:
Session per Week Duration per Session Intensity Mode
Week 1 2 20 min 55% PHR Stationary Bike Set Up
Week 2 2 20 min 55% PHR Stationary Bike Set Up
Week 3 3 20 min 55% PHR Stationary Bike Set Up
Week 4 3 20 min 55% PHR Stationary Bike Set Up
Week 5 3 20 min 60% PHR Stationary Bike Set Up
Week 6 3 20 min 60% PHR Stationary Bike Set Up
Week 7 3 20 min 65% PHR Stationary Bike Set Up
Week 8 3 20 min 65% PHR Stationary Bike Set Up
Week 9 3 20 min 70% PHR Stationary Bike Set Up
Week 10 3 20 min 70% PHR Stationary Bike Set Up
*Peak Heart Rate (PHR)
Justification: While exercise is important for the general population, it becomes increasingly important for those who are at an increased disease risk. The purpose of the exercise intervention is multifaceted; we wish to establish the potential cardiopulmonary benefits of aerobic training with a cohort who are likely to have reduced cardiopulmonary function and increased risk of cardiovascular disease and reduced quality of life. We also wish to establish the lasting effects of the exercise intervention once it has ended. In addition, we wish to determine if the addition of regular exercise improves quality of life, decreases the perceived barriers to exercise, and reduces stress, anxiety, and depression in adolescent extremely preterm birth/extremely low birth weights.
Intervention code [1] 313747 0
Treatment: Other
Comparator / control treatment
The control group, is born at term and will be receiving the same treatment as the preterm cohort.

Participants will either be assigned to group 1 or group 2. Group 1 will complete the at-home exercise intervention during the first ten weeks after the initial visit. Group 2 will complete the at-home exercise intervention during the second ten weeks after a second visit.
Control group
Active

Outcomes
Primary outcome [1] 319208 0
Cardiopulmonary capacity in adolescents born extremely preterm/extremely low birth weight via maximal stress (maximal oxygen consumption) testing using a cycle ergometer and a metabolic cart.
Timepoint [1] 319208 0
Pre-testing, 10 week intervention, 10 week follow-up
Primary outcome [2] 319645 0
Cardiopulmonary response to exercise in adolescents born extremely preterm/extremely low birth weight by estimating pulmonary pressure estimates via a trans-thoracic echocardiogram and exercising MRI.
Timepoint [2] 319645 0
Pre-testing, 10 week intervention, 10 week follow up.
Secondary outcome [1] 367667 0
Changes in exercise capacity in adolescents born extremely preterm/extremely low birth weight w/ the implementation of an exercise intervention using measures maximal oxygen consumption via a metabolic cart and cycle ergometer.
Timepoint [1] 367667 0
Pre-testing, 10 week intervention, 10 week follow-up
Secondary outcome [2] 367668 0
Aortic flow with exercise in adolescents born extremely preterm/extremely low birth weight by using measures of aortic structure, tapering, and pressure/flow wave patterns via trans-thoracic echocardiogram and cardiovascular MRI .
Timepoint [2] 367668 0
pre testing, and a 10 week exercise intervention (pressure measurements)
Secondary outcome [3] 367669 0
Composite examination of left ventricular structure and function under resting and exercising conditions in adolescents born extremely preterm/extremely low birth weight using measures of stroke volume, ejection fraction, longitudinal strain, cardiac output, ventricular reserve, ventricular chamber dimensions, and ventricular wall thickness via trans-thoracic echocardiogram and cardiovascular MRI.
Timepoint [3] 367669 0
Pre-testing, 10 week intervention, 10 week follow-up
Secondary outcome [4] 367670 0
Composite examination of pulmonary vasculature structure and blood flow dynamics under resting and exercising conditions in adolescents born extremely preterm/extremely low birth weight using measures of pulmonary artery geometry, wave intensity, and flow velocity via a trans-thoracic echocardiogram and a cardiovascular MRI.
Timepoint [4] 367670 0
Pre-Testing, 10 week intervention with pressure measurements, 10 week follow up
Secondary outcome [5] 367671 0
Pulmonary blood pressure under resting and exercising conditions, and the influence of an exercise intervention on pulmonary blood pressure in adolescents born extremely preterm/extremely low birth weight using measures of systolic and diastolic blood pressure of the main pulmonary artery and left and right branching via trans-thoracic echocardiogram and cardiovascular MRI.
Timepoint [5] 367671 0
Pre-testing, 10 week intervention, 10 week follow-up
Secondary outcome [6] 367672 0
Lung capacity under resting and exercise conditions, and with an exercise intervention in adolescents born extremely preterm/extremely low birth weight using measures of dead space, lung volumes, and expiratory rates via spirometry, plethysmography, and multiple breath washout.
Timepoint [6] 367672 0
Pre-testing, 10 week intervention, 10 week follow-up
Secondary outcome [7] 367673 0
Identify facilitators and barriers to exercise in adolescents born extremely preterm/extremely low birth weight using the Adolescent Physical Activity questionnaire, the Adolescent Sedentary Activity Questionnaire, the Exercise Regulations Questionnaire, the Self-Reported Experience of Activity Settings Questionnaire.
Timepoint [7] 367673 0
Pre-testing, 10 week intervention, 10 week follow-up
Secondary outcome [8] 367674 0
Determine if an exercise intervention improves overall quality in adolescents born extremely preterm/extremely low birth weight using the of life the Pediatric Quality of Life Inventory
Timepoint [8] 367674 0
Pre-testing, 10 week intervention, 10 week follow-up

Eligibility
Key inclusion criteria
-Adolescents, aged 14-15 years, who were born EP/ELBW who are current participants in the ongoing VICS study 2005
-Adolescents, age 14 years, who were born at term and are participants as age/sex match controls in the ongoing VICS study 2005
Minimum age
14 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Participants will be excluded if they have limitations which prevent them from exercising safely including…
-Participants deemed moderate or high risk for cardiovascular, metabolic, and pulmonary disease
-Participants with diagnosed cardiovascular, metabolic, and pulmonary disease,
-Musculoskeletal injuries that prevent the participant from participating in everyday life
- Participants on antihypertensive medication
- Participants with a physical or intellectual impairment that would interfere with their ability to be involved in the exercise intervention, such as diagnosed > gross motor function classification system I cerebral palsy, developmental coordination disorder, and autism
-Participants with claustrophobia, as having a measurement MRI would be distressing for such individuals

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a randomized control trial. 38 extremely preterm/extremely low birth weight and 38 controls will be randomly assigned to group 1 (exercise program followed by routine care) or group 2. (routine care followed by exercise program) Each group will consist of 19 extremely preterm/extremely low birth weigh individuals and 19 controls. The randomisation will be determined using a randomisation function in excel. Participants will not need to be blinded for this study, since both groups will be receiving the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparisons between groups before and after acute or chronic exercise will be undertaken using analysis of variance (ANOVA). Descriptive and inferential statistics will be used to analyse general trends within the groups. Associations between variables and preterm birth will first be evaluated to determine if there is an approximate linear relationship (or other), then assessing the strength of the relationship using regression analysis and expressing the strength of the relationship with Pearson’s correlation coefficient. An a-significance value of .05 will be used across all analysis. Comparisons between control and EP/ELBW data will be made using independent t-tests. Paired t-test will be used to make comparisons pre and post exercise intervention. Equivalent non-parametric tests will be used if the data is non-normally distributed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
13/08/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13291 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 25862 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 302064 0
Other
Name [1] 302064 0
Internal sources allocated to Dr Jonathan Mynard at Murdoch Children's Research Institute
Country [1] 302064 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
50 Flemington Rd, Parkville 3052 Vic
Country
Australia
Secondary sponsor category [1] 301876 0
Hospital
Name [1] 301876 0
The Royal Children's Hospital
Address [1] 301876 0
50 Flemington Rd, Parkville 3052 Vic
Country [1] 301876 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302745 0
The Royal Children's Hospital Human Research and Ethics Committee
Ethics committee address [1] 302745 0
Ethics committee country [1] 302745 0
Australia
Date submitted for ethics approval [1] 302745 0
06/03/2019
Approval date [1] 302745 0
Ethics approval number [1] 302745 0

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

Contacts
Principal investigator
Name 91250 0
Miss Melanie Clarke
Address 91250 0
The Murdoch Children's Research Institute
50 Flemington Rd, Parkville Vic 3052
Country 91250 0
Australia
Phone 91250 0
+61 0458-708-949
Fax 91250 0
Email 91250 0
[email protected]
Contact person for public queries
Name 91251 0
Melanie Clarke
Address 91251 0
The Murdoch Children's Research Institute
50 Flemington Rd, Parkville Vic 3052
Country 91251 0
Australia
Phone 91251 0
+61 0458-708-949
Fax 91251 0
Email 91251 0
[email protected]
Contact person for scientific queries
Name 91252 0
Melanie Clarke
Address 91252 0
The Murdoch Children's Research Institute
50 Flemington Rd, Parkville Vic 3052
Country 91252 0
Australia
Phone 91252 0
+61 0458-708-949
Fax 91252 0
Email 91252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseCardiac cycle: an observational/interventional study protocol to characterise cardiopulmonary function and evaluate a home-based cycling program in children and adolescents born extremely preterm.2022https://dx.doi.org/10.1136/bmjopen-2021-057622
N.B. These documents automatically identified may not have been verified by the study sponsor.