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Trial registered on ANZCTR


Registration number
ACTRN12624000861550
Ethics application status
Approved
Date submitted
16/02/2024
Date registered
12/07/2024
Date last updated
12/07/2024
Date data sharing statement initially provided
12/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and type 1 diabetes
Scientific title
The impact of an interprofessional exercise program on improving glycaemic management in children and adolescents with type 1 diabetes.
Secondary ID [1] 309680 0
nil known
Universal Trial Number (UTN)
U1111-1292-7097
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 330039 0
hypoglycaemia 330040 0
hyperglycaemia 330041 0
noctural hypoglycaemia 330043 0
Condition category
Condition code
Metabolic and Endocrine 326946 326946 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children and young adults aged between 12 to 18 with Type 1 diabetes will be recruited from our existing services at The Tweed Hospital, Tweed Community Health, Murwillumbah Community Health, Byron Central Hospital and Byron Community Health.
The exercise intervention will be supervised by qualified exercise physiologists and exercise physiology students. The mode of administration will be determined by the number of recruits, however, is likely to be one to one.
Examples of these exercises are as follows:
1. a sequence of motions for circuit exercise program 1: (1) Twist spine, (2) Hand walking, (3) Rolling squat, (4) Cross knee-up, (5) Jumping & walking, (6) Level-up pacer.
2. sequence of motions for circuit exercise program 2: (1) 8 drill, (2) Star drill, (3) Zig-zag hopping, (4) Side step, (5) Ladder exercise, (6) Hurdle exercise.
3. sequence of motions for circuit exercise program 3: (1) Hand walking, (2) Back extension, (3) Heart fit exercise, (4) Cross hopping, (5) Kick & lunge, (6) Jumping lunge.

The exercise intervention will be the completion of a circuit-based exercise program which is based upon the work by Han and Colleagues (Han, Lee & Shin 2021) designed for adolescents. As participants will have varying levels of fitness, the specialist exercise physiologists will tailor the program based upon the participant’s initial testing, including a cardiorespiratory fitness assessment. The exercise intervention progression plan is based upon 12 weeks, however for participants whose fitness is higher than the expected starting level they will progress to the next “week” (i.e., higher dose of aerobic exercise). Each participant will utilize heart rate monitors, supplied by SCU, which display their real-time exercise heart rate (colour coded to exercise intensity) on a large TV screen in the exercise training facility to allow for continual adjustments in exercise intensity therefore allowing the participant to maintain their prescribed exercise training zone and to ensure their safety. The level of intensity will be moderate to vigorous and will be assessed use the Borg RPE. The duration of the exercise sessions will be for 45 minutes (10 minutes to complete safety checks, and attendance checklist and then 30 minutes exercise and then 5 minutes to complete safety check at the end of the intervention.
Intervention code [1] 326362 0
Lifestyle
Comparator / control treatment
This study is using a pre/post intervention
Comparator - usual management
Control - exercise trial with the use of continuous glucose monitoring sensors (CGMS)
This study is using a pre/post intervention, retrospective continuous glucose monitoring sensors (CGMS) data will be collected for the 3 months prior to the intervention. During the pre-intervention period participants will continue with their usual care which may or may not involve an exercise schedule.
Control group
Active

Outcomes
Primary outcome [1] 335136 0
the total score of Problem Areas in Diabetes (PAID)
Timepoint [1] 335136 0
Baseline - PAID survey
midway during the exercise intervention
Post - PAID survey immediately at completion of exercise intervention.
Primary outcome [2] 335137 0
the score of Diabetes Distress Scale (DDS 1) questionnaires for Type 1 Diabetes mellitus (T1DM)
Timepoint [2] 335137 0
Baseline - DDS
midway during the exercise intervention.
Post - immediately post complication of exercise intervention.
Primary outcome [3] 335138 0
Time In Range from Continuous Glucose Monitoring System (GGMS) data
Timepoint [3] 335138 0
Retrospective data for 12 weeks prior to intervention
weekly over 12 weeks of exercise intervention
12 weeks post intervention data.
Secondary outcome [1] 423226 0
individual item scores of Problem Areas in Diabetes (PAID)
Timepoint [1] 423226 0
Baseline, midway and at completion of exercise intervention.
Secondary outcome [2] 436893 0
incidence hypoglycaemia.
Check of blood glucose levels via a calibrated blood glucose meter.
Timepoint [2] 436893 0
Retrospective data for 12 weeks prior to intervention
weekly over 12 weeks of exercise intervention
12 weeks post intervention data.
Secondary outcome [3] 436894 0
Glucose variability - via data from continuous glucose monitoring devices.
Timepoint [3] 436894 0
Retrospective data for 12 weeks prior to intervention
weekly over 12 weeks of exercise intervention
12 weeks post intervention data.
Secondary outcome [4] 436895 0
Heart rate - via oximeter and heart monitor.
Timepoint [4] 436895 0
Baseline, midway and at completion of exercise intervention.

Eligibility
Key inclusion criteria
inclusion criteria will include.
• Age – 12 to 18 years.
• T1DM
• prior attendance to our multidisciplinary paediatric clinics.
• Participants will need to agree to wear a rtCGMS three months prior to the commencement of the exercise intervention, duration of the study and up to six months post completion so that ongoing data can be collected.
• completion of the PAID and DDS questionnaire by child and care giver or young person as appropriate.
• All participants will need to agree to share their data with the study investigators so that fine tuning of insulin and review of dietary prescriptions can occur on a continuous basis during the study period.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged 2 to 11 years or over 18 years.
T2DM

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
3/03/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24950 0
The Tweed Hospital - Tweed Heads
Recruitment postcode(s) [1] 40602 0
2485 - Tweed Heads

Funding & Sponsors
Funding source category [1] 313872 0
Hospital
Name [1] 313872 0
Tweed Valley Hospital
Country [1] 313872 0
Australia
Primary sponsor type
Hospital
Name
Tweed Community Health
Address
Country
Australia
Secondary sponsor category [1] 315716 0
University
Name [1] 315716 0
Southern Cross University
Address [1] 315716 0
Country [1] 315716 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313021 0
North Coast NSW Human Research Ethics Committee
Ethics committee address [1] 313021 0
http://nnswlhd.health.nsw.gov.au/about/northern-nsw-local-health-district/human-research-ethics-and-governance/
Ethics committee country [1] 313021 0
Australia
Date submitted for ethics approval [1] 313021 0
01/12/2023
Approval date [1] 313021 0
15/02/2024
Ethics approval number [1] 313021 0

Summary
Brief summary
Title: The Impact of an interprofessional exercise program on improving glycaemic management in children and adolescents with type 1 diabetes
Short Title: T1DM & Exercise
Study Sites: Tweed Valley hospital
SCU gymnasium, Bilinga NSW 4225
Study Aims/Objectives/Hypothesis: The aim of this research is to answer the following two research questions.
1. Does participation in an interprofessional exercise program reduce the incidence of exercise induced hypoglycaemia and nocturnal hypoglycaemia?
2. Does participation in an interprofessional exercise program, improve the confidence of individuals and families to manage T1DM?

Study Design: Pre/post intervention trial
Study Outcome Measures: Problem Areas In Diabetes (PAID) (Welch, 1997)
Diabetes Distress Scale (DSS) (Fenwick, 2018)
Physical Activity Questionnaire for Children and Young People (Kowalski, 2004)
Incidence of exercise induced hypo/hyperglycaemia
Nocturnal hypoglycaemia.
Study Population: children and young people between the age of 12 to 18 with T1DM, who are current clients of our Paediatric and Young Adult Diabetes Outpatient clinics
Number of participants: Due to the focus of this study, recruitment will target 12- to 18-year-olds, who attend the Tweed hospital for management of T1DM. We currently see 70 children/young people for T1DM management. On average, over the last two years, 10 children/young people are new to the service each year. We estimate a convenient sample size of approximately 20 to 25 participants from our paediatric and young person’s diabetes service will be eligible to participate.
Translation to Clinical Practice: Development of protocol for exercise physiologists to support children and young people with T1DM to maintain physical activity through the life span.
Key Ethical and Safety Considerations: Management of hypo/hyperglycaemia, trips/slips and falls and developing their confidence in maintaining lifelong exercise. Working with children and young people and ensuring that consent is informed and appropriate based on age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126710 0
Ms Helen Rojas
Address 126710 0
Tweed Valley Hospital, 771 Cudgen Road, Cudgen, NSW 2487
Country 126710 0
Australia
Phone 126710 0
+61 07 5506 7540
Fax 126710 0
Email 126710 0
[email protected]
Contact person for public queries
Name 126711 0
Helen Rojas
Address 126711 0
Tweed Valley Hospital, 771 Cudgen Road, Cudgen, NSW 2487
Country 126711 0
Australia
Phone 126711 0
+61 02 66772400
Fax 126711 0
Email 126711 0
[email protected]
Contact person for scientific queries
Name 126712 0
Helen Rojas
Address 126712 0
Tweed Valley Hospital, 771 Cudgen Road, Cudgen, NSW 2487
Country 126712 0
Australia
Phone 126712 0
+61 07 5506 7540
Fax 126712 0
Email 126712 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?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.