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Trial registered on ANZCTR


Registration number
ACTRN12622000385741
Ethics application status
Approved
Date submitted
22/02/2022
Date registered
4/03/2022
Date last updated
3/06/2024
Date data sharing statement initially provided
4/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of physical activity and exercise on glycaemic control in cystic fibrosis
Scientific title
Effects of physical activity and exercise on glycaemic control in cystic fibrosis
Secondary ID [1] 306499 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 325362 0
Cystic Fibrosis related diabetes 325363 0
Condition category
Condition code
Respiratory 322747 322747 0 0
Other respiratory disorders / diseases
Metabolic and Endocrine 322748 322748 0 0
Diabetes
Human Genetics and Inherited Disorders 322810 322810 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who meet the inclusion criteria will be invited to participate in a 10 day research study when they attend a routine Royal Prince Alfred Cystic Fibrosis(CF) clinic appointment. If they provide consent to participate in the study, they will be provided with a continuous flash glucose monitor (CGM, FreeStyle LibreTM 2 Abbott Diabetes Care) and an activity monitor (activPALTM, PAL Technologies) either at CF clinic or by mail. The FreeStyle LibreTM 2 is a standard device used for glucose monitoring in diabetes clinics worldwide . Instructions on how to use the CGM will be provided by the CF Clinic diabetes educator either in person or via telehealth at the start of the trial. The activPAL is a validated device used for activity monitoring, including analyses of physical activity and sedentary behaviour . Instructions on how to use the activPAL device will be provided by one of the Physiotherapists involved in the trial. The first day of CGM and activity monitoring will be Day 1 of the trial. Participants will be instructed to maintain their usual physical activity and exercise routines, as well as continue their usual diet and medication regimens for the study period. CF participants will be asked to complete four questionnaires at study entry: Clarkes hypoglycaemia awareness survey; participant hypoglycaemia questionnaire; Edinburgh hypoglycaemia symptom scale and the CFQ-R, a CF-specific health-related quality of life questionnaire . The questionnaires will be completed securely online via REDCap. Healthy control participants will be invited to complete the same questionnaires, except for the CFQ-R (for a total of three questionnaires). Participants will be provided with a one page activity, food and insulin diary to record sleeping and waking times, details of any exercise, timing and carbohydrate content of meals, and if prescribed, timing and dosage of insulin. Patients will be advised to use usual prandial insulin before exercise as per their usual routine. The participants will then be booked to have one 20-minute moderate intensity exercise session at the Queen Elizabeth II Pulmonary Rehabilitation, Royal Prince Alfred Hospital, Camperdown, NSW, between Day 4 and Day 8. The exercise will be performed on a stationary cycle (Ergoselect 5, ergoline GmbH, Germany) and participants will be monitored according to standard protocols for the Exercise Lab (ECG, oxygen saturation, blood pressure and metabolic measures). This session will be supervised and tailored for each patient by one of the physiotherapists involved in the study, who all have expertise in exercise testing and training. The workload on the cycle will be titrated to achieve 60-70% of estimated peak heart rate and a reported breathlessness score of moderate-somewhat severe, as per pulmonary rehabilitation guidelines. A physician will also be available to provide supervision if needed. Participants will be observed for one hour after completion of the exercise session and provided with a hypoglycaemia kit (fast and long acting carbohydrate) if they show any sign of hypoglycaemia. They are then able to return home and will be advised to perform their regular activity and exercise routines at any time convenient to them until trial completion at Day 10. After completion of the study (Day 11), the participants can discard the CGM in a biohazard sharps bin in their own home. This will be provided to them. Glucose monitoring results will be remotely downloaded using LibreviewTM as per current standard of care, a cloud platform allowing access to glucose data with established security protocols. This secure, protected cloud-based diabetes management system allows glucose readings to be uploaded from LibreLink systems and reviewed. For both patients and healthcare professionals to access LibreviewTM they must have an account which is password protected. Healthcare professionals must also be approved by admin of the ‘Practice’ so that they can access patient’s glucose readings.

Post-TrikaftaTM study
If Trikafta becomes available on the PBS between 2021 and 2023, participants who completed the pre-Trikafta component of the study will be invited to complete this study a second time, after 4 weeks post Trikafta initiation. Approximately 90 % of patients with CF will become eligible for this medication once on PBS and will become standard of care. This is an oral medication that is used twice a day at the dose of 100/50/75 mg. Monitoring of adherence will be usual clinically practice as well as usual monitoring with required pathology testing. This medication will be used ongoing unrelated to the study process. There will be no changes for the previously described protocol except that they will now be on a new medication.
The data of the post Trikafta group will be compared to exercise only group as well as healthy volunteers.

Healthy Control Participants
Healthy control (HC) participants without CF will be recruited via advertisement placed in the clinic waiting room.
Body Composition Substudy:
Participants will also be invited to undergo a body composition scan at the RPAH Endocrine department prior to their exercise study at the QEII gym.
Intervention code [1] 322926 0
Lifestyle
Comparator / control treatment
Healthy control group. This group will undergo the same intervention protocol with same exercise regimen, continuous flash glucometer and actiPal.
Control group
Active

Outcomes
Primary outcome [1] 330551 0
Blood glucose control monitored with continuous flash glucometer related to exercise measured withactiPal
Timepoint [1] 330551 0
Continous monitoring of blood glucose for 10 days
Secondary outcome [1] 406646 0
Blood glucose control monitored with continuous flash glucometer related to exercise measured with actiPal following initiation of Trikafta
Timepoint [1] 406646 0
4 weeks after initial observation
Secondary outcome [2] 406647 0
Body composition via Dual Energy X-ray Absorptiometry before and after commencement of Trikafta.
Timepoint [2] 406647 0
Before and within 1 year after commencement of Trikafta.

Eligibility
Key inclusion criteria
a.RPAH CF clinic patients, aged 17 years and over, who are clinically stable.
b. CF Patients with Cystic fibrosis related diabetes( CFRD) (n=15), impaired fasting glucose tolerance (n=15) and those with normal glycaemic control (n=15), according to their most recent oral glucose tolerance test (within 3 years, where applicable).
c. Clinically-stable at time of data collection, as assessed by the patient’s treating respiratory physician, including no non-routine antibiotics in the previous 14 days.

d. Provides informed consent. e. Eligible for Elexacaftor/Tezacaftor/ Ivacaftor (TrikaftaTM) · Healthy control participants:
. Healthy clinically stable participants, aged 17 years and over.
No history of cardiovascular, neuromuscular, endocrine, respiratory disease
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a. Unable to perform moderate intensity exercise or use continuous glucose monitoring device. b. Colonisation with Tier 3 organisms (Burkholderia cepacia, non-tuberculous mycobacteria) c. Previous lung transplant. d. Pregnant or lactating females. e. Known hypoglycaemia unawareness f. Mobile phone not compatible with the continuous glucose monitoring devic

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
Statistical methods / analysis
This is a pilot study evaluating the impact of physical activity and exercise on glycaemic control in patients with CF. Descriptive data will be expressed as mean ± SD, unless otherwise stated. Pair-wise comparisons will be tested by paired t-test or Wilcoxon signed-rank test depending on the normality of data distribution. Unpaired t-tests and Mann-Whitney U tests will be used for between group comparisons where appropriate. Associations will be tested by either Pearson or Spearman tests also based on normality of distribution. The ActivPal data will be used to identify “exercise days” and “sedentary days”. For exercise days, we will divide time into 4hr blocks for the 24hr post exercise and assess the association with the standard CGM output.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2022
Actual
7/03/2023
Date of last participant enrolment
Anticipated
27/02/2023
Actual
31/03/2023
Date of last data collection
Anticipated
24/02/2025
Actual
11/04/2024
Sample size
Target
60
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21797 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 36855 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 310843 0
Hospital
Name [1] 310843 0
Royal Prince Alfred Hospital
Country [1] 310843 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 312098 0
None
Name [1] 312098 0
Address [1] 312098 0
Country [1] 312098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310408 0
Sydney Local Health District Ethics Review Committee( RPAH Zone)
Ethics committee address [1] 310408 0
Ethics committee country [1] 310408 0
Australia
Date submitted for ethics approval [1] 310408 0
16/02/2022
Approval date [1] 310408 0
17/02/2022
Ethics approval number [1] 310408 0
2021/ETH1217

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

Contacts
Principal investigator
Name 117558 0
Dr Sheila Sivam
Address 117558 0
RPAH
Department of Respiratory Medicine
Missenden Rd
Camperdown NSW 2050
Country 117558 0
Australia
Phone 117558 0
+61 02 9515 8167
Fax 117558 0
Email 117558 0
sheila.sivam@health.nsw.gov.au
Contact person for public queries
Name 117559 0
Sheila Sivam
Address 117559 0
RPAH
Department of Respiratory Medicine
Missenden Rd
Camperdown NSW 2050
Country 117559 0
Australia
Phone 117559 0
+61 02 9515 8167
Fax 117559 0
Email 117559 0
sheila.sivam@health.nsw.gov.au
Contact person for scientific queries
Name 117560 0
Sheila Sivam
Address 117560 0
RPAH
Department of Respiratory Medicine
Missenden Rd
Camperdown NSW 2050
Country 117560 0
Australia
Phone 117560 0
+61 0295158167
Fax 117560 0
Email 117560 0
sheila.sivam@health.nsw.gov.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15184Study protocol    383625-(Uploaded-25-02-2022-16-44-28)-Study-related document.pdf



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.