Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000885796
Ethics application status
Approved
Date submitted
14/06/2022
Date registered
22/06/2022
Date last updated
6/06/2024
Date data sharing statement initially provided
22/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of 12 Weeks of Upper Body Ergometry and Resistance Exercise in People with Diabetes-Related Foot Ulcers: The DFUEx Study
Scientific title
The Effects of 12 Weeks of Upper Body Ergometry and Resistance Exercise on Cardiorespiratory Fitness in People with Diabetes-Related Foot Ulcers: The DFUEx Study
Secondary ID [1] 307346 0
Nil
Universal Trial Number (UTN)
Trial acronym
DFU-Ex
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic foot ulcers 326638 0
Condition category
Condition code
Metabolic and Endocrine 323881 323881 0 0
Diabetes
Skin 323922 323922 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised Exercise Intervention: Those participants randomised to the exercise arm will undertake 12 weeks of upper limb cycle ergometry (UCE) and resistance training for supervised three times weekly exercise in small groups. An Accredited Exercise Physiologist (AEP) will undertake all exercise testing and supervision. Initially, UCE will commence at 60% VO2peak and progress to 70-80% over 2 weeks or as tolerated. UCE exercise duration will progress from 15 to 30 mins three times each week. Following UCE, resistance exercise of approximately 30 mins will be carried out in the same session. Resistance exercise will commence at 60% of 1 repetition maximum (1RM) for 2 sets of 8-12 repetitions and progress to 80% of 1RM by week 2 or as tolerated. Upper limb exercises include chest press, lat pulldown, seated row and tricep pushdown. Lower limb open chain exercises include knee extension, hamstring curl and hip extension. After 12 weeks, follow-up measures will be undertaken as per baseline data-collection. Supervised exercise sessions will be carried out at the Charles Perkins Royal Prince Alfred (CPC RPA) Clinic located next to Royal Prince Alfred Hospital (RPAH).
Intervention code [1] 323776 0
Lifestyle
Intervention code [2] 323814 0
Treatment: Other
Comparator / control treatment
Unsupervised Stretching and Usual Care Control Group: Study participants randomised to usual care with unsupervised stretching will be educated in avoiding weight-bearing exercise as per current physical activity recommendations for patients with an active Diabetic Foot Ulcer (DFU), as per Diabetes Feet Australia 2021 guidelines. Participants will be required to undertake 12 weeks of unsupervised stretching (3 times per week for 15 mins) following a demonstration of the stretches with an AEP. Additionally, participants randomised to this group will receive familiarisation sessions on the upper limb ergometer every 3 weeks at the CPC RPA clinic gym. After 12 weeks, follow-up measures will be undertaken as per baseline data-collection. Familiarisation sessions will be carried out at the Charles Perkins Royal Prince Alfred Clinic located next to RPAH. Adherence to the Unsupervised Stretching and Usual Care Control intervention will not be measured.
Control group
Active

Outcomes
Primary outcome [1] 331691 0
The mean difference of the change in cardiorespiratory fitness as quantified by VO2peak (UCE with gas exchange) testing between exercise and control
Timepoint [1] 331691 0
12 weeks after commencing the intervention
Secondary outcome [1] 410798 0
Upper body strength as measured by 1-RM strength test
Timepoint [1] 410798 0
12 weeks after commencing the intervention.
Secondary outcome [2] 410799 0
percentage of people healed at follow-up (via clinical assessment acetate tracing)
Timepoint [2] 410799 0
12 weeks after commencing the intervention.
Secondary outcome [3] 410800 0
ankle brachial index via doppler
Timepoint [3] 410800 0
12 weeks after commencing the intervnetion
Secondary outcome [4] 410801 0
Blood lipids
Timepoint [4] 410801 0
12 weeks after commencing the intervention.
Secondary outcome [5] 410802 0
Urine creatinine
Timepoint [5] 410802 0
12 weeks after commencing the intervention.
Secondary outcome [6] 410803 0
Body mass index (BMI), height determined by stadiometer and weight determined using balance scales
Timepoint [6] 410803 0
12 weeks after commencing the intervention.
Secondary outcome [7] 410804 0
assessment of quality of life via AQOL-8d
Timepoint [7] 410804 0
12 weeks after commencing the intervention.
Secondary outcome [8] 410805 0
Arterial stiffness determined using a composite of central blood pressure and wave reflection characteristics measured via sphygmocore
Timepoint [8] 410805 0
12 weeks after commencing the intervention.
Secondary outcome [9] 410806 0
wound fluid markers of healing (point of care mmp-9 test)
Timepoint [9] 410806 0
12 weeks after commencing the intervention.
Secondary outcome [10] 410807 0
White blood cell immunophenotyping via mass cytometery
Timepoint [10] 410807 0
12 weeks after commencing the intervention.
Secondary outcome [11] 410808 0
Qualitative assessment of participants experience as 10 minute semi-structured, face-to-face/or virtual, one-on-one interview with a member of the research team
Timepoint [11] 410808 0
12 weeks after commencing the intervention.
Secondary outcome [12] 410915 0
lower body strength as measured by 1-RM strength test
Timepoint [12] 410915 0
12 weeks after commencing the intervention.
Secondary outcome [13] 410916 0
percentage wound closure using acetate tracing
Timepoint [13] 410916 0
12 weeks after commencing the intervention
Secondary outcome [14] 410917 0
foot sensory testing via monofilament testing
Timepoint [14] 410917 0
12 weeks after commencing the intervention
Secondary outcome [15] 410918 0
fasting blood plasma glucose.
Timepoint [15] 410918 0
12 weeks after commencing the intervention
Secondary outcome [16] 410921 0
urine microalbumin
Timepoint [16] 410921 0
12 weeks after commencing the intervention
Secondary outcome [17] 410922 0
Body composition as determined by Dual Energy X-Ray Absorpiometry
Timepoint [17] 410922 0
12 weeks after commencement of the intervention
Secondary outcome [18] 410923 0
self efficacy for exercise as measured via SEE questionnaire
Timepoint [18] 410923 0
12 weeks after commencing the intervention
Secondary outcome [19] 411051 0
blood fasting insulin
Timepoint [19] 411051 0
12 weeks after commencing the intervention
Secondary outcome [20] 411052 0
waist circumference via tape measure at waist
Timepoint [20] 411052 0
12 weeks after commencing the intervention
Secondary outcome [21] 411054 0
full blood count
Timepoint [21] 411054 0
12 weeks are commencing intervention

Eligibility
Key inclusion criteria
1. 18-70 years of age.
2. Have confirmed diabetes mellitus (HbA1c equal to or greater than6.5%).
3. Foot ulcer of greater than 4 weeks duration.
4. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or breastfeeding.
2. Underlying osteomyelitis.
3. Severe peripheral artery disease (Arterial Brachial Index equal to or greater than 0.7).
4. Severe infection (WIFI Criteria).
5. Uncontrolled psychiatric illness.
6. Recent onset cardiovascular disease (coronary artery disease, myocardial infarction, etc, within 6 months).
7. Musculoskeletal pathology that would impede capacity to carry out the exercise assessments and intervention.
8. Participants who are not fluent in English or who have difficulty understanding English

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
total n = 32 (16 intervention, 16 control) study participants are required for 80% power to detect a 3.5mL/kg/min difference in VO2 peak (primary outcome) from baseline to 12 weeks (alpha 5%, standard deviation of 3.5mL/kg/min). This includes a 10% drop-out, factored into an intention to treat analysis. A 3.5mL/kg/min increase in VO2peak is associated with clinically relevant reduction in all-cause mortality. A post-hoc analysis will separately be undertaken for study participant who adhere to at least 80% of their exercise regimen.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
5/06/2023
Date of last participant enrolment
Anticipated
21/05/2024
Actual
Date of last data collection
Anticipated
29/07/2024
Actual
Sample size
Target
32
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37802 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311315 0
Other
Name [1] 311315 0
Exercise and Sports Science Australia
Country [1] 311315 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 312686 0
None
Name [1] 312686 0
Address [1] 312686 0
Country [1] 312686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310818 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310818 0
Ethics committee country [1] 310818 0
Australia
Date submitted for ethics approval [1] 310818 0
09/05/2022
Approval date [1] 310818 0
09/02/2023
Ethics approval number [1] 310818 0
2022/ETH00980

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

Contacts
Principal investigator
Name 118970 0
A/Prof Nathan Johnson
Address 118970 0
Level 6, Charles Perkins Centre
John Hopkins Drive
The University of Sydney, NSW 2006
Country 118970 0
Australia
Phone 118970 0
+61 2 93519137
Fax 118970 0
Email 118970 0
[email protected]
Contact person for public queries
Name 118971 0
Callum Baker
Address 118971 0
The University of Sydney
Level 3W, Charles Perkins Centre - D17
The University of Sydney NSW 2006
Country 118971 0
Australia
Phone 118971 0
+61 2 8627 1927
Fax 118971 0
Email 118971 0
[email protected]
Contact person for scientific queries
Name 118972 0
Callum Baker
Address 118972 0
The University of Sydney
Level 3W, Charles Perkins Centre - D17
The University of Sydney NSW 2006
Country 118972 0
Australia
Phone 118972 0
+61 2 8627 1927
Fax 118972 0
Email 118972 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
No additional documents have been identified.