Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001370796
Ethics application status
Approved
Date submitted
18/10/2022
Date registered
26/10/2022
Date last updated
26/10/2022
Date data sharing statement initially provided
26/10/2022
Date results provided
26/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise for adults with diabetes related foot ulcers.
Scientific title
Exercise in adults admitted to hospital with diabetes-related foot ulcers: a pilot study of feasibility and safety
Secondary ID [1] 308203 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 327951 0
Foot ulcer 327952 0
Condition category
Condition code
Metabolic and Endocrine 325017 325017 0 0
Diabetes
Skin 325064 325064 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study was one session of supervised aerobic and resistance exercise in the hospital inpatient setting during admission. Exercise was supervised by a Physiotherapist.

The exercise session was up to 40mins in duration, consisting of an aerobic exercise and resistance exercise component.

Aerobic exercise up to 20 mins dependent upon participant tolerance. Exercise was completed using upper limb ergometry, single or double leg cycling or treadmill walking dependent upon which exercise was able to be compliant with weight bearing status.

Resistance exercise up to 20 mins: total of 2-3 sets of 8-15 repetitions of each exercise. Exercises were selected from the following list dependent on the patient's weight bearing status and tolerance ; bicep curl, shoulder press, deltoid fly, seated or bent over row, leg press, sit to stands, squats, bridging, heel raise, side lying or standing hip abduction and seated knee extensions.

Participants were instructed to work to a moderate intensity on the BORG Category-Ratio scale of perceived effort (CR-10) and exercise was prescribed to achieve this intensity.

On hospital discharge, an individually prescribed home exercise programme was provided and consisted of a selection of pre-determined exercises similar to those utilised in the inpatient session. This exercise programme was 20 minutes in duration. Participants were asked to complete this daily until follow up review 2 weeks after discharge from hospital. This home exercise programme was completed without supervision. A log book was provided to monitor compliance.
Intervention code [1] 324659 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332837 0
Recruitment assessed as the number of participants enrolled in the project as a proportion of all eligible participants approached for consent as per audit of enrolment log (50% patient recruitment will be considered feasible).
Timepoint [1] 332837 0
At conclusion of the study
Primary outcome [2] 332838 0
Safety as assessed by the number of adverse events which will be recorded by the research Physiotherapist, or reviewed in the clinical documentation retrospectively.

Adverse Events for this study are defined as:
- Low blood glucose / hypoglycaemia during exercise
- Any event related to the exercise session which requires a referral for an unplanned medical review.
Timepoint [2] 332838 0
2 weeks after hospital discharge
Primary outcome [3] 332892 0
Retention assessed as the number of participants who withdrew from the project, 75% will be determined as feasible. Attendance logs & withdrawal request forms will be audited.
Timepoint [3] 332892 0
2 weeks after hospital discharge
Secondary outcome [1] 414823 0
Physical Activity measured using International Physical Activity Questionnaire
Timepoint [1] 414823 0
2 weeks after hospital discharge
Secondary outcome [2] 414824 0
Grip Strength measured with Jamar dynamometer
Timepoint [2] 414824 0
2 weeks after hospital discharge
Secondary outcome [3] 414825 0
Perceived barriers to exercise assessed using the Exercise Benefits/Barriers Scale survey
Timepoint [3] 414825 0
2 weeks after hospital discharge
Secondary outcome [4] 414826 0
Exercise load measured using the Borg CR-10 scale & session RPE
Timepoint [4] 414826 0
During in hospital exercise session
Secondary outcome [5] 414827 0
Satisfaction of exercise session measured using likert scale survey
Timepoint [5] 414827 0
2 weeks after hospital discharge
Secondary outcome [6] 415000 0
*Additional Primary Outcome*
Adherence, assessed as the number of participants who completed both inpatient and outpatient phases of the project. This study will accept 75% retention as feasible. Audit of attendance logs and log books will be completed.
Timepoint [6] 415000 0
2 weeks after hospital discharge.

Eligibility
Key inclusion criteria
1. Over the age of 18
2. Had a diagnosis of diabetes mellitus
3. Currently admitted to hospital with a Diabetes related foot ulcer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. unable to consent due to language or cognitive impairment
2. acute myocardial infarction
3. unstable angina
4. severe heart failure (New York Heart Association Functional Classification IV)
5. cardiac arrhythmias causing haemodynamic compromise
6. musculoskeletal or neurological conditions precluding exercise
7. otherwise determined not to be in their best interest to participate

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a pilot study with a single group, comparative analyses between groups will not be required. We will apply standard descriptive statistical tests to the quantitative data relating to primary and secondary outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/10/2020
Date of last participant enrolment
Anticipated
Actual
16/03/2021
Date of last data collection
Anticipated
Actual
30/03/2021
Sample size
Target
30
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23379 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 38776 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 312460 0
Government body
Name [1] 312460 0
Chief Allied Health Office, Department of Health Western Australia
Country [1] 312460 0
Australia
Primary sponsor type
Individual
Name
Paul Gittings
Address
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
Western Australia
6150
Country
Australia
Secondary sponsor category [1] 314041 0
None
Name [1] 314041 0
Address [1] 314041 0
Country [1] 314041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311805 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 311805 0
Ethics committee country [1] 311805 0
Australia
Date submitted for ethics approval [1] 311805 0
Approval date [1] 311805 0
30/09/2020
Ethics approval number [1] 311805 0
RGS

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

Contacts
Principal investigator
Name 122426 0
Dr Paul Gittings
Address 122426 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
WA
6150
Country 122426 0
Australia
Phone 122426 0
+61 08 61528862
Fax 122426 0
Email 122426 0
[email protected]
Contact person for public queries
Name 122427 0
Paul Gittings
Address 122427 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
WA
6150
Country 122427 0
Australia
Phone 122427 0
+61 08 61528862
Fax 122427 0
Email 122427 0
[email protected]
Contact person for scientific queries
Name 122428 0
Paul Gittings
Address 122428 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
WA
6150
Country 122428 0
Australia
Phone 122428 0
+61 08 615228862
Fax 122428 0
Email 122428 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
Data will be entered electronically into RedCAP electronic data capture tool hosted by the Department of Health. Only the study team will have access to this database and access will be regulated by the CPI.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17391Study protocol  [email protected]
17392Informed consent form  [email protected]



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.