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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Matthew McCarthy
+44 (0)116 258 4323
mm636@le.ac.uk


Study Location:

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Be Part of Research - Trial Details - The health impacts of seated arm ergometry training in diabetic foot ulcer patients

The health impacts of seated arm ergometry training in diabetic foot ulcer patients

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Diabetic foot ulcer


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The main focus of this research concerns diabetic foot ulcers. The raised blood sugar levels of those with diabetes can cause nerve damage and loss of sensation in the feet. This allows ‘painless’ wounds to go unnoticed and get worse over time. Raised blood sugar levels can also lead to the narrowing of vessels and reduced blood flow to the feet. Loss of foot sensation and reduced blood flow can leave a person with diabetes vulnerable to developing patches of broken skin under the foot that are difficult to heal, known as diabetic foot ulcers. Doctors advise people with diabetic foot ulcers to stay off their feet as much as possible to help heal an ulcer. This often leads to high amounts of sitting time and reduced time spent being physically active which can further worsen their health over time. Keeping diabetic foot ulcer patients physically active while remaining off their feet is an area of research that is yet to be explored. The aim of this study is to investigate whether 12 weeks of seated upper-body exercise training using an arm ergometer (for a minimum of 30 minutes, three times per week) can improve fitness, health, quality of life, physical function, body composition and ulcer area in this population.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2019 01 Nov 2024

Publications

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32565482/ protocol (added 16/02/2021)

Participants are randomly allocated to the intervention group or the control group. The intervention group undertake seated arm ergometry training where they exercise at a moderate intensity 3 times per week for 12 weeks. Meanwhile, participants allocated to the control group continue to receive standard care as usual without an arm ergometry exercise training intervention. The change in fitness before and after the intervention period will be compared between the two groups.


Patients aged 18 to 75 who are receiving DFU treatment

You can take part if:


Current inclusion criteria as of 03/05/2023:
1. Actively receiving or has received DFU treatment within the previous 12 months
2. Aged > = 18 years of age
3. Able to undertake upper body arm exercise (specifically arm ergometry)
4. Deemed safe to exercise further to cardiac nurse evaluation at baseline
5. Participant is willing to give informed consent to take part


You may not be able to take part if:


1. Uncontrolled hyperglycaemia (HbA1c > 10% - Confirmed through baseline blood sample results)2. Report taking part in regular (at least once a week) strenuous sport or activities3. Under weight or with a Body Mass Index of < = 18.5 kg/m24. Existing heart problem (a cardiovascular event within the last 12 months or screened by cardiac nurse at baseline)5. Co-morbidity that the research team consider to be a contraindication to their study involvement6. Unable to communicate in written or verbal English7. Unable to provide written informed consent

* In the circumstance that an individual is not sure whether they meet the necessary criteria, they will be reviewed by a medic (named on the delegation log) for a clinical decision to be made during their baseline visit (prior to engaging in any study-related tasks)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospitals of Leicester NHS Trust
    Leicester Royal Infirmary Infirmary Square
    Leicester
    LE1 5WW

The assessment visits will provide participants with a unique insight into their health and fitness, something that would be expensive if done privately. Those allocated to the exercise intervention group will also have an exercise programme independently tailored to their needs by an exercise physiologist, something that would also be expensive if done privately. With any exercise programme, there is a slight increased risk of a heart event or injury, but this risk will be minimised through a detailed assessment of heart rhythm and electrical activity by a cardiac nurse during the first assessment visit. Target heart rates set by the exercise physiologist before each exercise session will be aimed at a ‘moderate’ intensity, ensuring that ‘overexertion’ does not occur, limiting the risk of injury. A 5-minute warm-up and cool-down period will also be done before and after each exercise session to facilitate further risk reduction of injury.

Dr Matthew McCarthy
+44 (0)116 258 4323
mm636@le.ac.uk



The study is sponsored by University of Leicester and funded by Diabetes UK; Grant Codes: 18/0005883,; Novo Nordisk UK Research Foundation; Grant Codes: RM65G0161.





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Read full details for Trial ID: ISRCTN16000053

Or CPMS: 42904

Last updated 14 October 2024

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