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

Not Applicable

• Conditions: Diabetic foot ulcer; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN16000053
• Lead Sponsor: niversity of Leicester

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-16
• Last Update Posted: 9 September 2024
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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 in the study

Previous inclusion criteria:
1. Actively receiving DFU treatment
2. > = 18 to < = 75 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 in the study

Exclusion Criteria

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 activities
3. Under weight or with a Body Mass Index of < = 18.5 kg/m2
4. 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 involvement
6. Unable to communicate in written or verbal English
7. 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardio-respiratory fitness measured via a maximal incremental exercise test and quantified by the maximal amount of oxygen consumed and utilised (VO2 peak) pre and post the 12-week intervention (baseline and follow-up)