Venous leg ulcers Circulatory System
Conditions
Interventions
Current intervention as of 14/07/2022:
Following baseline measurements, participants (n=40) will be randomised remotely to one of the two study groups (Group A: home-based exercise with embedded behav
Group B: standard care only, n=20) by the study statistician (to ensure allocation concealment), using a computer programme (nQuery Advisor 6.0, Statistical Solutions, Ireland) to generate stratified
Sponsors
Sheffield Health & Social Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are at least 18 years of age 2. Have at least one venous leg ulcer of primarily venous aetiology (determined by a clinician) with a maximum diameter = 1 cm 3. Have an ankle brachial pressure index (ABPI) = 0.8 (recorded within the previous 3 months) 4. Are able/willing to tolerate lower-limb compression
Exclusion criteria
Exclusion criteria: 1. Are unsuitable/unable to exercise (determined by a clinician at screening or baseline) 2. Are unable/unwilling to tolerate lower-limb compression 3. Have insulin-controlled diabetes mellitus 4. Are pregnant 5. Have coexisting skin conditions, vasculitis, deep venous occlusion or malignant/atypical ulceration (if suitable otherwise, participants may be re-considered at a later stage) 6. Require major surgery within 3 months from eligibility assessment 7. Have a leg ulcer with a maximum diameter =1 cm 8. Have had an ulcer at the same site within the previous 3 months 9. Are unable or do not wish to consent to participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rates measured as rate of invited participants who are eligible and consenting and reported in Consolidated Standards of Reporting Trials (CONSORT) flowchart 2. Acceptability of procedures assessed by examining reasons for drop-out in discontinuing participants and comparing attrition between groups 3. Suitability of measurement procedures evaluated by completion rates and reasons for missing data 4. Attrition rates established as discontinuation of intervention and loss to follow-up measurement 5. The acceptability of the exercise programme assessed by using session compliance data and participant feedback via one-to-one, semi-structured interviews conducted after the 3-month follow-up visit 6. Exercise safety assessed by exploring reasons for drop-out from the intervention and the number and type of adverse events that occur in each group 7. Group contamination assessed by the number of people in the control group who take up exercise as a result of their study participation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life assessed using EQ-5D-5L and VEINES-QOL at baseline and at 3 and 6 months 2. Physical fitness assessed using Senior Fitness Test at baseline and at 3 and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed