None listed
Conditions
Brief summary
Leg ulcers are costly, debilitating condition with few effective treatments. Compression bandaging helps healing, but about 4 out of every 10 people with a leg ulcer remain unhealed after 3 months. Recurrence occurs in up to 70% of people. Calf muscle function is poorer in people with venous leg ulcers than in people without such ulcers. Simple, easy and quickly completed home-based exercises can improve calf muscle function in people with venous ulcers, but it is not known what effect they have on ulcer healing. Current treatment for venous ulcers is compression bandaging. Participants in this pilot study will be randomised to receive the exercises + compression, or compression alone. The exercises are heel raises, and progress will be assessed every 3 weeks for the 12 week treatment period. This pilot study aims to test the acceptability, tolerability and efficacy of the home-based exercises on calf muscle function and provide information for the feasibility of a larger trial.
Interventions
Intervention: 12 week programme of three sets of heel raises every alternate day in addition to compression therapy. The maximum number of heel raises will be assessed at baseline, 3 weeks, 6 weeks and 9 weeks, with the number of heel raises per set to be set at 80% of the maximum (up to a maximum of 10) raises per set. Each set of heel raises will take approximately 1-2 minutes and the participant will complete 3 sets.
Both intervention and control participants will receive compression thera
Intervention: 12 week programme of three sets of heel raises every alternate day in addition to compression therapy. The maximum number of heel raises will be assessed at baseline, 3 weeks, 6 weeks and 9 weeks, with the number of heel raises per set to be set at 80% of the maximum (up to a maximum of 10) raises per set. Each set of heel raises will take approximately 1-2 minutes and the participant will complete 3 sets. Both intervention and control participants will receive compression therapy, either compression bandages or compression stockings. The choice of compression will be determined by participant and/or clinical preference.
Sponsors
Principal investigator (Andrew Jull)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Community-based diagnosis of venous ulceration based on case definition of clinical presentation, absence of other causative diseases and ankle-brachial index greater than 0.8; able to be treated with compression therapy; able to give informed consent; and able to perform at least one heel raise.mmunity-based diagnosis of venous ulceration based on case definition of clinical presentation, absence of other causative diseases and ankle-brachial index greater than 0.8; able to be treated with compression therapy; able to give informed consent; and able to perform at least one heel raise.
Exclusion criteria
History of rheumatoid arthritis; exercise intervention contraindicated by unstable medical condition such as heart failure.
Outcome results
None listed