Background Lymphoedema is a chronic condition that causes swelling in the body tissues. Presently, there is no cure for lymphoedema; instead, current treatment is aimed at lifelong management to help control symptoms. Intermittent pneumatic compression (IPC) therapy can be considered as an adjunct to standard lymphoedema care; however, research regarding the efficacy of this treatment modality is limited. Methods Twenty participants were recruited from an outpatient lymphoedema clinic (South Wales, UK) to a feasibility randomised control trial designed to evaluate the efficacy of an IPC device (LymphAssist, Huntleigh Healthcare) in reducing lower limb volume. The primary objective was to assess feasibility in terms of (1) study feasibility, including recruitment, retention and assessment of outcome measures, and (2) intervention feasibility, including intervention fidelity and acceptability to participants. Participants were randomly assigned to a control group (n = 10) or intervention group (n = 10). The control group received their standard lymphoedema care only for a 6-month period, whereas the intervention group received their standard lymphoedema care plus an IPC device to use for 6 months. A bilateral lower limb assessment and quality of life survey were undertaken at baseline and 3- and 6-month time points. Results The study recruited to target within the planned time frame with a retention rate of 80%. Issues relating to potential recruitment bias and study attrition were identified and possible solutions explored. In addition, supplementary primary outcome measures that are important to the study population were identified and will be incorporated into the design of future studies. Conclusion This feasibility study identified that a larger randomised controlled trial investigating the efficacy of home use IPC devices is feasible with modifications to the study protocol. Trial registration This trial is registered with clinicaltrials.gov (NCT03825263).
Background: Recent advances in technology have allowed intermittent pneumatic compression (IPC) devices to develop so that their function mimics the process and principles of manual lymphatic drainage (MLD); however, research into the effectiveness of such devices is lacking. This study aimed to investigate the effectiveness of a patented IPC technique designed to mimic MLD (the LymphAssist), compared with a typical sequential IPC regimen. Methods and Results: Forty patients with a confirmed diagnosis of lower limb ISL (International Society of Lymphology) stage II or III lymphedema were recruited into this three-phased study. A bilateral leg volume assessment and quality-of-life assessment were completed at four clinic visits across the course of the study. The LymphAssist IPC regimen was significantly more effective in reducing distal leg volume than the sequential mode (mean volume reduction: 230 ± 135 mL vs. 140 ± 84 mL, respectively, p = 0.01). Improvements in leg volume were transient as both groups demonstrated a rebound or increase in volume during the washout period (LymphAssist: 238 ± 168 mL, sequential: 276 ± 158 mL, p = 0.3). Overall, IPC was effective in improving quality-of-life scores (mean reduction: 10 ± 11, p < 0.001). Conclusion: IPC is effective in reducing limb volume and improving quality of life for patients with lower limb lymphedema. IPC that mimics the MLD process has been shown to be more effective in reducing leg volume compared with traditional sequential IPC in the distal aspect of the leg. The increase in leg volume observed after discontinuation of IPC suggests that regular treatment is required to maintain its associated effects. Clinical Trial Registration Number: NTC 03856281.
Background:In adults ageing is accompanied by changes in limb volume and skin biomechanical properties.Objectives: To explore the relationship between body size, aging, skin biomechanics, and leg volume, V Leg and to define predictive equations linking leg volume with these properties.Methods: Sixty-two healthy adults (Age 18-80 years, M:F 45:55) were recruited.Anthropomorphic measures were recorded along with V Leg (via circumferential method) and skin tone, stiffness, and elastance (via tonometry). Regression analysis was performed to define relationship between the measured parameters. Results:In healthy adults bilateral V Leg were the same regardless of leg or sex, 5791 ± 1363 for females and 6151 ± 1203 mls for males. V Leg was positively correlated to body weight, where V Leg (mls) = 1058 + 69 × Wt (kg) for females and V Leg (mls) = 539 + 65 × Wt (Kg) of body weight for males. Skin surface biomechanical properties varied with sex, leg volume, and location on the leg with the malleolus exhibiting the stiffest surface. Conclusion:The study shows that anthropometric measures change with sex and leg size are multifactorial and body weight, sex, and skin condition as important determinant factors of leg volume.
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