The Lively Legs self-management programme increased physical activity and reduced wound days in leg ulcer patients: Results from a randomized controlled trial

Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, The Netherlands.
International journal of nursing studies (Impact Factor: 2.9). 09/2011; 49(2):151-61. DOI: 10.1016/j.ijnurstu.2011.09.005
Source: PubMed


Investigating the effectiveness of the Lively Legs program for promoting adherence with ambulant compression therapy and physical exercise as well as effects on leg ulcer recurrence.
A randomized controlled trial.
Eleven outpatient clinics for dermatology in the Netherlands participated in the study.
184 patients attending the outpatient clinic with leg ulcers based dominantly on a venous aetiology. Randomization was stratified by centre, age, sex and aetiology (purely venous or mixed).
The intervention group received additionally to usual care, lifestyle counselling according to the Lively Legs program, the control group received care as usual. Patient behaviour on physical activity (IPAQ), adherence to compression therapy and wound status were assessed every 6 months during a follow-up period of 18 months. Data analysis was based on the intention to treat principle, using a generalized linear model with additive link function and Bernouilli distributions. Effects on recurrence were analyzed after the first ulcer had healed using proportional hazard regression.
The results showed an increase in adherence with compression therapy in both groups, with no significant difference between the groups. The intervention group performed significantly better on conducting leg exercises (p<0.01) and 10 min walks at five days a week (p<0.01). There was no difference on reaching 30 min of walking on 5 days a week. The intervention group had less wound days (p<0.01), time till recurrence did not differ significantly (p=0.07).
The Lively Legs program effectively increased the use of leg exercises and walking behaviour, and decreased wound time, however it did not significantly enhance use of compression stockings. Non significant effects regarding secondary outcomes may relate to the frailty of the sample.

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Available from: Rob A B Oostendorp, Oct 04, 2015
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    • "Furthermore, nearly half of the patients report insufficient levels of physical activity [6]. Although patients’ problems appear to be lifestyle related, advice to improve physical activity levels through adequate walking behaviour and leg exercises is not part of common wound management practice [7]. "
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    ABSTRACT: Background Exercise and adequate self-management capacity may be important strategies in the management of venous leg ulcers. However, it remains unclear if exercise improves the healing rates of venous leg ulcers and if a self-management exercise program based on self-efficacy theory is well adhered to. Method/design This is a randomised controlled in adults with venous leg ulcers to determine the effectiveness of a self-efficacy based exercise intervention. Participants with venous leg ulcers are recruited from 3 clinical sites in Australia. After collection of baseline data, participants are randomised to either an intervention group or control group. The control group receive usual care, as recommended by evidence based guidelines. The intervention group receive an individualised program of calf muscle exercises and walking. The twelve week exercise program integrates multiple elements, including up to six telephone delivered behavioural coaching and goal setting sessions, supported by written materials, a pedometer and two follow-up booster calls if required. Participants are encouraged to seek social support among their friends, self-monitor their weekly steps and lower limb exercises. The control group are supported by a generic information sheet that the intervention group also receive encouraging lower limb exercises, a pedometer for self-management and phone calls at the same time points as the intervention group. The primary outcome is the healing rates of venous leg ulcers which are assessed at fortnightly clinic appointments. Secondary outcomes, assessed at baseline and 12 weeks: functional ability (range of ankle motion and Tinetti gait and balance score), quality of life and self-management scores. Discussion This study seeks to address a significant gap in current wound management practice by providing evidence for the effectiveness of a home-based exercise program for adults with venous leg ulcers. Theory-driven, evidence-based strategies that can improve an individual’s exercise self-efficacy and self-management capacity could have a significant impact in improving the management of people with venous leg ulcers. Information gained from this study will provide much needed information on management of this chronic disease to promote health and independence in this population. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000475842.
    BMC Dermatology 10/2014; 14(1):16. DOI:10.1186/1471-5945-14-16
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    • "The effectiveness of the Lively Legs program on behavior change was established in a multicenter randomized controlled trial [18]. Results of this study showed that the intervention group performed better on conducting leg exercises and 10-minute walks five days a week. "
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    ABSTRACT: Background Implementation of lifestyle interventions in patient care is a major challenge. Understanding factors that influence implementation is a first step in programs to enhance uptake of these interventions. A lifestyle-counseling intervention, Lively Legs, delivered by trained nurses, can effectively improve the lifestyle in patients with venous leg ulcers. The aim of this study was to identify factors that hindered or facilitated implementation of this intervention in outpatient dermatology clinics and in home care. Methods A mixed-methods multiple case study in five purposefully selected healthcare settings in the Netherlands was conducted. Measurements to identify influencing factors before and after implementation of Lively Legs included interviews, focus groups, questionnaires, and nurses’ registration. Analyses focused on qualitative data as the main data source. All data were compared across multiple cases to draw conclusions from the study as a whole. Results A total of 53 patients enrolled in the Lively Legs program, which was delivered by 12 trained nurses. Barriers for implementation were mainly organizational. It was difficult to effectively organize reaching and recruiting patients for the program, especially in home care. Main barriers were a lack of a standardized healthcare delivery process, insufficient nursing time, and a lack of motivated nurses to deliver the program. Facilitating factors were nurse-driven coordination of care and a standardized care process to tie Lively Legs into, as this resulted in better patient recruitment and better program implementation. Conclusions This study identified a range of factors influencing the implementation of a lifestyle-counseling program, mainly related to the organization of healthcare. Using a case study method proved valuable in obtaining insight into influencing factors for implementation. This study also shed light on a more general issue, which is that leg ulcer care is often fragmented, indicating that quality improvement is needed.
    Implementation Science 10/2012; 7(1):104. DOI:10.1186/1748-5908-7-104 · 4.12 Impact Factor
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    ABSTRACT: This study aimed to assess the feasibility of a home-based exercise programme and examine the effects on the healing rates of venous leg ulcers. A 12-week randomised controlled trial was conducted investigating the effects of an exercise intervention compared to a usual care group. Participants in both groups (n = 13) had active venous ulceration and were treated in a metropolitan hospital outpatients clinic in Australia. Data were collected on recruitment from medical records, clinical assessment and questionnaires. Follow-up data on progress in healing and treatments were collected fortnightly for 12 weeks. Calf muscle pump function data were collected at baseline and 12 weeks from recruitment. Range of ankle motion data were collected at baseline, 6 and 12 weeks from recruitment. This pilot study indicated that the intervention was feasible. Clinical significance was observed in the intervention group with a 32% greater decrease in ulcer size (P = 0·34) than the usual care group, and a 10% (P = 0·74) improvement in the number of participants healed in the intervention group compared to the usual care group. Significant differences between groups over time were observed in calf muscle pump function parameters [ejection fraction (P = 0·05), residual volume fraction (P = 0·04)] and range of ankle motion (P = 0·01). This pilot study is one of the first studies to examine and measure clinical healing rates for participants involved in a home-based progressive resistance exercise programme. Further research is warranted with a larger multi-site study.
    International Wound Journal 06/2012; 10(4). DOI:10.1111/j.1742-481X.2012.00995.x · 2.15 Impact Factor
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