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| ID | Type | Description | Link |
|---|---|---|---|
| ZonMw 945-04-058 |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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Leg ulcers are often chronic or recurring complications of peripheral circulation disorders. Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in general. Especially exercise and compliance with compression therapy are key elements in the course of leg ulcer healing and recurrence. Yet many patients demonstrate sedentary lifestyles and non-compliance and current practice offers no systematic approach in the promotion of compliance and physical activity in these patients.
The purpose of the study is testing 'Lively Legs' a compliance promotion program for patients with leg ulcers. The study tests the program on effects regarding:
The project is a multi centre study, using a randomized controlled design. Patients in the study (n=380) are equally randomized to either the experimental or the control group. Patients in the intervention group receive counseling during a period of six months, in line with the Lively Legs program. Patients in the control group receive regular care. Recruitment takes place within a period of nine months. Data are collected at baseline, directly after the intervention period at 6 months, and at follow-ups at 12 and 18 months. Quality of life is additionally assessed at 3, 9 and 15 months.
The population for this study consists of leg ulcer patients, suffering from peripheral circulation disorders of venous or mixed (venous and arterial) origin. The population is restricted to patients treated at outpatient clinics for dermatology.
Individual counseling is performed by nurses, based on the Lively Legs lifestyle-program for leg ulcer patients. This evidence-based program was systematically developed using the Intervention Mapping framework, thus integrating scientific evidence, relevant theories and patient and care provider expertise. The program aims at improved compliance with compression therapy and prescribed exercise level in all patients.
Social Cognitive Theory provides the theoretical framework and the core methods for the Lively Legs program. Nurses will perform the central role as health counselor. In a maximum of six consultations, they will offer tailored counseling, including compliance and physical activity assessment, identification of relevant determinants of behavior, goal setting, and the application of methods and strategies from the Lively Legs program
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | Active Comparator | Patients receiving lifestyle counseling |
|
| Regular care | No Intervention | Patients receiving regular care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Counseling | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| * Compliance with compression therapy | 18 months | |
| * Compliance with exercise prescriptions | 18 months | |
| * Leg ulcer recurrence | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| * time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods | 18 months | |
| * evaluation of the cost effectiveness of the program | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theo van Achterberg, RN, PhD | IQ healthcare, Scientific Institute for Quality of healthcare, Radboud University Medical Centre, Nijmegen, The Netherlands | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slingeland ziekenhuis | Doetinchem | Gelderland | 7009BL | Netherlands | ||
| Radboud University Nijmegen Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15009338 | Background | Heinen MM, van Achterberg T, op Reimer WS, van de Kerkhof PC, de Laat E. Venous leg ulcer patients: a review of the literature on lifestyle and pain-related interventions. J Clin Nurs. 2004 Mar;13(3):355-66. doi: 10.1046/j.1365-2702.2003.00887.x. | |
| 15009337 | Background | Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof PC, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs. 2004 Mar;13(3):341-54. doi: 10.1046/j.1365-2702.2003.00859.x. |
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| Nijmegen |
| Gelderland |
| 6500 HB |
| Netherlands |
| Ziekenhuis Rivierenland | Tiel | Gelderland | 4002 WP | Netherlands |
| Vie Curi | Venlo / Venray | Limburg | 5900 BX | Netherlands |
| Jeroen Bosch ziekenhuis | 's-Hertogenbosch | North Brabant | 5323 GV | Netherlands |
| Elkerliek ziekenhuis | Deurne | North Brabant | 5751 CB | Netherlands |
| St Anna ziekenhuis | Geldrop | North Brabant | 5664EH | Netherlands |
| Bernhoven ziekenhuis | Veghel | North Brabant | 5461 AA | Netherlands |
| IJssellandziekenhuis | Capelle aan den IJssel | South Holland | 2906 ZC | Netherlands |
| University Medical Center Utrecht | Utrecht | Utrecht | 3584 CX | Netherlands |
| ErasmusMC | Rotterdam | Zuide Holland | 3015 GJ | Netherlands |
| 9768376 | Background | Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ Behav. 1998 Oct;25(5):545-63. doi: 10.1177/109019819802500502. |
| 9616028 | Background | Harper PL, Watson L, Bannon R. Compression ultrasonography for diagnosing deep vein thrombosis. Protocol is safe. BMJ. 1998 May 16;316(7143):1534; author reply 1535. No abstract available. |
| 11735861 | Background | Kan YM, Delis KT. Hemodynamic effects of supervised calf muscle exercise in patients with venous leg ulceration: a prospective controlled study. Arch Surg. 2001 Dec;136(12):1364-9. doi: 10.1001/archsurg.136.12.1364. |
| 11034749 | Background | Nelson EA, Bell-Syer SE, Cullum NA. Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev. 2000;(4):CD002303. doi: 10.1002/14651858.CD002303. |
| 10201775 | Background | Yang D, Vandongen YK, Stacey MC. Effect of exercise on calf muscle pump function in patients with chronic venous disease. Br J Surg. 1999 Mar;86(3):338-41. doi: 10.1046/j.1365-2168.1999.00993.x. |
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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