Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients
2 other identifiers
interventional
180
1 country
11
Brief Summary
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:
- compliance with compression therapy and exercise levels
- time to leg ulcer recurrence
- cost effectiveness from a social perspective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFebruary 9, 2010
August 1, 2007
3.3 years
September 12, 2005
February 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
* Compliance with compression therapy
18 months
* Compliance with exercise prescriptions
18 months
* Leg ulcer recurrence
18 months
Secondary Outcomes (2)
* 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
Study Arms (2)
Lifestyle counseling
ACTIVE COMPARATORPatients receiving lifestyle counseling
Regular care
NO INTERVENTIONPatients receiving regular care
Interventions
Eligibility Criteria
You may qualify if:
- Venous insufficiency
- Venous and arterial insufficiency
You may not qualify if:
- Total immobility
- Insufficient mental capacity
- Insufficient comprehension of the dutch language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Slingeland ziekenhuis
Doetinchem, Gelderland, 7009BL, Netherlands
Radboud University Nijmegen Medical Center
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
Related Publications (7)
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.
PMID: 15009338BACKGROUNDPersoon 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.
PMID: 15009337BACKGROUNDBartholomew 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.
PMID: 9768376BACKGROUNDHarper 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.
PMID: 9616028BACKGROUNDKan 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.
PMID: 11735861BACKGROUNDNelson 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.
PMID: 11034749BACKGROUNDYang 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.
PMID: 10201775BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Theo van Achterberg, RN, PhD
IQ healthcare, Scientific Institute for Quality of healthcare, Radboud University Medical Centre, Nijmegen, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
January 1, 2005
Primary Completion
May 1, 2008
Study Completion
December 1, 2008
Last Updated
February 9, 2010
Record last verified: 2007-08