Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients

Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance With Compression Therapy and Prescribed Exercise in Leg Ulcer Patients

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcers; Varicose Ulcers
• Intervention / Treatment: Behavioral: Health Counseling

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • University Medical Center Utrecht
  • Gelderland
    • Doetinchem, Gelderland, Netherlands, 7009BL
      • Slingeland Ziekenhuis
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Center
    • Tiel, Gelderland, Netherlands, 4002 WP
      • Ziekenhuis Rivierenland
  • Limburg
    • Venlo / Venray, Limburg, Netherlands, 5900 BX
      • Vie Curi
  • Noord Brabant
    • Den Bosch, Noord Brabant, Netherlands, 5323 GV
      • Jeroen Bosch Ziekenhuis
    • Deurne, Noord Brabant, Netherlands, 5751 CB
      • Elkerliek Ziekenhuis
    • Geldrop, Noord Brabant, Netherlands, 5664EH
      • St Anna ziekenhuis
    • Veghel, Noord Brabant, Netherlands, 5461 AA
      • Bernhoven Ziekenhuis
  • Zuid Holland
    • Capelle A/d IJssel, Zuid Holland, Netherlands, 2906 ZC
      • IJssellandziekenhuis
  • Zuide Holland
    • Rotterdam, Zuide Holland, Netherlands, 3015 GJ
      • ErasmusMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Venous insufficiency
• Venous and arterial insufficiency
• Receiving treatment on outpatient clinics for dermatology at the moment of inclusion or in the past three months before inclusion

Exclusion Criteria:

• Total immobility
• Insufficient mental capacity
• Insufficient comprehension of the dutch language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lifestyle counseling; Patients receiving lifestyle counseling	Behavioral: Health Counseling
No Intervention: Regular care; Patients receiving regular care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
* Compliance with compression therapy	18 months
* Compliance with exercise prescriptions	18 months
* Leg ulcer recurrence	18 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Study Director: Theo van Achterberg, RN, PhD, IQ healthcare, Scientific Institute for Quality of healthcare, Radboud University Medical Centre, Nijmegen, The Netherlands

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): February 9, 2010
• Last Update Submitted That Met QC Criteria: February 8, 2010
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Keywords: randomized controlled trial; multi-center study; health-counseling
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 13091966; ZonMw 945-04-058