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

Leg Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184873
• Other study ID #: 13091966
• Secondary ID: ZonMw 945-04-058
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: February 8, 2010
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2007
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Leg Ulcer
• Leg Ulcers
• Ulcer
• Varicose Ulcer
• Varicose Ulcers

Intervention

Behavioral:
• Health Counseling

Locations

Country	Name	City	State
Netherlands	IJssellandziekenhuis	Capelle A/d IJssel	Zuid Holland
Netherlands	Jeroen Bosch ziekenhuis	Den Bosch	Noord Brabant
Netherlands	Elkerliek ziekenhuis	Deurne	Noord Brabant
Netherlands	Slingeland ziekenhuis	Doetinchem	Gelderland
Netherlands	St Anna ziekenhuis	Geldrop	Noord Brabant
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland
Netherlands	ErasmusMC	Rotterdam	Zuide Holland
Netherlands	Ziekenhuis Rivierenland	Tiel	Gelderland
Netherlands	University Medical Center Utrecht	Utrecht
Netherlands	Bernhoven ziekenhuis	Veghel	Noord Brabant
Netherlands	Vie Curi	Venlo / Venray	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Nelson EA, Bell-Syer SE, Cullum NA. Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev. 2000;(4):CD002303. Review. Update in: Cochrane Database Syst Rev. 2012;8:CD002303. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	* Compliance with compression therapy		18 months	No
Primary	* Compliance with exercise prescriptions		18 months	No
Primary	* Leg ulcer recurrence		18 months	No
Secondary	* time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods		18 months	No
Secondary	* evaluation of the cost effectiveness of the program		18 months	No