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

Purpose

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.

Condition	Intervention
Leg Ulcers Varicose Ulcers	Behavioral: Health Counseling

MedlinePlus related topics:

Exercise and Physical Fitness Leg Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Radboud University:

Primary Outcome Measures:

PRIMARY
* Compliance with compression therapy
* Compliance with exercise presriptions
* Leg ulcer recurrence

Secondary Outcome Measures:

* time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods
* evaluation of the cost effectiveness of the program

Estimated Enrollment:	380
Study Start Date:	January 2005
Estimated Study Completion Date:	July 2007

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184873

Contacts


Contact: Maud Heinen, MSc	+31243619326	m.heinen@kwazo.umcn.nl

Contact: Theo Achterberg van, PhD	+3124369529	t.vanachterberg@kwazo.umcn.nl

Locations


Netherlands
	University Medical Center Utrecht	Recruiting
	Utrecht, Netherlands, 3584 CX
	Contact: Antoinette Scheerhoorn, Ba a.scheerhoorn@umcu.nl
	Sub-Investigator: Carin Smit, RN

Netherlands, Gelderland
	Radboud University Nijmegen Medical Center	Recruiting
	Nijmegen, Gelderland, Netherlands, 6500 HB
	Contact: Peter van de Kerkhof, MD / PhD p.vandekerkhof@derma.umcn.nl
	Sub-Investigator: Jolanda Zonnenberg, RN
	Slingeland ziekenhuis	Recruiting
	Doetinchem, Gelderland, Netherlands, 7009BL
	Contact: Dr. Sybrandy, PhD secretariaat.dermatologie@slingeland.nl
	Sub-Investigator: Margre Wentink
	Ziekenhuis Rivierenland	Recruiting
	Tiel, Gelderland, Netherlands, 4002 WP
	Contact: Willy Rijnten, MD w.rijnten@zrt.nl
	Sub-Investigator: Mieke Walg

Netherlands, Limburg
	Vie Curi	Recruiting
	Venlo / Venray, Limburg, Netherlands, 5900 BX
	Contact: Michette de Rooij, MD, PhD mderooij@viecuri.nl
	Sub-Investigator: Carla Rippens

Netherlands, Noord Brabant
	Jeroen Bosch ziekenhuis	Recruiting
	Den Bosch, Noord Brabant, Netherlands, 5323 GV
	Contact: Henk Rijken, BA h.rijken@jbz.nl
	Sub-Investigator: Mery Jansen
	St Anna ziekenhuis	Recruiting
	Geldrop, Noord Brabant, Netherlands, 5664EH
	Contact: Roland Mommers, MD, PhD r.mommers@st-anna.nl
	Sub-Investigator: Marleen van Diessen
	Elkerliek ziekenhuis	Recruiting
	Deurne, Noord Brabant, Netherlands, 5751 CB
	Contact: Fransje Castelijns, MD fcastelijns@elkerliek.nl
	Sub-Investigator: Jose van den Westen
	Bernhoven ziekenhuis	Recruiting
	Veghel, Noord Brabant, Netherlands, 5461 AA
	Contact: Kees Peter de Roos, MD. PhD k.deroos@bernhoven.nl
	Sub-Investigator: Sevgi Mulazim

Netherlands, Zuid Holland
	IJssellandziekenhuis	Recruiting
	Capelle aan de IJssel, Zuid Holland, Netherlands, 2906 ZC
	Contact: Karin Timm, RN Ktimm@ysl.nl
	St Franciscus gasthuis	Recruiting
	Rotterdam, Zuid Holland, Netherlands, 3045 PM
	Contact: Miriam Loots, MD m.loots@sfg.nl
	Sub-Investigator: Saskia Klein, RN

Netherlands, Zuide Holland
	ErasmusMC	Recruiting
	Rotterdam, Zuide Holland, Netherlands, 3015 GJ
	Contact: Kai Munte, MD, PhD k.munte@erasmusmc.nl
	Sub-Investigator: Karin van Gemeren, RN

Sponsors and Collaborators

Radboud University

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators


Study Director:	Theo van Achterberg, RN, PhD	Center of quality of care research, Radboud University Nijmegen Medical Center

More Information

Publications:

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.

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.

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.

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.

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

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.

Study ID Numbers:	13091966, ZonMw 945-04-058
First Received:	September 12, 2005
Last Updated:	February 1, 2006
ClinicalTrials.gov Identifier:	NCT00184873
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

randomized controlled trial

health-counseling

multi-center study

Study placed in the following topic categories:

Varicose Ulcer

Varicose Veins

Skin Diseases

Ulcer

Vascular Diseases

Skin Ulcer

Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Radboud University ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00184873