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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance With Compression Therapy and Prescribed Exercise in Leg Ulcer Patients

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Leg Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

* Compliance with compression therapy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
* Compliance with exercise prescriptions [ Time Frame: 18 months ] [ Designated as safety issue: No ]
* Leg ulcer recurrence [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

* time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods [ Time Frame: 18 months ] [ Designated as safety issue: No ]
* evaluation of the cost effectiveness of the program [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	January 2005
Study Completion Date:	December 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lifestyle counseling Patients receiving lifestyle counseling	Behavioral: Health Counseling
No Intervention: Regular care Patients receiving regular care

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

Locations

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

Sponsors and Collaborators

Radboud University

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

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.

Responsible Party:	Prof. T. van Achterberg, IQ healthcare, Scientific Institute for Quality of Healthcare
ClinicalTrials.gov Identifier:	NCT00184873 History of Changes
Other Study ID Numbers:	13091966, ZonMw 945-04-058
Study First Received:	September 12, 2005
Last Updated:	February 8, 2010
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

Additional relevant MeSH terms:

Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases

Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 13, 2012