Skip to main content
OpenTrials
Completed

NCT Number: NCT00184873

Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leg Ulcers Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Ulcers Varicose Veins Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Slingeland ziekenhuis, Doetinchem, Gelderland, Netherlands

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Counseling

Behavioral

Primary outcomes

  1. * Compliance with compression therapy

    Time frame: 18 months

  2. * Compliance with exercise prescriptions

    Time frame: 18 months

  3. * Leg ulcer recurrence

    Time frame: 18 months

Secondary outcomes

  1. * time to next ulcer / ulcer size and time to heal in case of recurrence /duration of ulcer free periods

    Time frame: 18 months

  2. * evaluation of the cost effectiveness of the program

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Feb 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.