Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Hospital- or Home-based Supervised Exercise Therapy or Unsupervised Walk Advice for Patients With Intermittent Claudication
Brief Summary: The purpose of this randomized clinical trial is to determine and compare the clinical and cost effectiveness of three methods for exercise therapy as treatment for patients with intermittent claudication. The methods tested are a hospital-based (SET) and a home-based (HET) supervised exercise program and unsupervised walk advice (WA) and all patients are followed for 12 months. Unsupervised WA consists of advice of at least 30 minutes walking with Nordic Poles (NP) at least three times per week and this basic treatment, including best medical treatment, is used in all three treatment groups. In addition to this basic treatment, the SET group patients during the first six months participate in group-based exercise therapy in the hospital for 50 minutes three times weekly, supervised by a physiotherapist. The HET group patients perform the same exercise in their home 50 minutes three times weekly during six months receiving feedback from a physiotherapist by a phone call every 14th day. The SET and HET group patients are recommended to continue the 50 minutes three times weekly exercise therapy in their homes without supervision during the last six months. Primary outcome is change from baseline to 12 months in walking distance during six minutes in a hospital corridor (6MWT) and co-primary outcome is change from baseline to 12 months in health-related quality of life (HRQoL) using the SF36 questionnaire. Secondary outcomes include fulfillment of patient-specified goals with treatment (PSFS), change in health-related quality-of-life (HRQoL) with a disease-specific instrument (VascuQoL), walking impairment as measured by the Walking Impairment Questionnaire, physical activity (accelerometer) and compliance with physical exercise therapy (patient diary).