Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication (SUNFIT)
Intermittent Claudication
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring intermittent claudication, exercise therapy, physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Intermittent claudication in one or both legs with a typical history and ankle-brachial-index (ABI) 0.90 or less and/or 30% or more post-exercise reduction of ABI.
- Symptom duration > 6 months.
- Intermittent claudication is the walk limiting condition.
Exclusion Criteria:
- Invasive treatment for intermittent claudication performed within three months
- Invasive treatment for intermittent claudication considered necessary within 12 months
- Inability to understand Swedish, answer questionnaires or perform walk test
Sites / Locations
- Södra Älvsborgs Hospital
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Walk advice
Hospital-based supervised exercise
Home-based supervised exercise
All WA patients receive best medical treatment (BMT) including control of risk factors for arteriosclerosis, simvastatin 40 mg daily, aspirin 75 mg daily and are recommended outdoor walking with Nordic Poles at least 30 minutes at least three times per week. The WA patients are unsupervised during the study period and are followed by a blinded observer at baseline, three, six and 12 months.
All SET patients receive the same basic treatment as WA patients: best medical treatment (BMT) including control of risk factors for arteriosclerosis, simvastatin 40 mg daily, aspirin 75 mg daily and recommendation of outdoor walking with Nordic Poles at least 30 minutes at least three times per week. The SET group in addition receives three times weekly during six months in-hospital muscle exercise therapy in a group supervised by a physiotherapist. After the six months of supervised exercise therapy, the SET patients are recommended to continue the same muscle exercise therapy at home, but without feedback, between seven and 12 months.
All HET patients receive the same basic treatment as WA patients: best medical treatment (BMT) including control of risk factors for arteriosclerosis, simvastatin 40 mg daily, aspirin 75 mg daily and recommendation of outdoor walking with Nordic Poles at least 30 minutes at least three times per week. The HET group patients in addition perform the same muscle exercise therapy three times weekly during six months as the SET patients, but in their homes, and are supervised and given feedback by phone calls every 14th day by a physiotherapist. After six months of supervised exercise therapy, the HET patients are recommended to continue the same muscle exercise therapy, but without feedback, between seven and 12 months.