Background Intermittent claudication is usually caused by atherosclerotic stenoses and/or occlusions in the arteries to the legs and affects 7% of the Swedish population aged 60 years or more. Evidence-based treatment is best medical treatment (BMT) and exercise therapy. Best medical treatment includes treatment of risk factors for arteriosclerosis. Regarding exercise therapy, in-hospital supervised exercise therapy (SET) on a graded treadmill is known to improve walking performance as measured on the graded treadmill after three and six months. There is only scarce data on long-term results and very limited data regarding improvement of health related quality of life (HRQoL) by SET. In most countries, walk advice (WA) is routine clinical practice and resources for SET are often lacking. Invasive treatment (surgical or endovascular) is rarely required for patients with intermittent claudication.
New techniques (GPS and accelerometers) enable measurement of physical activity and training in home environment. The use of such techniques could facilitate home-based (HET) instead of hospital-based supervised exercise (SET) therapy by providing the caregiver data that could be used for feedback to the patient in order to obtain optimal patient benefit by the exercise therapy. This raises hope that results of and the long-term compliance to exercise therapy may improve.
Aim: in patients with intermittent claudication (IC) who do not require invasive treatment evaluate walking performance, HRQoL, fulfillment of patient-defined goals with treatment, walking impairment, long-term compliance to exercise therapy, physical activity and cost-effectiveness for different exercise therapy modalities in order to define the most effective and cost effective treatment.
One hundred and sixty-five IC patients requesting treatment for their IC symptoms in the vascular surgical departments of Sahlgrenska University Hospital and Södra Älvsborg Hospital, Sweden and in whom invasive treatment is not considered necessary are randomized (computerized adaptive stratified randomization) to
1. WA with Nordic Poles (NP) + best medical treatment (BMT), or
2. WA with NP + BMT + SET, or
3. WA with NP + BMT + HET
All randomized patients are recommended outdoor walking with NP at least 30 minutes at least three times per week. The SET group in addition receives in-hospital muscle exercise therapy in a group supervised by a physiotherapist three times weekly during six months. The HET group patients perform the same muscle exercise therapy at home with feedback every 14th day from a physiotherapist during six months. After the six months of supervised exercise therapy, the SET and HET patients are recommended to continue the same muscle exercise therapy at home, but without feedback, between seven and 12 months. The patients are followed by a blinded observer (physiotherapist unaware of the patient´s randomized group) at three, six and 12 months.
Primary outcome: change from baseline to 12 months in walking distance during six-minutes-walk-test (6MWT) and co-primary outcome: change from baseline to 12 months in health-related quality of life (SF36).
Secondary outcomes: walking impairment as measured by the Walking Impairment Questionnaire (WIQ), fulfillment of patient-defined goals (Patient-Specific-Functional Scale), physical activity (accelerometer), compliance to exercise therapy (patient diary), disease-specific HRQoL (VascuQol) and cost-effectiveness. Also change over time (baseline to three, baseline to six and six to 12 months) is studied.
It is important to determine whether the supervised exercise therapy modalities (SET and HET) have equivalent results and are better than WA with NP and BMT alone. The trial is designed to answer the question whether HET is not significantly less clinically effective as SET and whether SET is more clinically effective than WA with NP and BMT. The study started in September 2014, inclusion is expected to stop in September 2016 and end of follow-up is September 2017.
