Exercise therapy with risk factor management and life style coaching after vascular intervention for patients with peripheral arterial disease with critical limb ischemia or tissue loss.

Supervised exercise therapy is nationally and internationally the treatment of
choice for patients with peripheral arterial disease with symptoms of
intermittent claudication (Rutherford classification 2-4). This symptomatic
treatment is combined with cardiovascular risk factor management. The results
of supervised exercise therapy in this patient population are good. In
addition, an increase in quality of life is visible, along with a decrease in
medical costs. The nationwide availability of supervised exercise therapy for
patients with intermittent claudication has increased since 2003, with reaching
a national coverage of trained physiotherapists in 2013 by.
For patients with peripheral arterial disease with symptoms of critical
ischemia or limited tissue loss (Rutherford classification 5-6), treatment is
primarily aimed at preserving the leg and the function thereof. This combined
with the treatment of cardiovascular risk factors, including proper treatment
of hypertension, diabetes mellitus and hypercholesterolemia. Estimates of the
incidence of critical ischemia range from 0.3 to 1 per 1,000 inhabitants per
year, with a prevalence of 0.04 to 0.1%. This patient population is generally
much more vulnerable than patients with intermittent claudication and, given
the frequent comorbidity result in a high morbidity and mortality. The primary
treatment of critical ischemia is in 50% of patients a revascularization, in
25% a primary amputation and 25% pharmaceutical. After only one year 30% has
been through an amputation and 25% deceased to predominantly cardiovascular
causes.
The 5-year survival of patients with peripheral arterial disease Rutherford 5-6
is 40%. The main variables after an intervention on mortality is not the type
of intervention that has been done, or the level of the diseased arterial
segment but is determined by the presence of reduced mobility before surgery,
not regaining mobility after surgery, loss of autonomy with respect to housing
and the presence of dementia.
In the current national and international guidelines for the treatment of
patients with Rutherford 5-6, the primary focus is to maintain the affected
limb using a vascular intervention, drug treatment and cardiovascular risk
factor management. Studies in this patient population on improving mobility
with custom supervised exercise therapy, early diagnosis and treatment of
dementia and risk factor management with lifestyle coaching were not conducted.

This pilot study examines the effects of supplementing the standard treatment
interventions to improve mobility with modified supervised exercise therapy
together with improvements in cardiovascular risk management by using an
intensive risk factor management and lifestyle coaching program supervised by a
physiotherapist. The results of this pilot study will be used to develop a
multicenter study on the treatment of patients with peripheral arterial disease
Rutherford 5-6.

The treatment of patients in the intervention group consists of several facets:
identification of all cardiovascular risk factors and analysis of adequacy of
the chosen therapy. If necessary, refer to the vascular physician or family
doctor. Research on degree of confusion and dementia using questionnaires
administered by the researcher and this is the case a reference to the
geriatric medicine department. After the last clinic visit prior to the
scheduled revascularization procedure the patient visits the physiotherapist in
the neighbourhood. Participating physiotherapists are all part of
ClaudicatioNet. This first session is part of preoperative preparation and
lifestyle coaching: the current level of activity, medication use, eating and
exercise habits, smoking, pulmonary exercises, physical health and exercise
therapy. During the week of hospital discharge after vascular intervention, the
patient goes back to the physiotherapist for treatment, if necessary, the
physical therapist visits at home. During these sessions, in addition to
exercise therapy, attention to lifestyle coaching will be present. Lifestyle
coaching includes attention to: medication adherence, stop-smoking counselling,
food and weight counselling, and fitness training.

The treatment of patients in the intervention group consists of several facets:
identification of all cardiovascular risk factors and analysis of adequacy of
the chosen therapy. If necessary, refer to the vascular physician or family
doctor. Research on degree of confusion and dementia using questionnaires
administered by the researcher and if this is the case a reference to the
geriatric medicine department. After the last clinic visit prior to the
scheduled revascularization procedure physiotherapist visits the patient has
been in the neighbourhood.
Participating physiotherapists are all part of ClaudicatioNet. This first
session is part of preoperative preparation and lifestyle coaching the
following offer: the current level of activity, medication use, eating and
exercise habits, smoking, pulmonary exercises, Conditioning and exercise
therapy. During the week of hospital discharge after vascular intervention, the
patient goes back to the physiotherapist for treatment, if necessary, physical
therapist visits the home. During these sessions, in addition to exercise
therapy, attention to lifestyle coaching is given. Lifestyle coaching includes
attention to: medication adherence, stop-smoking, weight monitoring and fitness
training.
Patients in the control group received the current standard treatment. This
includes cardiovascular risk management if not previously initiated by a doctor
or specialist, oral exercise advice and regular duplex controls. These take
place at 1, 3, 6, 9 and 12 months after the intervention.

Control and intervention group 10 hours a year basis for completion of the
questionnaires. The physiotherapy group receives an average of 2 times per week
therapy for a period of one year.