The US Centers for Medicare and Medicaid Services (CMS) has determined that there is now sufficient evidence to cover supervised exercise therapy for the treatment of intermittent claudication. This decision will likely provide a boost to supervised exercise therapy programmes in the USA, with US physicians now enjoying greater flexibility when considering approaches for intermittent claudication. However, supervised exercise therapy is not without its obstacles. Vascular News spoke to an international selection of experts, who noted that poor patient adherence, lack of funding and physician disinterest still represent barriers to widespread adoption of such programmes.
The biggest challenge “is that patients find these programmes painful, slow, and time-consuming,” says Michael Jaff (Boston, USA), while Alberto Muñoz (Bogota, Colombia) cites “the lack of available programmes to which to refer patients, patient comorbidities, grades of disability and noncompliance to exercise recommendations.”
Jihad Mustapha concurs, noting that many patients hope for “some sort of magical intervention” that will take away the pain they are experiencing. He explains, “When I sit down with patients to explain that I need them to start a walking/exercise programme, they immediately respond by saying, ‘The reason I am here is that I cannot walk, and now you are asking me to walk?’ We as physicians have to take a stand. We ask patients to walk three or four times per week and then we will see them again in three months and re-evaluate. We are all familiar with what kind of response you get when they come back. ‘Well doc, I tried, but I could not walk more than two minutes,’ or, ‘Well doc, my calf hurt so I stopped’ We all know that these patients already have a mindset that they have a disease that is preventing them from walking. We have to retrain them mentally and physically and show them that they can walk more than two minutes and gain improvement. This is where a supervised walking programme becomes extremely valuable.”
Cliff Shearman (Southampton, UK) also notes, “Many patients are less enthusiastic about a therapy that demands a change to their lifestyle, requires commitment, and for which the benefits take time to emerge. The idea of a ‘quick fix’ from an intervention is often perceived as the best and easiest option. Many patients who initially agree to enrol in a supervised exercise therapy find it proves inconvenient and difficult to access, and will then understandably disengage.”
Aside from patient adherence, the resources needed to successfully run such programmes must be considered. Maarit Venermo (Helsinki, Finland), explains, “In a public health care system like in Finland, primary health care should provide risk factor management and initiation of statins and antithrombotic agents to patients. At the same time, primary health care should take care of supervised exercise therapy, but it has been too big a challenge as the number of patients is not enormous, compliance of the patients is poor and other duties are prioritised before this.”
In the USA, “Not many institutions have implemented a dedicated programme, space, and personnel who are informed and educated about the psychological and pathological components of claudication that they can safely educate these patients while giving them physical rehabilitation,” says Mustapha.
In the UK, Shearman says that there is a lack of enthusiasm for setting up and running supervised exercise therapy programmes. “This is not surprising as most vascular specialists are trained to carry out interventions, and this is what they are usually most interested in. Patients with intermittent claudication often have earlier, focal disease making them an attractive option for interventions such as angioplasty. Even where interest in running programmes exists, difficulties with funding occur. Although cost-effective and relatively inexpensive, the question of who should fund a programme has no clear answer; should it be a community/primary care facility or a hospital-based/secondary care service? Often this results in no-one funding the programme.”
A lack of suitable exercise programmes presents a barrier to Colombian patient care, Muñoz says. “In Colombia there is a lack of programmes offering supervised exercise to treat patients with intermittent claudication and peripheral artery disease, so most of our patients are prescribed a home-based exercise plan. In our group we instruct the patient to walk—depending on their functional status—20–30 minutes to start, for three to five days a week. The patient is advised to stop walking when claudication pain is considered moderate, so they should not stop at the onset of claudication, and to rest until pain or symptom is over, after which the patient should continue walking until moderate claudication recurs. This cycle of exercise and rest should be at least 20–40 minutes at the beginning and increase day to day to 50–60 minutes as the patient tolerates better exercise sessions. We follow-up with them at one and two months, and then every two months after that. At six months we evaluate his functional status, maximum walking time, walking ability, pain-free walking distance and maximum walking distance. For patients who do not respond, have suitable anatomy and are fit, we consider endovascular or open revascularisation.”
Despite these existing challenges, the CMS’ decision is an exciting landmark for peripheral artery disease. “I believe supervised exercise programmes in and outside the USA bring many positive features for the claudicant patient,” Mustapha suggests. “Patients feel that there is an element of seriousness to the walking component of the therapy when they are in an institutional setting with dedicated personnel supervising their walking activities. When they get to a point where they feel they cannot take any further steps—the first element of emotional fatigue rather than true physical inability—it is the first turning point in training our claudicants that they can do more than they think. The experienced supervisor pushes the claudicant to go further, showing the patient that they can go beyond the cut-off line they determine for themselves; it is a very valuable emotional teaching point. This also changes patient perception of physical inability to walk due to claudication. Patients also start to realise that they are accountable for their own well-being. Time after time, most of these patients find themselves surpassing their mental and physical perceived physical inability. This is when they start to see positive results which reinforce the value of the supervised walking programme.”
With every patient with claudication, Venermo explains that she carefully discusses the prognosis of claudication, whether the patient really exercises and engages with risk factor management including cessation of smoking, and also the invasive treatment methods and the risks related to invasive treatment. “Of course, in every patient the risks and benefits of supervised exercise therapy/invasive treatment also depends on the anatomical location of the arterial lesions. Many patients are relieved when they hear that claudication pain is not dangerous and that as long as the symptom is claudication, there is no risk of amputation. Patient motivation is crucial, as is proper information about the risks of invasive procedures. Usually patients are happy when I tell them that they should try exercise for three months and we can always re-evaluate the need of invasive therapy. In the end, surprisingly, many patients are happy without percutaneous transluminal angioplasty or bypass after they undertake regular walking exercise.”
The global context
The extent of supervised exercise therapy programme provision and the structure of such programmes vary worldwide.
“In the UK supervised exercise programme availability is very patchy,” Shearman says. Despite the 2012 National Institute for Health and Clinical Excellence (NICE) recommendation that supervised exercise therapy should be offered to patients with intermittent claudication, it seems that considerably less than half of patients are offered enrolment in such a programme. There is also great variation in the advice about exercise that patients with intermittent claudication are given. Exercise programmes vary from attending a nurse- or physio-led clinic through to simple advice about exercise. Even the type of exercise varies from walking through to exercise such as step ups.”
In Finland, the public health care system does not systematically provide supervised exercise therapy for patients who have claudication due to peripheral artery disease. Venermo explained to Vascular News, “In Helsinki University Hospital, patients are given oral instructions by the vascular surgeon to walk three times a week, one hour each time and to reach the maximum walking distance as many times as possible during this one hour training. Additionally, we recommend the use of sticks (Nordic walking) due to the fact that these increase the maximum walking distance.”
“In Colombia, patients with suspected intermittent claudication or peripheral artery disease are assessed with non-invasive studies, predominantly ankle brachial index, pulse volume recordings and colour flow duplex scanning,” Muñoz explains. “If a non-invasive exam is normal, an exercise study is performed. Additional studies such as computed tomography and magnetic resonance angiograms are only recommended for patients considered for intervention. Intermittent claudication and peripheral artery disease are mainly treated conservatively with an emphasis on risk factor control, lifestyle modification, smoking cessation and medical therapies. Intervention is reserved for patients with severe symptoms and who do not have a good medical response. Exercise is one of the most important aspects of treatment, looking to improve claudication, cardiovascular and functional status. It has been established that peripheral artery disease accelerates functional decline and physical disability. Exercise therapy has the potential to benefit patients with peripheral artery disease by preserving or improving functional capacity and reducing cardiovascular events.
In Muñoz’s practice in Bogota, “we perform ankle brachial index and duplex scanning for diagnosis, start full medical treatment with lifestyle modification, medications and home exercise for all patients. During follow-up at six months, if there is no response we will go for an imaging study like a computed tomography angiogram, magnetic resonance angiogram or angiography to consider endovascular treatment or open surgery.”
With supervised exercise therapy gaining recognition, the future looks bright. “Over the next 12 months I can see a promising shift in many institutions to initiate such programmes,” Mustapha says. “I, for one, believe in this and hope to see it implemented and utilised as it does make a difference for our claudicant patients.”
That said, there are questions that remain unanswered. “More evidence needs to be gained as to the optimum method and duration of exercise programmes so they can be standardised,” believes Shearman. “With the increasing availability of individual physical activity monitoring devices the opportunities for better ways of delivering programmes seem enormous.”