H.J.P Fokkenrood

Innovative strategies for
intermittent claudication

towards a stepped care approach and new outcome measures



 Both the 2007 TransAtlantic Inter-Society Consensus (TASC II) and the 2012 NICE guideline are based on large meta-analyses. Both clearly advise SET as the first line treat- ment in the symptomatic treatment of patients with IC.(3,7)

 In chapter two, an update of such an underlying systematic meta-analysis is provided. It focuses on the effectiveness of SET compared to non-supervised exercise as earlier studied by Bendermacher et al. Although it is generally accepted that SET should be part of the initial treatment for each patient with IC, this therapeutic tool is seriously underused in clinical practice.

 Since these guidelines recommend SET as primary treatment for IC, a calculation of treatment costs in patients with IC was made in chapter three to estimate potential nationwide annual savings if a stepped care model (SCM; primary SET treatment fol- lowed by revascularization in case of SET failure) was followed. Data for this study were retrospectively obtained from a database of one of the largest health care providers in the Netherlands (CZ).

 Some physicians or physical therapists providing SET fear the onset of cardiovascular events that may possibly occur during exercise. Moreover, (outdated) physical therapists guidelines advocate cardiac screening prior to SET although evidence to support such a strategy is lacking. In chapter four, a systematic meta-analysis analyzes the safety of SET as reflected by the onset of untoward (cardiovascular) events in patients suffering from IC.

 Monitoring of both quality and performance is necessary to study effectiveness of suggested treatment strategies. This is particularly true in case of a nationwide SCM im- plementation. Structurally obtaining outcome indicators in combination with patient reported outcome measurements (PROMS) could be helpful in facilitating SCM imple- mentation. eHealth and mHealth initiatives may play a major role in both abovementi- oned goals and are outlined in chapter five in combination with future developments in the organization of a nationwide community based SET network. Innovative technolo- gies may lead to new insights in the conservative treatment of IC. These novel tools can be used to monitor the quality of provided care.


 In the second part of this thesis, the introduction of a possible new clinical outcome parameter is studied. A prospective case-control effort (chapter six) studies whether a bicycle test is a reliable alternative diagnostic tool compared to a standard treadmill test in patients possibly having IC.

 A clear call was made for alternative tests to determine walking capacity over a pro- longed period of time. In chapter seven, the clinical applicability of various types of treadmill protocols is investigated. Moreover, despite the fact that IC patients have an increased risk for cardiovascular or cerebrovascular events, current PAD treatment is mainly focussed on the limitation in walking distance. However, an increased walking capacity does not automatically imply a change in a patients' exercise behaviour. From a therapeutic as well as research standpoint, it may be more relevant to determine exercise behaviour or physical activity (PA) as outcome measure for treatment modalities of IC. Therefore, the validity of an activity monitor determining physical activity and ambu- latory activities is investigated in a group of IC patients in chapter eight. Subsequently, outcome parameters obtained from this activity monitor are compared to healthy sub- jects in a prospective case control study in chapter nine. Subsequently the effect of a 3-month SET program on both physical activity and ambulatory activities is investigated in chapter ten.


 In chapter eleven, the main findings of this thesis are discussed. Methodological as- pects of the different studies, implications for clinical practice, and implications for future research are described. Finally in chapter twelve a valorization document is provided in Dutch.