H.J.P Fokkenrood

Innovative strategies for
intermittent claudication

towards a stepped care approach and new outcome measures

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METHODS


Participants.

 We included studies that investigated the role of SET in patients diagnosed with IC (Fontaine II/ Rutherford 1-3).


Types of studies

 Eligible studies examined SET alone or in a comparison model with other treatments such as endovascular treatment, vasoactive medication, or non- SET. Randomized and nonrandomized studies were included. Although treadmill walking is considered an important component of a SET program, uncertainty remains regarding the most effective content of such a program.25 All types of SET programs were therefore included (eg, pole-striding and strength training). The search was limited to studies in humans and articles written in Dutch, German, or English. No limitation to date of publication was considered.


Search strategy.

 We performed a search in MEDLINE (1966 to June 2013) using the following Medical Subject Heading terms: "peripheral arterial diseases," "peripheral vascular diseases," "intermittent claudication," "peripheral arter* occlus*," "claudica*," "isch* limb*," "exercise," "exercise therapy," "exercise movement techniques," "walk*," "runni*," "exerc*," "train*," and "treadmill." Additional articles were found by

matching a previous search of Cochrane Central Register of Controlled Trials (1966 to September 2012) and EMBASE (1974 to June 2013) and removing duplicates. We also searched bibliographies of included articles. After screening titles and abstracts, two reviewers (L.G., H.F.) independently selected articles, based on a full-text evaluation. Disagreement between reviewers was discussed and resolved by consensus.


Data extraction and management.

 Two authors (L.G., H.F.) used a standardized data extraction form to extract the following data: details of the study population, country, research setting, number of participants, number of dropouts/lost to follow-up, reasons for dropout, age, gender, inclusion and exclusion criteria, description of the supervised exercise protocol, frequency, duration, content, all types of reported complications related to SET, and the use of cardiopulmonary exercise testing (CPET). To exclude the potential influence of medication, only results obtained from participants in the placebo control group of randomized controlled trials were included. If studies did not explicitly report possible occurrence of adverse events, we used information on the number of dropouts and reasons for dropout. Studies that contained dropouts due to medical causes were excluded. An E-mail was sent to authors who reported unclear data regarding SET-related complications or reasons for dropout to obtain details on the occurrence of untoward events. Studies of authors who did not respond to this e-mail were also excluded.


Statistical analysis and data synthesis.

 Data were analyzed using SPSS 18.0 software (SPSS Inc, Chicago, Ill). The total number of patient-hours was calculated as the number of patients multiplied by the number of training sessions corrected for the mean duration of each session. When information on the exact duration of training sessions was lacking, an approximation of 30 minutes was assumed. Adverse events were character- ized as cardiac or noncardiac. The role of cardiac screening was studied by performing a sub analysis. We calculated separated event rates based on the use of CPET before SET.