Validation of a Questionnaire Evaluating the Physical Activities in COPD Patients: the Maugeri Physical Activity Questionnaire - MaPAct

Methods The study will be approved by the Internal Review Board and Ethics Committee of the Salvatore Maugeri Foundation, Institute of Care and Scientific Research Rehabilitation of Tradate and Lumezzane, Italy and Malcantonese Hospital, Castelrotto, Switzerland. The procedures will be performed between September 2016 to September 2018.

Study design A team of experts, (1 pulmonologist, 1 bioengineer, 4 physiotherapists, 1 psychologist and 1 psychometrist) elaborated the instruments and defined the instructions to administer the MaPAct to self-evaluate the physical activity during daily life. This phase distinguishes three steps.

Subjects A total of 195 in-hospital patients (15 in a first step, 50 in a second step and 130 in the third) with diagnosis of COPD, will be enrolled. Will be excluded from the study all the patients that were hospitalized in the 30 days before admission, patients with degenerative neuromuscular disease, subjects with motor disabilities limiting ambulation, subjects with memory or comprehension problems, with dementia, Parkinson disease, and subjects that do not give their consent to the participation to the study. All subjects receive a consent informed.

Step 1 A focus group of 15 patients will be arranged and patients will be asked to fill in the preliminary version of the questionnaire and to offer their impression. In this pilot step patients will be also asked to discuss on the relevance for the study population and comprehensiveness of the items describing them generically as 'clear' or 'unclear', "appropriate" or "not appropriate" to themselves (16-17), the aim being to achieve consensus for each item. Where items were described as "not appropriate" or "unclear", participants should explain their reasons. Some items should be removed at this stage, or reworded if necessary. The objective was to include all items judged to be relevant to COPD patients. These items will form the Item Set.

Step 2 The patient-perceived comprehensibility will be tested on a sample of 50 patients. Patients will be asked to rank their perceived comprehensibility of the questionnaire on a 4-point Likert scale, between 0 and 3 (0 =Easy, 1 =Quite easy, 2 = Quite difficult, and 3 = Difficult). Some items should be removed at this stage, or reworded if necessary.