Validation of a Questionnaire Evaluating the Physical Activities in COPD Patients: the Maugeri Physical Activity Questionnaire - MaPAct
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 195
- Locations
- 1
- Primary Endpoint
- Questionnaire validity
Study Overview
Brief Summary
Patients affected from Chronic Obstructive Pulmonary Disease (COPD) benefit from pulmonary rehabilitation in terms of exercise capacity, symptoms and health-related quality of life whereas the effect on physical activity is still not clear. Some studies have investigated the effect of exercise training on daily physical activity. However, there is considerable variability in study findings, data are discordant and the effect of exercise training on physical activity is unclear. There are probably a number of reasons to account for this.
First of all, the choice of the method for evaluating physical activity. Although direct observation, double-labelled water and calorimetry are considered the gold standard for assessing physical activity, they are too time consuming and expensive to be used in large population studies .The Physical Activity (PA) of patients with COPD can be assessed using questionnaires. A variety of questionnaires exist that capture different aspects of physical activity such as amount, type, intensity, symptom experience and limitations in the performance of ''activities of daily life''. Up to now, it still does not exist an instrument that evaluates the physical activity of COPD patients in Italian language that takes in account Italian people' lifestyle. Since this is strongly influenced by the environment, cultural and social conditions in which we live, it is essential to have an instrument specifically tailored for the population under study.
Aim of this study is to validate the Maugeri Physical Activity questionnaire (MaPAct) in COPD patients pointing to assess self-perceived physical activity.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •COPD diagnosis in stable state, able to read and to write, that accept to sign informed consent
Exclusion Criteria
- •will be excluded all patients that were hospitalized in the 30 days before evaluation, patients with degenerative neuromuscular diseases, subjects with motor disabilities limiting deambulation, subjects with memory or comprehension problems, with dementia, parkinson disease, cognitive impairment, and subject that do not give their consent for the participation to the study
Arms & Interventions
experimental group
COPD patients will be asked to fill in the Maugeri Physical Activity Questionnaire (MaPAct) to assess self perceived physical activity.
Intervention: questionnaire (Behavioral)
Outcomes
Primary Outcomes
Questionnaire validity
Time Frame: six months
Numeric score
Secondary Outcomes
- Questionnaire reliability(six months)
Investigators
Elisabetta Zampogna
Principal Investigator
Fondazione Salvatore Maugeri