Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study Protocol

Condition(s) studied

Investigational drug(s) / intervention(s)

Accelerometer: For the following study, each patient will be asked to wear a portable device over a 7-day period. The accelerometer will be previously set up according to anthropometric data of the patient and scheduled to automatically start and stop accelerations registration. The patient will be asked to wear the sensor as frequently as possible, with the exception of sleep period and during aquatic activities. A diary will be delivered to the patient in order to notify any problem/issue observed during the evaluation week (for example forgetting to wear the sensor). The accelerometry assessment will be associated to a questionnaire. Each patient will have to fill in it during the evaluation week. The questionnaire is composed of various questions from three different questionnaires: Ricci \& Gagnon for subjective evaluation of PA level, CFQ-14+ for the evaluation of quality of life specifically in CF and EQ-5D for a more generic evaluation of quality of life.

Study summary

The aim of the study is to analyze the determinants (barriers and facilitators) of the daily physical activity level in a population of patients with cystic fibrosis. A population of patients will be included in order to realize an assessment of their daily physical activity level over an entire week. A specific questionnaire, designed from 3 different questionnaires, will be associated to the physical activity evaluation and will allow to asses psycho-social and environmental factors.

Eligibility

Primary outcome measure(s)

• Physical Activity Time — Week 1
  mean value of moderate to vigorous Physical Activity (MVPA) time (min/day), from an accelerometry evaluation over an entire week

Trial sites (6)

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