Evaluation of Physical Activity in Asthmatic Subjects
Condition: Asthma; Physical Activity
Study type: Interventional

Summary: 
      Asthma is a chronic disease, which leads to a number of adverse outcomes, including lower
      levels of physical activity (PA). Physical inactivity is an important risk factor, increasing
      PA has become a patient-centred goal for the treatment of subjects with asthma. Data provided
      by activity monitors are commonly used to measure daily PA.

      A recent systematic review showed that adults with asthma had lower levels of total, moderate
      and vigorous physical activity than those without asthma. There are no data showing the
      possible effects of a Pulmonary Rehabilitation (PR) program on PA (number of daily steps) in
      normal-weight subjects with asthma. The main objective of this pilot study is to obtain
      estimates of the mean value of number of daily steps, time spent on activity in hours and of
      other variables in normal-weight subjects with asthma measured before and after the PR
      program. No estimates about these parameters in the same population are currently available
      from literature search.
    

Detailed description: 
      Asthma is a chronic disease, which leads to a number of adverse outcomes, including possible
      lower levels of physical activity (PA). Physical inactivity is an important risk factor, it
      and was shown that training improves cardiopulmonary fitness, symptoms and quality of life.
      Increasing PA has become a patient-centred goal for the treatment of subjects with asthma.

      Data provided by activity monitors are commonly used to measure daily PA. For PA assessments
      using an accelerometer, recordings of at least 4 weekly days with a minimum of 8 hours of
      monitor use (during waking hours) are recommended. A recent systematic review showed that
      adults with asthma had lower levels of total, moderate and vigorous physical activity than
      those without asthma. Physical activity appears to be influenced by comorbidities such as
      obesity in addition to age and sex, decreased disease control, and increased severity. Ather
      authors involved obese subjects with asthma assigned to a 12-month lifestyle intervention
      dually targeted modest weight loss (achieve and maintain a weight loss of 7% of baseline body
      weight) and increased physical activity (achieve and maintain a minimum of 150 minutes per
      week of moderate intensity physical activity) compared with usual care (control group).
      Moderately and severely obese adults with uncontrolled asthma showed modest average weight
      reduction and PA improvements. Finally was showed that a comprehensive pulmonary
      rehabilitation (PR) program including a weight loss program and exercise training improves PA
      in moderately-severely obese adults with asthma.

      There are no data showing the possible effects of a PR program on PA (number of daily steps)
      in normal-weight subjects with asthma.

      The main objective of this pilot study is to obtain estimates of the mean value (and standard
      deviation) of number of daily steps, time spent on activity in hours and of other variables
      in normal-weight subjects with asthma measured before and after the PR program. No estimates
      about these parameters in the same population are currently available from literature search.
      This information will be used for formal sample size calculations when planning a future
      larger study investigating the number of daily steps and time in activity of normal-weight
      subjects with asthma before and after PR.
    

Intervention name(s): Pulmonary Rehabilitation
Intervention type(s): Other
Intervention description(s): The enrolled subjects will receivePR program. The 3 weeks inpatient PR will include education, exercise training, nutritional and psychological counselling.
Education: individualized session of 20 minutes each and group session of 45 minutes each. Endurance training: at least twelve 30-minute daily sessions of supervised incremental exercise training according to Maltais, continuous cycling at 50-70% of the maximal load calculated on the basis of the baseline 6MWT according to Hill. Strength training: twelve 30-minute daily sessions of peripheral limb muscle strength training: 2 set of 8 repetitions during the first week, increased at 12 from the second. The initial load will be set at 30/50% of maximal voluntary isometric strength (MVS). Psychological intervention: individual tailored intervention will be offered when the Hospital Anxiety and Depression Scale (HADS) score is >10 or judged necessary by clinicians, after verifying the subject's motivation.
Intervention model: Single Group Assignment
Intervention model description: Prospective
Masking: None (Open Label)
Primary purpose: Diagnostic