Interactive Video Game Responses in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Cystic fibrosis (CF) is a disease that affects multiple systems, however, the accumulation of
      secretion in the airways contributes to the fact that pulmonary complications are the main
      responsible for the high rates of morbidity and mortality. Physical exercise can be an
      important component in the treatment of these patients, and modalities such as Nintendo Wii
      and Xbox One stand out as feasible and innovative methods that can contribute to increase
      adherence to rehabilitation. Thus, the objective of this study is to compare the
      cardiorespiratory responses during a maximal exercise test with the use of Nintendo Wii and
      Xbox One in patients with CF and healthy individuals. Patients with a clinical diagnosis of
      CF, aged from 6 to 30 years old and in stable clinical conditions will be included. For
      healthy individuals, those who are considered healthy from the application of a health
      questionnaire and also aged from 6 to 30 years old will be included. Patients in both groups
      with cardiopathies, musculoskeletal diseases, neurological diseases or signs of pulmonary
      exacerbation will be excluded. Participants will complete a questionnaire to assess their
      level of physical activity. Afterwards, cardiopulmonary exercise test (CPET) will be
      performed (visit 1), followed by the use of video games (visit 2). The video game will be
      practiced using a Nintendo Wii and a Xbox One (10 minutes each). A rest of 10 minutes will be
      provided between the use of each video game. During the interactive games, patients will use
      an accelerometer to assess the level of physical activity. In parallel to this, healthy
      subjects will be invited to perform the same tests in two visits. To evaluate the perception
      of fatigue, the OMNI scale will be used. In addition, individuals will be asked to evaluate
      their level of satisfaction after each game.
    

Detailed description: 
      Cardiopulmonary exercise test: The test will be performed according to the recommendations of
      the American Thoracic Society and American College of Chest Physician.The variables to be
      measured includes maximal oxygen uptake (VO2max), maximal ventilation (Vemax), respiratory
      quotient (RQ), peripheral oxygen saturation (SpO2), subjective levels of dyspnea and fatigue
      in the legs (modified BORG scale), pulse oxygen (VO2/HR) and maximal heart rate (HRmax).
      During the test, the individuals will be asked to walk for 2 minutes to adapt to the
      treadmill, with a speed of 3 km/h and without inclination. After that, there will be
      increments in the speed of 0.5 Km/h, every minute, with a fixed slope of 3%, until the end of
      the test. All individuals will be encouraged to keep the pace until signs of exhaustion or
      limiting symptoms appear (dyspnea, leg pain and/or dizziness). To be considered a maximal
      test, at least three of the following criteria should be observed: exhaustion or inability to
      maintain the required speed, RQ>1.10, maximal achieved HR>85% of the estimated HR (formula:
      220- Age) and the presence of a plateau in the VO2max.

      Interactive Video Games: Participants will use Nintendo Wii for 10 minutes and then use Xbox
      One for 10 minutes, taking a 10-minute rest between one console and another. During the two
      video games, patients will use a Neoprene mask to collect gases, including maximal oxygen
      (VO2), carbon dioxide (CO2), maximal ventilation (VEmax), respiratory quotient (RQ) and the
      metabolic equivalents for oxygen (VE/VO2) and for carbon dioxide (VE/VCO2). In addition,
      peripheral oxygen saturation (SpO2), subjective levels of dyspnea and fatigue in the legs
      (modified BORG scale), pulse oxygen (VO2/HR) and maximal heart rate (HRmax) before and after
      Intervention will be collected.

      Accelerometer: All participants will use an accelerometer while playing in the interactive
      video games. This equipment will be used on the left side of the waist. The results of the
      physical activity variables will be expressed as mean counts/min, as a mean indicator of the
      intensity of physical activity. In addition, the time spent in activities according to their
      intensity will be classified as sedentary (<100 counts), mild (≥100 counts) and moderate to
      vigorous (>2296 counts).

      Scales: In the OMNI scale, individuals point out on a scale of 0 to 10 the fatigue level,
      where 0 is very easy and 10 is very difficult.Also, the level of satisfaction will be
      evaluated using a 5-point Likert scale where 1 represents no satisfaction and 5 much
      satisfaction.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with cystic fibrosis, recruited at the CF center of Hospital São Lucas (PUCRS),
        and healthy individuals recruited from the loccal community.
      
Keywords: cystic fibrosis; video games; exercise; maximal oxygen consumption