<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229213</url>
  </required_header>
  <id_info>
    <org_study_id>game</org_study_id>
    <nct_id>NCT03229213</nct_id>
  </id_info>
  <brief_title>Interactive Video Game Responses in Cystic Fibrosis</brief_title>
  <acronym>Igamecf</acronym>
  <official_title>Evaluation of Physiological Responses During the Use of Interactive Video Game and the Cardiopulmonary Exercise Test in Cystic Fibrosis and Healthy Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontificia Universidade Católica do Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pontificia Universidade Católica do Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cystic fibrosis (CF) is a disease that affects multiple systems, however, the accumulation of&#xD;
      secretion in the airways contributes to the fact that pulmonary complications are the main&#xD;
      responsible for the high rates of morbidity and mortality. Physical exercise can be an&#xD;
      important component in the treatment of these patients, and modalities such as Nintendo Wii&#xD;
      and Xbox One stand out as feasible and innovative methods that can contribute to increase&#xD;
      adherence to rehabilitation. Thus, the objective of this study is to compare the&#xD;
      cardiorespiratory responses during a maximal exercise test with the use of Nintendo Wii and&#xD;
      Xbox One in patients with CF and healthy individuals. Patients with a clinical diagnosis of&#xD;
      CF, aged from 6 to 30 years old and in stable clinical conditions will be included. For&#xD;
      healthy individuals, those who are considered healthy from the application of a health&#xD;
      questionnaire and also aged from 6 to 30 years old will be included. Patients in both groups&#xD;
      with cardiopathies, musculoskeletal diseases, neurological diseases or signs of pulmonary&#xD;
      exacerbation will be excluded. Participants will complete a questionnaire to assess their&#xD;
      level of physical activity. Afterwards, cardiopulmonary exercise test (CPET) will be&#xD;
      performed (visit 1), followed by the use of video games (visit 2). The video game will be&#xD;
      practiced using a Nintendo Wii and a Xbox One (10 minutes each). A rest of 10 minutes will be&#xD;
      provided between the use of each video game. During the interactive games, patients will use&#xD;
      an accelerometer to assess the level of physical activity. In parallel to this, healthy&#xD;
      subjects will be invited to perform the same tests in two visits. To evaluate the perception&#xD;
      of fatigue, the OMNI scale will be used. In addition, individuals will be asked to evaluate&#xD;
      their level of satisfaction after each game.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiopulmonary exercise test: The test will be performed according to the recommendations of&#xD;
      the American Thoracic Society and American College of Chest Physician.The variables to be&#xD;
      measured includes maximal oxygen uptake (VO2max), maximal ventilation (Vemax), respiratory&#xD;
      quotient (RQ), peripheral oxygen saturation (SpO2), subjective levels of dyspnea and fatigue&#xD;
      in the legs (modified BORG scale), pulse oxygen (VO2/HR) and maximal heart rate (HRmax).&#xD;
      During the test, the individuals will be asked to walk for 2 minutes to adapt to the&#xD;
      treadmill, with a speed of 3 km/h and without inclination. After that, there will be&#xD;
      increments in the speed of 0.5 Km/h, every minute, with a fixed slope of 3%, until the end of&#xD;
      the test. All individuals will be encouraged to keep the pace until signs of exhaustion or&#xD;
      limiting symptoms appear (dyspnea, leg pain and/or dizziness). To be considered a maximal&#xD;
      test, at least three of the following criteria should be observed: exhaustion or inability to&#xD;
      maintain the required speed, RQ&gt;1.10, maximal achieved HR&gt;85% of the estimated HR (formula:&#xD;
      220- Age) and the presence of a plateau in the VO2max.&#xD;
&#xD;
      Interactive Video Games: Participants will use Nintendo Wii for 10 minutes and then use Xbox&#xD;
      One for 10 minutes, taking a 10-minute rest between one console and another. During the two&#xD;
      video games, patients will use a Neoprene mask to collect gases, including maximal oxygen&#xD;
      (VO2), carbon dioxide (CO2), maximal ventilation (VEmax), respiratory quotient (RQ) and the&#xD;
      metabolic equivalents for oxygen (VE/VO2) and for carbon dioxide (VE/VCO2). In addition,&#xD;
      peripheral oxygen saturation (SpO2), subjective levels of dyspnea and fatigue in the legs&#xD;
      (modified BORG scale), pulse oxygen (VO2/HR) and maximal heart rate (HRmax) before and after&#xD;
      Intervention will be collected.&#xD;
&#xD;
      Accelerometer: All participants will use an accelerometer while playing in the interactive&#xD;
      video games. This equipment will be used on the left side of the waist. The results of the&#xD;
      physical activity variables will be expressed as mean counts/min, as a mean indicator of the&#xD;
      intensity of physical activity. In addition, the time spent in activities according to their&#xD;
      intensity will be classified as sedentary (&lt;100 counts), mild (≥100 counts) and moderate to&#xD;
      vigorous (&gt;2296 counts).&#xD;
&#xD;
      Scales: In the OMNI scale, individuals point out on a scale of 0 to 10 the fatigue level,&#xD;
      where 0 is very easy and 10 is very difficult.Also, the level of satisfaction will be&#xD;
      evaluated using a 5-point Likert scale where 1 represents no satisfaction and 5 much&#xD;
      satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal oxygen consumption</measure>
    <time_frame>Immediately after test or game</time_frame>
    <description>Maximal oxygen consumption will be assessed during a maximal cardiopulmonary exercise test and during de use of interactive video games.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal heart rate</measure>
    <time_frame>Immediately after test or game</time_frame>
    <description>Maximal heart rate will be measured using a heart monitor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction</measure>
    <time_frame>Immediately after games</time_frame>
    <description>Satisfaction will be evaluated using a 5 point likert scale where 1 represents no satisfaction and 5 much satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>Immediately after games</time_frame>
    <description>Physical activity levels will be evaluated using the accelerometer on the left side of the waist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective evaluation of dyspnea</measure>
    <time_frame>Immediately after test or game</time_frame>
    <description>Dyspnea will be evaluated using the modified BORG scale where 0 is no dyspnea and 10 is maximal dyspnea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of fatigue</measure>
    <time_frame>Immediately after games</time_frame>
    <description>Perception of fatigue will be evaluated using the OMNI scale where 0 is very easy and 10 is very difficult.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The peripheral oxygen saturation (SpO2)</measure>
    <time_frame>Immediately after test or game</time_frame>
    <description>The peripheral oxygen saturation will be evaluated using a pulse oximetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal ventilation (VEmax)</measure>
    <time_frame>Immediately after test or game</time_frame>
    <description>Maximal ventilation (VEmax) will be evaluated using a computerized system coupled to a gas analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory quotient (RQ)</measure>
    <time_frame>Immediately after test or game</time_frame>
    <description>The respiratory quotient (RQ) will be evaluated using a computerized system coupled to a gas analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic equivalents for oxygen (VE/VO2)</measure>
    <time_frame>Immediately after test or game</time_frame>
    <description>Metabolic equivalents for oxygen will be evaluated using a computerized system coupled to a gas analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic equivalents for carbon dioxide (VE/VCO2)</measure>
    <time_frame>Immediately after test or game</time_frame>
    <description>Metabolic equivalents for carbon dioxide Metabolic equivalents for oxygen will be evaluated using a computerized system coupled to a gas analyzer.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Cystic Fibrosis</arm_group_label>
    <description>Cystic fibrosis patients will be invited to participate in the study. All participants will complete a questionnaire to assess the level of physical activity prior to evaluation. On the first visit they will perform the cardiopulmonary exercise test (CPET) to evaluate cardiorespiratory responses during exercise. On the second visit an evaluation of the cardiorespiratory responses during the use of interactive video games (Nintendo Wii or Xbox One) will be performed. During interactive games, participants will use an accelerometer to assess the level of physical activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Healthy subjects will be invited to participate in the study. All participants will complete a questionnaire to assess the level of physical activity prior to evaluation. On the first visit they will perform the cardiopulmonary exercise test (CPET) to evaluate cardiorespiratory responses during exercise. On the second visit an evaluation of the cardiorespiratory responses during the use of interactive video games (Nintendo Wii or Xbox One) will be performed. During interactive games, participants will use an accelerometer to assess the level of physical activity.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with cystic fibrosis, recruited at the CF center of Hospital São Lucas (PUCRS),&#xD;
        and healthy individuals recruited from the loccal community.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cystic fibrosis - clinical diagnosis of cystic fibrosis confirmed by sweat test or genetic&#xD;
        test, aged from 6 to 30 years old and presenting stable clinical conditions.&#xD;
&#xD;
        Healthy individuals - to be considered healthy from the application of the health&#xD;
        questionnaire and aged from 6 to 30 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients in both groups who present with cardiopathies, musculoskeletal diseases,&#xD;
        neurological diseases or signs of pulmonary exacerbation will be excluded from the study.&#xD;
        In addition, those subjects who have difficulty in understanding or are unable to perform&#xD;
        the cardiopulmonary exercise test will also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcio Donadio, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pontificia Universidade Católica do Rio Grande do Sul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pontifífia Universidade Católica do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90619-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Bradley JM, Moran FM, Elborn JS. Evidence for physical therapies (airway clearance and physical training) in cystic fibrosis: an overview of five Cochrane systematic reviews. Respir Med. 2006 Feb;100(2):191-201. doi: 10.1016/j.rmed.2005.11.028.</citation>
    <PMID>16412951</PMID>
  </results_reference>
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    <citation>Main E. What is the best airway clearance technique in cystic fibrosis? Paediatr Respir Rev. 2013 May;14 Suppl 1:10-2. doi: 10.1016/j.prrv.2013.01.008. Epub 2013 Mar 26.</citation>
    <PMID>23541002</PMID>
  </results_reference>
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    <citation>Robinson M, Bye PT. Mucociliary clearance in cystic fibrosis. Pediatr Pulmonol. 2002 Apr;33(4):293-306. doi: 10.1002/ppul.10079.</citation>
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    <citation>Hamosh A, FitzSimmons SC, Macek M Jr, Knowles MR, Rosenstein BJ, Cutting GR. Comparison of the clinical manifestations of cystic fibrosis in black and white patients. J Pediatr. 1998 Feb;132(2):255-9. doi: 10.1016/s0022-3476(98)70441-x.</citation>
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    <citation>Grasemann H, Stehling F, Brunar H, Widmann R, Laliberte TW, Molina L, Doring G, Ratjen F. Inhalation of Moli1901 in patients with cystic fibrosis. Chest. 2007 May;131(5):1461-6. doi: 10.1378/chest.06-2085.</citation>
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    <citation>Boucher RC. Evidence for airway surface dehydration as the initiating event in CF airway disease. J Intern Med. 2007 Jan;261(1):5-16. doi: 10.1111/j.1365-2796.2006.01744.x.</citation>
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    <citation>Rosenstein BJ, Langbaum TS. Incidence of distal intestinal obstruction syndrome in cystic fibrosis. J Pediatr Gastroenterol Nutr. 1983 May;2(2):299-301.</citation>
    <PMID>6553601</PMID>
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    <citation>Salonini E, Gambazza S, Meneghelli I, Tridello G, Sanguanini M, Cazzarolli C, Zanini A, Assael BM. Active Video Game Playing in Children and Adolescents With Cystic Fibrosis: Exercise or Just Fun? Respir Care. 2015 Aug;60(8):1172-9. doi: 10.4187/respcare.03576. Epub 2015 Apr 21.</citation>
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    <citation>Lester MK, Flume PA. Airway-clearance therapy guidelines and implementation. Respir Care. 2009 Jun;54(6):733-50; discussion 751-3. doi: 10.4187/002013209790983205.</citation>
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    <citation>Marks JH. Airway clearance devices in cystic fibrosis. Paediatr Respir Rev. 2007 Mar;8(1):17-23. doi: 10.1016/j.prrv.2007.02.003. Epub 2007 Mar 21.</citation>
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    <citation>Smyth AR, Bell SC, Bojcin S, Bryon M, Duff A, Flume P, Kashirskaya N, Munck A, Ratjen F, Schwarzenberg SJ, Sermet-Gaudelus I, Southern KW, Taccetti G, Ullrich G, Wolfe S; European Cystic Fibrosis Society. European Cystic Fibrosis Society Standards of Care: Best Practice guidelines. J Cyst Fibros. 2014 May;13 Suppl 1:S23-42. doi: 10.1016/j.jcf.2014.03.010.</citation>
    <PMID>24856775</PMID>
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  <results_reference>
    <citation>Pinet C, Scillia P, Cassart M, Lamotte M, Knoop C, Melot C, Estenne M. Preferential reduction of quadriceps over respiratory muscle strength and bulk after lung transplantation for cystic fibrosis. Thorax. 2004 Sep;59(9):783-9. doi: 10.1136/thx.2004.021766.</citation>
    <PMID>15333856</PMID>
  </results_reference>
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    <citation>Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.</citation>
    <PMID>7154893</PMID>
  </results_reference>
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    <citation>O'Donovan C, Greally P, Canny G, McNally P, Hussey J. Active video games as an exercise tool for children with cystic fibrosis. J Cyst Fibros. 2014 May;13(3):341-6. doi: 10.1016/j.jcf.2013.10.008. Epub 2013 Nov 1.</citation>
    <PMID>24189057</PMID>
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    <citation>American College of Sports Medicine Position Stand. The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc. 1998 Jun;30(6):975-91. doi: 10.1097/00005768-199806000-00032.</citation>
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    <citation>Rand S, Hill L, Prasad SA. Physiotherapy in cystic fibrosis: optimising techniques to improve outcomes. Paediatr Respir Rev. 2013 Dec;14(4):263-9. doi: 10.1016/j.prrv.2012.08.006. Epub 2012 Nov 4.</citation>
    <PMID>24209461</PMID>
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    <citation>Kuys SS, Hall K, Peasey M, Wood M, Cobb R, Bell SC. Gaming console exercise and cycle or treadmill exercise provide similar cardiovascular demand in adults with cystic fibrosis: a randomised cross-over trial. J Physiother. 2011;57(1):35-40. doi: 10.1016/S1836-9553(11)70005-4.</citation>
    <PMID>21402328</PMID>
  </results_reference>
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    <citation>del Corral T, Percegona J, Seborga M, Rabinovich RA, Vilaro J. Physiological response during activity programs using Wii-based video games in patients with cystic fibrosis (CF). J Cyst Fibros. 2014 Dec;13(6):706-11. doi: 10.1016/j.jcf.2014.05.004. Epub 2014 Jun 13.</citation>
    <PMID>24935613</PMID>
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    <citation>Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.</citation>
    <PMID>23851406</PMID>
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    <citation>Rodrigues AN, Perez AJ, Carletti L, Bissoli NS, Abreu GR. Maximum oxygen uptake in adolescents as measured by cardiopulmonary exercise testing: a classification proposal. J Pediatr (Rio J). 2006 Nov-Dec;82(6):426-30. doi: 10.2223/JPED.1533. Epub 2006 Sep 21.</citation>
    <PMID>17003945</PMID>
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    <citation>Karila C, de Blic J, Waernessyckle S, Benoist MR, Scheinmann P. Cardiopulmonary exercise testing in children: an individualized protocol for workload increase. Chest. 2001 Jul;120(1):81-7. doi: 10.1378/chest.120.1.81.</citation>
    <PMID>11451820</PMID>
  </results_reference>
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    <citation>Higgins LW, Robertson RJ, Kelsey SF, Olson MB, Hoffman LA, Rebovich PJ, Haile L, Orenstein DM. Exercise intensity self-regulation using the OMNI scale in children with cystic fibrosis. Pediatr Pulmonol. 2013 May;48(5):497-505. doi: 10.1002/ppul.22639. Epub 2012 Sep 19.</citation>
    <PMID>22997144</PMID>
  </results_reference>
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    <citation>Hallal PC, Reichert FF, Clark VL, Cordeira KL, Menezes AM, Eaton S, Ekelund U, Wells JC. Energy expenditure compared to physical activity measured by accelerometry and self-report in adolescents: a validation study. PLoS One. 2013 Nov 4;8(11):e77036. doi: 10.1371/journal.pone.0077036. eCollection 2013.</citation>
    <PMID>24223707</PMID>
  </results_reference>
  <results_reference>
    <citation>Evenson KR, Catellier DJ, Gill K, Ondrak KS, McMurray RG. Calibration of two objective measures of physical activity for children. J Sports Sci. 2008 Dec;26(14):1557-65. doi: 10.1080/02640410802334196.</citation>
    <PMID>18949660</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pontificia Universidade Católica do Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Marcio Vinicius Fagundes Donadio</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>cystic fibrosis</keyword>
  <keyword>video games</keyword>
  <keyword>exercise</keyword>
  <keyword>maximal oxygen consumption</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229213
org study id: game
nct id: NCT03229213
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
measure: Maximal oxygen consumption
time frame: Immediately after test or game
description: Maximal oxygen consumption will be assessed during a maximal cardiopulmonary exercise test and during de use of interactive video games.
measure: Maximal heart rate
time frame: Immediately after test or game
description: Maximal heart rate will be measured using a heart monitor
measure: Satisfaction
time frame: Immediately after games
description: Satisfaction will be evaluated using a 5 point likert scale where 1 represents no satisfaction and 5 much satisfaction.
measure: Physical activity levels
time frame: Immediately after games
description: Physical activity levels will be evaluated using the accelerometer on the left side of the waist.
measure: Subjective evaluation of dyspnea
time frame: Immediately after test or game
description: Dyspnea will be evaluated using the modified BORG scale where 0 is no dyspnea and 10 is maximal dyspnea.
measure: Perception of fatigue
time frame: Immediately after games
description: Perception of fatigue will be evaluated using the OMNI scale where 0 is very easy and 10 is very difficult.
measure: The peripheral oxygen saturation (SpO2)
time frame: Immediately after test or game
description: The peripheral oxygen saturation will be evaluated using a pulse oximetry.
measure: Maximal ventilation (VEmax)
time frame: Immediately after test or game
description: Maximal ventilation (VEmax) will be evaluated using a computerized system coupled to a gas analyzer.
measure: Respiratory quotient (RQ)
time frame: Immediately after test or game
description: The respiratory quotient (RQ) will be evaluated using a computerized system coupled to a gas analyzer.
measure: Metabolic equivalents for oxygen (VE/VO2)
time frame: Immediately after test or game
description: Metabolic equivalents for oxygen will be evaluated using a computerized system coupled to a gas analyzer.
measure: Metabolic equivalents for carbon dioxide (VE/VCO2)
time frame: Immediately after test or game
description: Metabolic equivalents for carbon dioxide Metabolic equivalents for oxygen will be evaluated using a computerized system coupled to a gas analyzer.
arm group label: Cystic Fibrosis
description: Cystic fibrosis patients will be invited to participate in the study. All participants will complete a questionnaire to assess the level of physical activity prior to evaluation. On the first visit they will perform the cardiopulmonary exercise test (CPET) to evaluate cardiorespiratory responses during exercise. On the second visit an evaluation of the cardiorespiratory responses during the use of interactive video games (Nintendo Wii or Xbox One) will be performed. During interactive games, participants will use an accelerometer to assess the level of physical activity.
arm group label: Healthy
description: Healthy subjects will be invited to participate in the study. All participants will complete a questionnaire to assess the level of physical activity prior to evaluation. On the first visit they will perform the cardiopulmonary exercise test (CPET) to evaluate cardiorespiratory responses during exercise. On the second visit an evaluation of the cardiorespiratory responses during the use of interactive video games (Nintendo Wii or Xbox One) will be performed. During interactive games, participants will use an accelerometer to assess the level of physical activity.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcio Donadio, PhD
role: Principal Investigator
affiliation: Pontificia Universidade Católica do Rio Grande do Sul
facility: 
country: Brazil
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responsible party type: Principal Investigator
investigator affiliation: Pontificia Universidade Católica do Rio Grande do Sul
investigator full name: Marcio Vinicius Fagundes Donadio
investigator title: Professor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No