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Interactive Video Game Responses in Cystic Fibrosis (Igamecf)

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ClinicalTrials.gov Identifier: NCT03229213
Recruitment Status : Unknown
Verified September 2017 by Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul.
Recruitment status was:  Enrolling by invitation
First Posted : July 25, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul

Brief 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.

Condition or disease
Cystic Fibrosis

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.


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Study Type : Observational
Estimated Enrollment : 68 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Physiological Responses During the Use of Interactive Video Game and the Cardiopulmonary Exercise Test in Cystic Fibrosis and Healthy Individuals
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Group/Cohort
Cystic Fibrosis
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.
Healthy
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.



Primary Outcome Measures :
  1. Maximal oxygen consumption [ Time Frame: Immediately after test or game ]
    Maximal oxygen consumption will be assessed during a maximal cardiopulmonary exercise test and during de use of interactive video games.

  2. Maximal heart rate [ Time Frame: Immediately after test or game ]
    Maximal heart rate will be measured using a heart monitor


Secondary Outcome Measures :
  1. Satisfaction [ Time Frame: Immediately after games ]
    Satisfaction will be evaluated using a 5 point likert scale where 1 represents no satisfaction and 5 much satisfaction.

  2. Physical activity levels [ Time Frame: Immediately after games ]
    Physical activity levels will be evaluated using the accelerometer on the left side of the waist.

  3. Subjective evaluation of dyspnea [ Time Frame: Immediately after test or game ]
    Dyspnea will be evaluated using the modified BORG scale where 0 is no dyspnea and 10 is maximal dyspnea.

  4. Perception of fatigue [ Time Frame: Immediately after games ]
    Perception of fatigue will be evaluated using the OMNI scale where 0 is very easy and 10 is very difficult.

  5. The peripheral oxygen saturation (SpO2) [ Time Frame: Immediately after test or game ]
    The peripheral oxygen saturation will be evaluated using a pulse oximetry.

  6. Maximal ventilation (VEmax) [ Time Frame: Immediately after test or game ]
    Maximal ventilation (VEmax) will be evaluated using a computerized system coupled to a gas analyzer.

  7. Respiratory quotient (RQ) [ Time Frame: Immediately after test or game ]
    The respiratory quotient (RQ) will be evaluated using a computerized system coupled to a gas analyzer.

  8. Metabolic equivalents for oxygen (VE/VO2) [ Time Frame: Immediately after test or game ]
    Metabolic equivalents for oxygen will be evaluated using a computerized system coupled to a gas analyzer.

  9. Metabolic equivalents for carbon dioxide (VE/VCO2) [ Time Frame: Immediately after test or game ]
    Metabolic equivalents for carbon dioxide Metabolic equivalents for oxygen will be evaluated using a computerized system coupled to a gas analyzer.



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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

Cystic fibrosis - clinical diagnosis of cystic fibrosis confirmed by sweat test or genetic test, aged from 6 to 30 years old and presenting stable clinical conditions.

Healthy individuals - to be considered healthy from the application of the health questionnaire and aged from 6 to 30 years old.

Exclusion Criteria:

Patients in both groups who present with cardiopathies, musculoskeletal diseases, neurological diseases or signs of pulmonary exacerbation will be excluded from the study. In addition, those subjects who have difficulty in understanding or are unable to perform the cardiopulmonary exercise test will also be excluded.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229213


Locations
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Brazil
Pontifífia Universidade Católica do Rio Grande do Sul
Porto Alegre, RS, Brazil, 90619-900
Sponsors and Collaborators
Pontificia Universidade Católica do Rio Grande do Sul
Investigators
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Principal Investigator: Marcio Donadio, PhD Pontificia Universidade Católica do Rio Grande do Sul

Publications of Results:

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Responsible Party: Marcio Vinicius Fagundes Donadio, Professor, Pontificia Universidade Católica do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03229213     History of Changes
Other Study ID Numbers: game
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul:
cystic fibrosis
video games
exercise
maximal oxygen consumption
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases