Clinical trial NCT03229213: Interactive Video Game Responses in Cystic Fibrosis
Official title: Evaluation of Physiological Responses During the Use of Interactive Video Game and the Cardiopulmonary Exercise Test in Cystic Fibrosis and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
video games
exercise
maximal oxygen consumption
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 55
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Maximal oxygen consumption
timeFrame: Immediately after test or game
measure: Maximal heart rate
timeFrame: Immediately after test or game
Secondary outcomes:
measure: Satisfaction
timeFrame: Immediately after games
measure: Physical activity levels
timeFrame: Immediately after games
measure: Subjective evaluation of dyspnea
timeFrame: Immediately after test or game
measure: Perception of fatigue
timeFrame: Immediately after games
measure: The peripheral oxygen saturation (SpO2)
timeFrame: Immediately after test or game
measure: Maximal ventilation (VEmax)
timeFrame: Immediately after test or game
measure: Respiratory quotient (RQ)
timeFrame: Immediately after test or game
measure: Metabolic equivalents for oxygen (VE/VO2)
timeFrame: Immediately after test or game
measure: Metabolic equivalents for carbon dioxide (VE/VCO2)
timeFrame: Immediately after test or game
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pontifífia Universidade Católica do Rio Grande do Sul
state: RS
Study officials:
affiliation: Pontificia Universidade Católica do Rio Grande do Sul
name: Marcio Donadio, PhD
role: PRINCIPAL_INVESTIGATOR
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