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Interactive Video Game Responses in Cystic Fibrosis (Igamecf)

24 februari 2020 bijgewerkt door: Marcio Vinicius Fagundes Donadio, Pontificia Universidade Católica do Rio Grande do Sul

Evaluation of Physiological Responses During the Use of Interactive Video Game and the Cardiopulmonary Exercise Test in Cystic Fibrosis and Healthy Individuals

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

55

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • RS
      • Porto Alegre, RS, Brazilië, 90619-900
        • Pontifífia Universidade Católica do Rio Grande do Sul

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar tot 30 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with cystic fibrosis, recruited at the CF center of Hospital São Lucas (PUCRS), and healthy individuals recruited from the loccal community.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximal oxygen consumption
Tijdsspanne: 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.
Immediately after test or game
Maximal heart rate
Tijdsspanne: Immediately after test or game
Maximal heart rate will be measured using a heart monitor
Immediately after test or game

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Satisfaction
Tijdsspanne: Immediately after games
Satisfaction will be evaluated using a 5 point likert scale where 1 represents no satisfaction and 5 much satisfaction.
Immediately after games
Physical activity levels
Tijdsspanne: Immediately after games
Physical activity levels will be evaluated using the accelerometer on the left side of the waist.
Immediately after games
Subjective evaluation of dyspnea
Tijdsspanne: Immediately after test or game
Dyspnea will be evaluated using the modified BORG scale where 0 is no dyspnea and 10 is maximal dyspnea.
Immediately after test or game
Perception of fatigue
Tijdsspanne: Immediately after games
Perception of fatigue will be evaluated using the OMNI scale where 0 is very easy and 10 is very difficult.
Immediately after games
The peripheral oxygen saturation (SpO2)
Tijdsspanne: Immediately after test or game
The peripheral oxygen saturation will be evaluated using a pulse oximetry.
Immediately after test or game
Maximal ventilation (VEmax)
Tijdsspanne: Immediately after test or game
Maximal ventilation (VEmax) will be evaluated using a computerized system coupled to a gas analyzer.
Immediately after test or game
Respiratory quotient (RQ)
Tijdsspanne: Immediately after test or game
The respiratory quotient (RQ) will be evaluated using a computerized system coupled to a gas analyzer.
Immediately after test or game
Metabolic equivalents for oxygen (VE/VO2)
Tijdsspanne: Immediately after test or game
Metabolic equivalents for oxygen will be evaluated using a computerized system coupled to a gas analyzer.
Immediately after test or game
Metabolic equivalents for carbon dioxide (VE/VCO2)
Tijdsspanne: 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.
Immediately after test or game

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Marcio Donadio, PhD, Pontificia Universidade Católica do Rio Grande do Sul

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 augustus 2017

Primaire voltooiing (Werkelijk)

31 maart 2019

Studie voltooiing (Werkelijk)

31 maart 2019

Studieregistratiedata

Eerst ingediend

21 juli 2017

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2017

Eerst geplaatst (Werkelijk)

25 juli 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 februari 2020

Laatste update ingediend die voldeed aan QC-criteria

24 februari 2020

Laatst geverifieerd

1 februari 2020

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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