Interactive Video Game Responses in Cystic Fibrosis

NCT03229213 | Completed

• 1 other identifier: game
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; video games; exercise; maximal oxygen consumption

Outcome Measures

Primary Outcomes (2)

• Maximal oxygen consumption

  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

  Maximal heart rate will be measured using a heart monitor

  Immediately after test or game

Secondary Outcomes (9)

• Satisfaction

  Immediately after games

• Physical activity levels

  Immediately after games

• Subjective evaluation of dyspnea

  Immediately after test or game

• Perception of fatigue

  Immediately after games

• The peripheral oxygen saturation (SpO2)

  Immediately after test or game

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

Study Sites (1)

Pontifífia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

Related Publications (24)

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MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• Marcio Donadio, PhD

  Pontificia Universidade Católica do Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 25, 2017
• Study Start: August 30, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)