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OpenTrials
Completed

NCT Number: NCT02277860

Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

Physical activity and exercise have become an accepted and valued component of cystic fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised, facility-based exercise programs are expensive and labor intensive (since groups of patients with CF cannot exercise together in the same physical location). Home-based exercise using an interactive exergame device may be an effective way to improve adherence to an exercise program for patients with CF. Therefore, the primary objective of this study is to evaluate the effects of a 12-week, home-based exergame exercise intervention on aerobic capacity (peak VO2). The secondary endpoint is nasal potential difference, an indicator of how well sodium and chloride flow across the mucous membranes in the nose. Other outcomes include patient-reported quality of life and habitual physical activity level. Following baseline assessments participants will be begin a 12 week, partially-supervised exercise program consisting of at least 90 minutes per week of aerobic and resistance exercise training using the Nintendo Wii Fit Plus exergaming device. Participants will receive at least monthly follow-up phone calls to provide additional exercise counseling and motivation. After 12 weeks, they will continue with the exergame intervention for another 12 weeks, but without external supervision.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-1212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed diagnosis of CF
  • currently sedentary (<60 min/week of physical activity)
  • stable clinical condition (no exacerbation in last 6 weeks)

Exclusion criteria

  • nasal surgery for polyposis in the past 2 years
  • participating or have participated (in the past 30 days) in another clinical trial which can affect the outcomes of the proposed study
  • unable to read/speak English
  • recurrent pneumothorax (in the past 6 months)
  • hemoptysis (hospitalized in the past 6 months)
  • uncontrolled CF-related diabetes (HbA1c > 10%)

Treatment and study plan

Exercise

Behavioral

Aerobic and strength training using the Wii Fit for ≥ 30 min, ≥3 days/week, for 12 weeks, at a moderate intensity (Borg CR10 3-5).

Primary outcomes

  1. Peak oxygen consumption (VO2 peak)

    Time frame: 12 and 24 weeks

    Measure of aerobic physical fitness

Secondary outcomes

  1. Nasal potential difference (NPD)

    Time frame: 12 weeks

    Measure of respiratory/airway ion transport

  2. Cystic Fibrosis Questionnaire-Revised (CFQ-R))

    Time frame: 12 and 24 weeks

    Health-related quality of life questionnaire (especially respiratory-related symptoms)

  3. Habitual physical activity level

    Time frame: 12 and 24 weeks

    Accelerometer-based measure of frequency, intensity and duration of bouts of physical activity while user is wearing device.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2014
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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