Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Official Title
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Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Aerobic and strength training using the Wii Fit Plus for ≥ 30 min, ≥3 days/week, for 12 weeks, at a moderate intensity (Borg CR10 3-5). | Behavioral: Exercise<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen consumption (VO2 peak) | Measure of aerobic physical fitness | 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal potential difference (NPD) | Measure of respiratory/airway ion transport | 12 weeks | 
| Cystic Fibrosis Questionnaire-Revised (CFQ-R)) | Health-related quality of life questionnaire (especially respiratory-related symptoms) | 12 and 24 weeks | 
| Habitual physical activity level | Accelerometer-based measure of frequency, intensity and duration of bouts of physical activity while user is wearing device. | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise