Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Exercise

• Registration Number: NCT02277860
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-29
• Study Start: 2015-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

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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%)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	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).

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption (VO2 peak)	12 and 24 weeks	Measure of aerobic physical fitness

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States