Clinical trial NCT02277860: Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis
Official title: Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Exercise
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%)

Primary outcomes:
measure: Peak oxygen consumption (VO2 peak)
timeFrame: 12 and 24 weeks
Secondary outcomes:
measure: Nasal potential difference (NPD)
timeFrame: 12 weeks
measure: Cystic Fibrosis Questionnaire-Revised (CFQ-R))
timeFrame: 12 and 24 weeks
measure: Habitual physical activity level
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: John D Lowman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lowman JD, Solomon GM, Rowe SM, Yuen HK. Gaming Console Home-Based Exercise for Adults with Cystic Fibrosis: Study Protocol. Int J Caring Sci. 2020 Spring/Summer;13(2):1530-1540.