Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277860
• Other study ID #: F120307002
• Status: Completed
• Phase: N/A
• First received: October 27, 2014
• Last updated: March 8, 2018
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Exercise
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).

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen consumption (VO2 peak)	Measure of aerobic physical fitness	12 and 24 weeks
Secondary	Nasal potential difference (NPD)	Measure of respiratory/airway ion transport	12 weeks
Secondary	Cystic Fibrosis Questionnaire-Revised (CFQ-R))	Health-related quality of life questionnaire (especially respiratory-related symptoms)	12 and 24 weeks
Secondary	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