Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Exercise
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%)
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
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).
Outcomes
Primary Outcome Measures
Peak oxygen consumption (VO2 peak)
Measure of aerobic physical fitness
Secondary Outcome Measures
Nasal potential difference (NPD)
Measure of respiratory/airway ion transport
Cystic Fibrosis Questionnaire-Revised (CFQ-R))
Health-related quality of life questionnaire (especially respiratory-related symptoms)
Habitual physical activity level
Accelerometer-based measure of frequency, intensity and duration of bouts of physical activity while user is wearing device.
Full Information
NCT ID
NCT02277860
First Posted
October 27, 2014
Last Updated
March 8, 2018
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02277860
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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 Outcome Measure Information:
Title
Peak oxygen consumption (VO2 peak)
Description
Measure of aerobic physical fitness
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Nasal potential difference (NPD)
Description
Measure of respiratory/airway ion transport
Time Frame
12 weeks
Title
Cystic Fibrosis Questionnaire-Revised (CFQ-R))
Description
Health-related quality of life questionnaire (especially respiratory-related symptoms)
Time Frame
12 and 24 weeks
Title
Habitual physical activity level
Description
Accelerometer-based measure of frequency, intensity and duration of bouts of physical activity while user is wearing device.
Time Frame
12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Lowman, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-1212
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33163109
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.
Results Reference
derived
Learn more about this trial
Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis
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