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Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277860
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
John D Lowman, PT, PhD, 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis
Study Start Date : May 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: 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).
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).




Primary Outcome Measures :
  1. Peak oxygen consumption (VO2 peak) [ Time Frame: 12 and 24 weeks ]
    Measure of aerobic physical fitness


Secondary Outcome Measures :
  1. Nasal potential difference (NPD) [ Time Frame: 12 weeks ]
    Measure of respiratory/airway ion transport

  2. Cystic Fibrosis Questionnaire-Revised (CFQ-R)) [ Time Frame: 12 and 24 weeks ]
    Health-related quality of life questionnaire (especially respiratory-related symptoms)

  3. Habitual physical activity level [ Time Frame: 12 and 24 weeks ]
    Accelerometer-based measure of frequency, intensity and duration of bouts of physical activity while user is wearing device.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277860


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-1212
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: John D Lowman, PhD University of Alabama at Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John D Lowman, PT, PhD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02277860    
Other Study ID Numbers: F120307002
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Keywords provided by John D Lowman, PT, PhD, University of Alabama at Birmingham:
Exercise
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases