Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

NCT02277860 | Completed

• 1 other identifier: F120307002
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (VO2 peak)

  Measure of aerobic physical fitness

  12 and 24 weeks

Secondary Outcomes (3)

• Nasal potential difference (NPD)

  12 weeks

• Cystic Fibrosis Questionnaire-Revised (CFQ-R))

  12 and 24 weeks

• Habitual physical activity level

  12 and 24 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

Exercise BEHAVIORAL

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).

Exercise

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-1212, United States

Location

Related Publications (1)

• 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.

  PMID: 33163109 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John D Lowman, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 29, 2014
• Study Start: May 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03

Locations

US (1)