Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

NCT ID: NCT02277860

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Exercise

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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%)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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John D Lowman, PT, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John D Lowman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33163109 (View on PubMed)

Other Identifiers

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F120307002

Identifier Type: -

Identifier Source: org_study_id

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