STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018495
• Other study ID #: 34812
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: August 24, 2022

Study information

• Verified date: August 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF. A pilot in integration of wearable fitness tracker data with existing health data provided by CF foundation Patient Registry (Port CF)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adults with Cystic Fibrosis

• Age >18, Cystic Fibrosis

Exclusion Criteria:

• A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.

• Those unable to commit to at least 3 months follow up for CF care from enrollment at study CF center. Inability to speak and understand English.

• Those patients without dedicated access to a smartphone, tablet, or computer with internet for syncing device and completing patient diary.

• Those patients unwilling to sign an informed consent form.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Fitbit Tracker
Fitbit tracker; is an activity tracking product that is wireless-enabled wearable technology device that measures data such as the number of steps walked, heart rate, quality of sleep, steps climbed, and other personal metrics involved in fitness

Locations

Country	Name	City	State
United States	Medical College of Wisconsin/Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

References & Publications (5)

Amin R, Bean J, Burklow K, Jeffries J. The relationship between sleep disturbance and pulmonary function in stable pediatric cystic fibrosis patients. Chest. 2005 Sep;128(3):1357-63. — View Citation

Beattie Z, Oyang Y, Statan A, Ghoreyshi A, Pantelopoulos A, Russell A, Heneghan C. Estimation of sleep stages in a healthy adult population from optical plethysmography and accelerometer signals. Physiol Meas. 2017 Oct 31;38(11):1968-1979. doi: 10.1088/1361-6579/aa9047. — View Citation

Dancey DR, Tullis ED, Heslegrave R, Thornley K, Hanly PJ. Sleep quality and daytime function in adults with cystic fibrosis and severe lung disease. Eur Respir J. 2002 Mar;19(3):504-10. — View Citation

de Zambotti M, Baker FC, Colrain IM. Validation of Sleep-Tracking Technology Compared with Polysomnography in Adolescents. Sleep. 2015 Sep 1;38(9):1461-8. doi: 10.5665/sleep.4990. — View Citation

González-Ortiz M, Martínez-Abundis E, Balcázar-Muñoz BR, Pascoe-González S. Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects. Diabetes Nutr Metab. 2000 Apr;13(2):80-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trends of FEV1 will be measured	Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Forced Expiratory Volume (FEV1) will be measured pre and post use of Fitbit.	1 year
Other	Trends of BMI will be measured	Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Body mass index (BMI) per pounds will be measured pre and post Fitbit.	1 year
Other	Trends exacerbation rates will be measured	Analyze the data trends from the Fitbit for activity and sleep with health trends from the CFFPR. Exacerbation symptoms and rates will be measured pre and post Fitbit.	1 year
Primary	Participants will Consistently Use Fitbit Tracker	Demonstrate that participants will consistently use and upload data from the fitness tracker as measured by use of at least 20 hours per day and uploading of at least 75% of activity.	1 year
Secondary	Integration Tool Development	Develop integration tool for the data from the Fitbit with data from Cystic Fibrosis Foundation Patient Registry.	1 year

External Links

•   Sample size requirements for estimating Pearson, Kendall and Spearman Correlations. Insufficient sleep is a public health problem. Cystic Fibrosis Trust Cystic Fibrosis Registry Report