An observational study in Cystic Fibrosis, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Medical College of Wisconsin · Observational
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)
Cystic fibrosis patients who are willing to use an activity tracker for 3 months are invited to participate. Analysis of activity patterns and sleep patterns will be analyzed and compared to their lung function and general health as part of the routine CF center care visits during the study period.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 21 is below the median of 85 across 482 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cystic fibrosis patients seen at an academic adult CF center.
Exclusion Criteria:
CF patients at time of enrollment who are willing to use a fitbit tracker to measure activity and sleep during the observational period of 3 months.
Activity Tracker Utilization- Total Days of Use
Descriptive statistics, such as mean for the number of days of use over the three month period
Time frame: 3 months
Activity Tracker Utilization - Minutes of Sleep Per Night
Descriptive statistics, such as mean for the number of minutes per sleep per night
Time frame: 3 months
Activity Tracker Utilization - Steps Per Day
Descriptive statistics, such as mean, for the number of steps per day
Time frame: 3 months
Integration of Cystic Fibrosis Registry Lung Function Data - Average GLI FEV1 From First to Last Day of Fitbit Wear
Analyze the data trends. Forced Expiratory Volume (FEV1) reported will be used for small group analysis to compare trends with lung function mean from first to last day of wear.
Time frame: 3 months
| Milestone | CF Patients Using Fitbit for 3 Months |
|---|---|
| Started | 21 |
| Completed | 20 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
Descriptive statistics, such as mean for the number of days of use over the three month period
| Total days used | CF Patients Using Fitbit for 3 Months |
|---|---|
| Activity Tracker Utilization- Total Days of Use | 85.380 (27 to 93) |
Descriptive statistics, such as mean for the number of minutes per sleep per night
| minutes of sleep per night | CF Patients Using Fitbit for 3 Months |
|---|---|
| Activity Tracker Utilization - Minutes of Sleep Per Night | 381.28 (0 to 983) |
Descriptive statistics, such as mean, for the number of steps per day
| steps/day | CF Patients Using Fitbit for 3 Months |
|---|---|
| Activity Tracker Utilization - Steps Per Day | 7262.49 (0 to 30010) |
Analyze the data trends. Forced Expiratory Volume (FEV1) reported will be used for small group analysis to compare trends with lung function mean from first to last day of wear.
| Percentage of Predicted FEV1 | CF Patients Using Fitbit for 3 Months |
|---|---|
| Integration of Cystic Fibrosis Registry Lung Function Data - Average GLI FEV1 From First to Last Day of Fitbit Wear | 66.535 (30.42 to 117.69) |
Collected over 3 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interventional - Fitbit Tracker | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | CF Patients Using Fitbit for 3 Months |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Age, Continuous(years) | CF Patients Using Fitbit for 3 Months |
|---|---|
| Mean | 33 ± 8 |
| Sex: Female, Male(Participants) | CF Patients Using Fitbit for 3 Months |
|---|---|
| Female | 13 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | CF Patients Using Fitbit for 3 Months |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | CF Patients Using Fitbit for 3 Months |
|---|---|
| United States | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin