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

An observational study of Cystic Fibrosis, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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) Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Cystic Fibrosis
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2019to 24 Aug 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Cystic fibrosis patients seen at an academic adult CF center.

Who may be able to join

Adults with Cystic Fibrosis
Age >18, Cystic Fibrosis

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53202

Other trials in United States

About this study

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

Read the detailed description

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.

Conditions: Cystic Fibrosis
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04018495
Study group	Role	What they receive
CF patients using Fitbit for 3 months		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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Activity Tracker Utilization- Total Days of Use
Descriptive statistics, such as mean for the number of days of use over the three month period
Measured: 3 months
Activity Tracker Utilization - Minutes of Sleep Per Night
Descriptive statistics, such as mean for the number of minutes per sleep per night
Measured: 3 months
Activity Tracker Utilization - Steps Per Day
Descriptive statistics, such as mean, for the number of steps per day
Measured: 3 months

Secondary outcomes (1)

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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201924 Aug 2022

First posted12 Jul 2019
Study start10 Sep 2019
Primary completion24 Aug 2022
Study completion24 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
More trials run by Medical College of WisconsinThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04018495
Sponsor's protocol ID: 34812
Status last verified: Jan 2025
First submitted: 9 Jul 2019
Last updated: 3 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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. doi: 10.1378/chest.128.3.1357.
PubMed 16162729
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.
PubMed 29087960
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. doi: 10.1183/09031936.02.00088702.
PubMed 11936530
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.
PubMed 26158896
Gonzalez-Ortiz M, Martinez-Abundis E, Balcazar-Munoz BR, Pascoe-Gonzalez S. Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects. Diabetes Nutr Metab. 2000 Apr;13(2):80-3.
PubMed 10898125

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)

All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF.
ClinicalTrials.gov ID: NCT04018495
Acronym / sponsor ID: 34812
Conditions: Cystic Fibrosis
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Medical College of WisconsinUniversity, hospital or other
Collaborators: Cystic Fibrosis Foundation
Study start: 10 Sep 2019 (actual)
Primary completion: 24 Aug 2022 (actual)
Study completion: 24 Aug 2022 (actual)
First posted: 12 Jul 2019 (actual)
Results: Posted 3 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
CF patients using Fitbit for 3 months	–	–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.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Cystic fibrosis patients seen at an academic adult CF center.

Key inclusion criteria (2 listed)

Adults with Cystic Fibrosis
Age >18, Cystic Fibrosis

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Activity Tracker Utilization- Total Days of Use
Time frame: 3 months
Descriptive statistics, such as mean for the number of days of use over the three month period
Activity Tracker Utilization - Minutes of Sleep Per Night
Time frame: 3 months
Descriptive statistics, such as mean for the number of minutes per sleep per night
Activity Tracker Utilization - Steps Per Day
Time frame: 3 months
Descriptive statistics, such as mean, for the number of steps per day

1 secondary outcome

Integration of Cystic Fibrosis Registry Lung Function Data - Average GLI FEV1 From First to Last Day of Fitbit Wear
Time frame: 3 months

Results and safety

Results posted to the registry on 3 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CF Patients Using Fitbit for 3 Months	21	20

Primary outcome: Activity Tracker Utilization- Total Days of Use

Time frame: 3 months. Mean (Full Range). Unit: Total days used

Measure	CF Patients Using Fitbit for 3 Months n = 21
Value	85.380 (27 to 93)

Primary outcome: Activity Tracker Utilization - Minutes of Sleep Per Night

Time frame: 3 months. Mean (Full Range). Unit: minutes of sleep per night

Measure	CF Patients Using Fitbit for 3 Months n = 21
Value	381.28 (0 to 983)

Primary outcome: Activity Tracker Utilization - Steps Per Day

Time frame: 3 months. Mean (Full Range). Unit: steps/day

Measure	CF Patients Using Fitbit for 3 Months n = 21
Value	7262.49 (0 to 30010)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interventional - Fitbit Tracker	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16162729Amin 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. doi: 10.1378/chest.128.3.1357.
Background: PubMed 29087960Beattie 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.
Background: PubMed 11936530Dancey 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. doi: 10.1183/09031936.02.00088702.
Background: PubMed 26158896de 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.
Background: PubMed 10898125Gonzalez-Ortiz M, Martinez-Abundis E, Balcazar-Munoz BR, Pascoe-Gonzalez S. Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects. Diabetes Nutr Metab. 2000 Apr;13(2):80-3.
Sample size requirements for estimating Pearson, Kendall and Spearman Correlations. Insufficient sleep is a public health problem. Cystic Fibrosis Trust Cystic Fibrosis Registry ReportLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Cystic Fibrosis

RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rose Franco, MD principal investigator

Medical College of Wisconsin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cystic Fibrosis, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Activity Tracker Utilization- Total Days of Use (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04018495, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.