Cystic FibrosisINTERACTNCT02700243
Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial
A study testing Fitbit in people with Cystic Fibrosis, run by Boston Children's Hospital.
Trial summary
In this research study the investigators want to learn more about whether using a fitness tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and in turn whether it increases exercise tolerance over the period of one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Cystic Fibrosis
- Age 18 and over
- Must be able to complete at least level 1 of the baseline exercise fitness test
- Must not have required IV antibiotics for a CF exacerbation within 30 days of starting the program
Who cannot join
- Pregnancy at enrollment
- A history of CF exacerbation requiring IV antibiotics within last month
- Use of a fitness tracker or similar product within 6 months of enrollment
About this study
Official title: Pilot RCT Study Using a Fitbit Device to Improve Exercise Tolerance in 80 Patients With Cystic Fibrosis
In this research study the investigators want to learn more about whether using a fitness tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and in turn whether it increases exercise tolerance over the period of one year.
Read the detailed description
The aim of this study is to evaluate whether the use of a Fitbit device and an exercise prescription is associated with increased daily activity and in turn increased exercise tolerance in young adult patients with cystic fibrosis (CF). The investigators hypothesize that use of the Fitbit and an exercise prescription will be associated with increased exercise tolerance compared to standard counseling and an exercise prescription alone.
For patients with CF, young adulthood and adolescence is a significant time of vulnerability. In addition to normal behavioral challenges of adolescence and young adulthood (seeking independence/autonomy while also choosing rebellion), those with CF are often dealing with significant disease progression. Therefore, working in new innovative ways to improve adherence to regimens that improve lung function such as exercise are needed to continue to support patients during this vulnerable time.
Studies of patients with cystic fibrosis have shown that regular exercise training can decrease rate of lung function decline, potentially improve lung function, and improve aerobic capacity. However, many patients do not include regular exercise in their daily routine. Successful strategies to improve adherence include providing patient specific guidelines for an appropriate exercise program, supporting participation and providing positive feedback. Overall, exercise is a crucial diagnostic and therapeutic modality for patients with Cystic Fibrosis, although awareness somewhat limited. The adult CF program at Boston Children's and Brigham \& Women's Hospital established an inpatient and outpatient exercise program as part of a quality improvement effort. Patients are prescribed an individualized exercise program or exercise prescription based on their assessment during a sub-maximal effort. This program has been successful but given the rigors of daily life (e.g. school, work, family obligations), adherence is a concern with resources limiting more rigorous feedback to maintain this essential life activity.
- Conditions
- Cystic Fibrosis
- Being tested
- Fitbit
- Keywords
- Cystic Fibrosis, Exercise, Fitbit
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitBehavioural
Participants receive a Fitbit and are followed over the course of one year to determine use and health outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Fitbit | Experimental | Participants receive a Fitbit and are followed over the course of one year, completing surveys and exercise tests. Receives: Behavioral: Fitbit |
| Usual Care | No intervention | Participants receive usual care over the course of one year and are offered a Fitbit in the second year. Followed to assess use of Fitbit and health outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graded exercise test (Submaximal GXT)
Change is submaximal GXT will be assessed for all participants
Measured: Two years (Enrollment, 6 months, 12 months, 24 months)
Secondary outcomes (13)
Fitbit activity data
Measured: Two years
HAES (Habitual Activity Estimation Scale)
Measured: Two years
Relative change from baseline in ppFEV1
Forced Expiratory Volume in one second (FEV1) from before study (Baseline) to each data collection timepoint, and from one data collection timepoint to the next.
Measured: Two years
Relative change from baseline in ppFVC
Forced Vital Capacity in one second (FVC) from before study (Baseline) to each data collection timepoint, and from one data collection timepoint to the next.
Measured: Two years
Relative change from baseline in ppFEF25-75
Forced Expiratory Flow in one second (FEF25-75) from before study (Baseline) to each data collection timepoint, and from one data collection timepoint to the next.
Measured: Two years
Incidence of exacerbations requiring IV antibiotics
Measured: Two years
BMI
Measured: Two years
CFQ-R (Survey on Quality of Life in Cystic Fibrosis)
Measured: Two years
Overall qualitative assessment of participant satisfaction with the Fitbit
Qualitative data obtained by open-ended interview
Measured: Two years (6 Month Time Point)
Overall qualitative assessment of participant's potential barriers to Fitbit use
Qualitative data obtained by open-ended interview
Measured: Two years (6 Month Time Point)
Overall qualitative assessment of the participant's use of the social media associated with the device
Qualitative data obtained by open-ended interview
Measured: Two years (6 Month Time Point)
PHQ9
Depression scale scored 0-27, with a score of 0-4 indicating minimal risk for depression/anxiety, a score of 5-9 indicating mild risk for depression/anxiety, a score of 10-14 indicating moderate risk for depression/anxiety, and a score if 15-27 indicating severe risk for depression/anxiety.
Measured: Two years (Enrollment, 6 months, 12 months, 18 months, 24 months)
GAD-7
Depression scale scored 0-21, with a score of 0-4 indicating minimal risk for depression/anxiety, a score of 5-9 indicating mild risk for depression/anxiety, a score of 10-14 indicating moderate risk for depression/anxiety, and a score if 15-21 indicating severe risk for depression/anxiety.
Measured: Two years (Enrollment, 6 months, 12 months, 18 months, 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start14 Mar 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Uluer, Boston Children's Hospital
- Investigators
- Ahmet Uluer, DO, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700243
- Sponsor's protocol ID
- IRB-P00012871
- Acronym
- INTERACT
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2016
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Participants will receive their graded exercise test scores as part of their clinical care and will be able to see their individual data relating to Fitbit on their own device.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT Study Using a Fitbit Device to Improve Exercise Tolerance in 80 Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02700243
- Acronym / sponsor ID
- INTERACT / IRB-P00012871
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Exercise, Fitbit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study the investigators want to learn more about whether using a fitness tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and in turn whether it increases exercise tolerance over the period of one year.
Detailed description
The aim of this study is to evaluate whether the use of a Fitbit device and an exercise prescription is associated with increased daily activity and in turn increased exercise tolerance in young adult patients with cystic fibrosis (CF). The investigators hypothesize that use of the Fitbit and an exercise prescription will be associated with increased exercise tolerance compared to standard counseling and an exercise prescription alone.
For patients with CF, young adulthood and adolescence is a significant time of vulnerability. In addition to normal behavioral challenges of adolescence and young adulthood (seeking independence/autonomy while also choosing rebellion), those with CF are often dealing with significant disease progression. Therefore, working in new innovative ways to improve adherence to regimens that improve lung function such as exercise are needed to continue to support patients during this vulnerable time.
Studies of patients with cystic fibrosis have shown that regular exercise training can decrease rate of lung function decline, potentially improve lung function, and improve aerobic capacity. However, many patients do not include regular exercise in their daily routine. Successful strategies to improve adherence include providing patient specific guidelines for an appropriate exercise program, supporting participation and providing positive feedback. Overall, exercise is a crucial diagnostic and therapeutic modality for patients with Cystic Fibrosis, although awareness somewhat limited. The adult CF program at Boston Children's and Brigham \& Women's Hospital established an inpatient and outpatient exercise program as part of a quality improvement effort. Patients are prescribed an individualized exercise program or exercise prescription based on their assessment during a sub-maximal effort. This program has been successful but given the rigors of daily life (e.g. school, work, family obligations), adherence is a concern with resources limiting more rigorous feedback to maintain this essential life activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit | Experimental | Behavioral: FitbitParticipants receive a Fitbit and are followed over the course of one year, completing surveys and exercise tests. |
| Usual Care | No intervention | –Participants receive usual care over the course of one year and are offered a Fitbit in the second year. Followed to assess use of Fitbit and health outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of Cystic Fibrosis
- Age 18 and over
- Must be able to complete at least level 1 of the baseline exercise fitness test
- Must not have required IV antibiotics for a CF exacerbation within 30 days of starting the program
Key exclusion criteria (3 listed)
- Pregnancy at enrollment
- A history of CF exacerbation requiring IV antibiotics within last month
- Use of a fitness tracker or similar product within 6 months of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitParticipants receive a Fitbit and are followed over the course of one year to determine use and health outcomes. | Behavioural | Fitbit |
Primary outcome
Graded exercise test (Submaximal GXT)
Time frame: Two years (Enrollment, 6 months, 12 months, 24 months)
Change is submaximal GXT will be assessed for all participants
13 secondary outcomes
Fitbit activity data
Time frame: Two years
HAES (Habitual Activity Estimation Scale)
Time frame: Two years
Relative change from baseline in ppFEV1
Time frame: Two years
Relative change from baseline in ppFVC
Time frame: Two years
Relative change from baseline in ppFEF25-75
Time frame: Two years
Incidence of exacerbations requiring IV antibiotics
Time frame: Two years
BMI
Time frame: Two years
CFQ-R (Survey on Quality of Life in Cystic Fibrosis)
Time frame: Two years
Overall qualitative assessment of participant satisfaction with the Fitbit
Time frame: Two years (6 Month Time Point)
Overall qualitative assessment of participant's potential barriers to Fitbit use
Time frame: Two years (6 Month Time Point)
Overall qualitative assessment of the participant's use of the social media associated with the device
Time frame: Two years (6 Month Time Point)
PHQ9
Time frame: Two years (Enrollment, 6 months, 12 months, 18 months, 24 months)
GAD-7
Time frame: Two years (Enrollment, 6 months, 12 months, 18 months, 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. Participants will receive their graded exercise test scores as part of their clinical care and will be able to see their individual data relating to Fitbit on their own device.
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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.
Ahmet Uluer, DO principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit in people with Cystic Fibrosis, run by Boston Children's Hospital.
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 4 inclusion and 3 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Graded exercise test (Submaximal GXT) (time frame: Two years (Enrollment, 6 months, 12 months, 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.