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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fitbit | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit | Behavioral | Participants receive a Fitbit and are followed over the course of one year to determine use and health outcomes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Graded exercise test (Submaximal GXT) | Change is submaximal GXT will be assessed for all participants | Two years (Enrollment, 6 months, 12 months, 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Fitbit activity data | Two years | |
| HAES (Habitual Activity Estimation Scale) | Two years | |
| Relative change from baseline in ppFEV1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Uluer, DO | Boston Children's Hospital | Principal Investigator |
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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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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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. |
| 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. | 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. | Two years |
| Incidence of exacerbations requiring IV antibiotics | Two years |
| BMI | Two years |
| CFQ-R (Survey on Quality of Life in Cystic Fibrosis) | Two years |
| Overall qualitative assessment of participant satisfaction with the Fitbit | Qualitative data obtained by open-ended interview | Two years (6 Month Time Point) |
| Overall qualitative assessment of participant's potential barriers to Fitbit use | Qualitative data obtained by open-ended interview | 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 | 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. | 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. | Two years (Enrollment, 6 months, 12 months, 18 months, 24 months) |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001519 | Behavior |