Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Fitbit

• Registration Number: NCT02700243
• Lead Sponsor: Boston Children's Hospital

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-02-21
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Study Start: 2016-03-14
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. A diagnosis of Cystic Fibrosis
2. Age 18 and over
3. Must be able to complete at least level 1 of the baseline exercise fitness test
4. Must not have required IV antibiotics for a CF exacerbation within 30 days of starting the program

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Exclusion Criteria

1. Pregnancy at enrollment
2. A history of CF exacerbation requiring IV antibiotics within last month
3. Use of a fitness tracker or similar product within 6 months of enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fitbit	Fitbit	Participants receive a Fitbit and are followed over the course of one year, completing surveys and exercise tests.

Primary Outcome Measures

Name	Time	Method
Graded exercise test (Submaximal GXT)	Two years (Enrollment, 6 months, 12 months, 24 months)	Change is submaximal GXT will be assessed for all participants

Secondary Outcome Measures

Name	Time	Method
Fitbit activity data	Two years
Relative change from baseline in ppFEV1	Two years	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.
Overall qualitative assessment of participant's potential barriers to Fitbit use	Two years (6 Month Time Point)	Qualitative data obtained by open-ended interview
Relative change from baseline in ppFEF25-75	Two years	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.
Overall qualitative assessment of the participant's use of the social media associated with the device	Two years (6 Month Time Point)	Qualitative data obtained by open-ended interview
HAES (Habitual Activity Estimation Scale)	Two years
Relative change from baseline in ppFVC	Two years	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.
CFQ-R (Survey on Quality of Life in Cystic Fibrosis)	Two years
Overall qualitative assessment of participant satisfaction with the Fitbit	Two years (6 Month Time Point)	Qualitative data obtained by open-ended interview
Incidence of exacerbations requiring IV antibiotics	Two years
GAD-7	Two years (Enrollment, 6 months, 12 months, 18 months, 24 months)	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.
PHQ9	Two years (Enrollment, 6 months, 12 months, 18 months, 24 months)	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.
BMI	Two years