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Completed

NCT Number: NCT02700243

Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Fitbit

Behavioral

Participants receive a Fitbit and are followed over the course of one year to determine use and health outcomes.

Primary outcomes

  1. 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

Secondary outcomes

  1. Fitbit activity data

    Time frame: Two years

  2. HAES (Habitual Activity Estimation Scale)

    Time frame: Two years

  3. Relative change from baseline in ppFEV1

    Time frame: 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.

  4. Relative change from baseline in ppFVC

    Time frame: 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.

  5. Relative change from baseline in ppFEF25-75

    Time frame: 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.

  6. Incidence of exacerbations requiring IV antibiotics

    Time frame: Two years

  7. BMI

    Time frame: Two years

  8. CFQ-R (Survey on Quality of Life in Cystic Fibrosis)

    Time frame: Two years

  9. Overall qualitative assessment of participant satisfaction with the Fitbit

    Time frame: Two years (6 Month Time Point)

    Qualitative data obtained by open-ended interview

  10. Overall qualitative assessment of participant's potential barriers to Fitbit use

    Time frame: Two years (6 Month Time Point)

    Qualitative data obtained by open-ended interview

  11. Overall qualitative assessment of the participant's use of the social media associated with the device

    Time frame: Two years (6 Month Time Point)

    Qualitative data obtained by open-ended interview

  12. PHQ9

    Time frame: 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.

  13. GAD-7

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Pilot RCT Study Using a Fitbit Device to Improve Exercise Tolerance in 80 Patients With Cystic Fibrosis

Acronym: INTERACT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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