Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial (INTERACT)

• ClinicalTrials.gov Identifier: NCT02700243
• Recruitment Status: Unknown
• First Posted: March 7, 2016
• Last Update Posted: July 24, 2018
• Sponsor: Boston Children's Hospital
• Information provided by (Responsible Party): Ahmet Uluer, Boston Children's Hospital

Tracking Information

• First Submitted Date: February 21, 2016
• First Posted Date: March 7, 2016
• Last Update Posted Date: July 24, 2018
• Actual Study Start Date: March 14, 2016
• Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 1, 2016)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 1, 2016)

• 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 ]
  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.
• 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.
• 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.
• 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) ]
  Qualitative data obtained by open-ended interview
• 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
• 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
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial
• Official Title: Pilot RCT Study Using a Fitbit Device to Improve Exercise Tolerance in 80 Patients With Cystic Fibrosis
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cystic Fibrosis

Intervention

Behavioral: Fitbit

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

Study Arms

• Experimental: Fitbit
  Participants receive a Fitbit and are followed over the course of one year, completing surveys and exercise tests.
  Intervention: Behavioral: Fitbit
• No Intervention: Usual Care
  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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: April 5, 2017): 40
• Original Estimated Enrollment (submitted: March 1, 2016): 80
• Estimated Study Completion Date: April 2019
• Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02700243
• Other Study ID Numbers: IRB-P00012871
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.

• Responsible Party: Ahmet Uluer, Boston Children's Hospital
• Study Sponsor: Boston Children's Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ahmet Uluer, DO; Boston Children's Hospital

• PRS Account: Boston Children's Hospital
• Verification Date: July 2018