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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700243
Recruitment Status : Unknown
Verified July 2018 by Ahmet Uluer, Boston Children's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmet Uluer, Boston Children's Hospital

Tracking Information
First Submitted Date  ICMJE February 21, 2016
First Posted Date  ICMJE March 7, 2016
Last Update Posted Date July 24, 2018
Actual Study Start Date  ICMJE March 14, 2016
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Behavioral: Fitbit
Participants receive a Fitbit and are followed over the course of one year to determine use and health outcomes.
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2016)
80
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02700243
Other Study ID Numbers  ICMJE IRB-P00012871
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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  ICMJE Boston Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmet Uluer, DO Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP