Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial

Cystic Fibrosis Clinical Trial

— INTERACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700243
• Other study ID #: IRB-P00012871
• Status: Completed
• Phase: N/A
• Start date: March 14, 2016
• Est. completion date: April 2019

Study information

• Verified date: June 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graded exercise test (Submaximal GXT)	Change is submaximal GXT will be assessed for all participants	Two years (Enrollment, 6 months, 12 months, 24 months)
Secondary	Fitbit activity data		Two years
Secondary	HAES (Habitual Activity Estimation Scale)		Two years
Secondary	Relative change from baseline in ppFEV1	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
Secondary	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
Secondary	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
Secondary	Incidence of exacerbations requiring IV antibiotics		Two years
Secondary	BMI		Two years
Secondary	CFQ-R (Survey on Quality of Life in Cystic Fibrosis)		Two years
Secondary	Overall qualitative assessment of participant satisfaction with the Fitbit	Qualitative data obtained by open-ended interview	Two years (6 Month Time Point)
Secondary	Overall qualitative assessment of participant's potential barriers to Fitbit use	Qualitative data obtained by open-ended interview	Two years (6 Month Time Point)
Secondary	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)
Secondary	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)
Secondary	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)