Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial

NCT ID: NCT02700243

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-14
• Study Completion Date: 2019-04-30

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fitbit

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

Group Type: EXPERIMENTAL

Fitbit

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fitbit

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Uluer

Director, Adult Cystic Fibrosis Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet Uluer, DO

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Other Identifiers

IRB-P00012871

Identifier Type: -

Identifier Source: org_study_id