Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial

NCT02700243 | Completed

• 1 other identifier: IRB-P00012871
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Exercise; Fitbit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Fitbit activity data

  Two years

• HAES (Habitual Activity Estimation Scale)

  Two years

• Relative change from baseline in ppFEV1

  Two years

• Relative change from baseline in ppFVC

  Two years

• Relative change from baseline in ppFEF25-75

  Two years

Study Arms (2)

Fitbit

EXPERIMENTAL

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

Behavioral: Fitbit

Usual Care

NO INTERVENTION

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.

Interventions

Fitbit BEHAVIORAL

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

Fitbit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• Ahmet Uluer, DO

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Adult Cystic Fibrosis Program

Study Record Dates

• First Submitted: February 21, 2016
• First Posted: March 7, 2016
• Study Start: March 14, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share