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NCT04680403 Clinical Trial

Video Telehealth Exercise Training in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:
Video Telehealth Exercise Training in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04680403
Other study ID # IRB-300006495
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 2025

Study information
Verified date January 2024
Source University of Alabama at Birmingham
Contact Heather Hathorne
Phone 205-638-9568
Email hhathorne@peds.uab.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to begin an exercise program for patients with a cystic fibrosis (CF) exacerbation.

Description:

The study will enroll 25 patients with CF during an introduction visit and initiate an ambulatory 1) tailored exercise regimen and 2) behavior change techniques focused on adherence and sustainability of exercise. The intervention will be delivered via a data-enabled smartphone with video capabilities facilitating live and interactive two-way video-conferencing using a HIPAA compliant app. Participants will receive supervised exercise paired with coaching on behavior change techniques over 12 weeks in 3 weekly 1-hour sessions, and will have monthly phone follow-ups and clinic follow-ups at 3 and 6 months.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date December 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: Diagnosed with Cystic Fibrosis 18 years old and older clinically stable with no exacerbation within 6 weeks Exclusion Criteria: any comorbidity that precludes exercise -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Exercise
supervised exercise paired with coaching on behavior change techniques over 12 weeks (3 weekly sessions) and will have monthly phone follow-ups and clinic follow-ups after 3 and 6 months.

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility and acceptability Feasibility and acceptability will include patients willingness to participate 6 months
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