Video Telehealth Exercise Training in Cystic Fibrosis

Not Applicable

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Other: Exercise

• Registration Number: NCT04680403
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-23
• Study Start: 2022-07-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Diagnosed with Cystic Fibrosis 18 years old and older clinically stable with no exacerbation within 6 weeks

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Exclusion Criteria

any comorbidity that precludes exercise

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
supervised exercise plan	Exercise	patients will receive a tailored exercise regimen and behavior change techniques focused on adherence to the exercise program. These will be delivered by using a video platform, much liker telehealth clinic appointments. These telehealth visits will be over a 12-week period, occur 3 times a week, and last for 1 hour each.

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability	6 months	Feasibility and acceptability will include patients willingness to participate

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States