Video Telehealth Exercise Training in Cystic Fibrosis

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04680403
Collaborator
(none)
25
1
1
30
0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Video Telehealth Exercise Training in Cystic Fibrosis
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: supervised exercise plan

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.

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.
Other Names:
  • Behavior Change Coaching
  • Outcome Measures

    Primary Outcome Measures

    1. Feasibility and acceptability [6 months]

      Feasibility and acceptability will include patients willingness to participate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: Stefanie Krick, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefanie Krick MD, MD, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT04680403
    Other Study ID Numbers:
    • IRB-300006495
    First Posted:
    Dec 23, 2020
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2022