Back to results

Video Telehealth Exercise Training in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional prevention trial for Cystic Fibrosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

supervised exercise plan

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility and acceptability

Feasibility and acceptability will include patients willingness to participate

Secondary Outcome Measures

Full Information

NCT ID

NCT04680403

First Posted

December 17, 2020

Last Updated

January 23, 2023

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT04680403

Brief Title

Video Telehealth Exercise Training in Cystic Fibrosis

Official Title

Video Telehealth Exercise Training in Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

supervised exercise plan

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Exercise

Other Intervention Name(s)

Behavior Change Coaching

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility and acceptability

Description

Feasibility and acceptability will include patients willingness to participate

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heather Hathorne

Phone

205-638-9568

hhathorne@peds.uab.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefanie Krick

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heather Hathorne

Phone

205-638-9568

hhahtorne@peds.uab.edu

First Name & Middle Initial & Last Name & Degree

Stefanie Krick, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Video Telehealth Exercise Training in Cystic Fibrosis

We'll reach out to this number within 24 hrs