NCT04680403

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

December 17, 2020

Last Update Submit

January 29, 2026

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability

    Feasibility and acceptability will include patients willingness to participate

    6 months

Study Arms (1)

supervised exercise plan

EXPERIMENTAL

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

Interventions

ExerciseOTHER

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.

Also known as: Behavior Change Coaching
supervised exercise plan

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • any comorbidity that precludes exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stefanie Krick

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 23, 2020

Study Start

July 1, 2022

Primary Completion

January 1, 2025

Study Completion

December 31, 2025

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)