Cystic FibrosisNCT04680403
Video Telehealth Exercise Training in Cystic Fibrosis
A study testing Exercise in people with Cystic Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this research study is to begin an exercise program for patients with a cystic fibrosis (CF) exacerbation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Cystic Fibrosis 18 years old and older clinically stable with no exacerbation within 6 weeks
Who cannot join
- any comorbidity that precludes exercise
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
The purpose of this research study is to begin an exercise program for patients with a cystic fibrosis (CF) exacerbation.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Exercise
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Behavior Change Coaching
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability
Feasibility and acceptability will include patients willingness to participate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Jul 2022
- Primary completion1 Jan 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanie Krick MD, University of Alabama at Birmingham
- Investigators
- Stefanie Krick, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680403
- Sponsor's protocol ID
- IRB-300006495
- Other IDs
- Vertex Innovation Award
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saag J, Bergeron J, Bailey J, Monroe K, Hathorne H, Solomon GM, Lowman JD, Bhatt SP, Garcia B, Krick S. Pilot and Feasibility Study of an Individualized Telehealth Exercise Program for People with Cystic Fibrosis. J Funct Morphol Kinesiol. 2026 Mar 26;11(2):136. doi: 10.3390/jfmk11020136.
PubMed 42029504
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Telehealth Exercise Training in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04680403
- Acronym / sponsor ID
- IRB-300006495
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| supervised exercise plan | Experimental | Other: Exercisepatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with Cystic Fibrosis 18 years old and older clinically stable with no exacerbation within 6 weeks
Key exclusion criteria (2 listed)
- any comorbidity that precludes exercise
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Behavior Change Coachingsupervised 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 | supervised exercise plan |
Primary outcome
Feasibility and acceptability
Time frame: 6 months
Feasibility and acceptability will include patients willingness to participate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Derived from this study: PubMed 42029504Saag J, Bergeron J, Bailey J, Monroe K, Hathorne H, Solomon GM, Lowman JD, Bhatt SP, Garcia B, Krick S. Pilot and Feasibility Study of an Individualized Telehealth Exercise Program for People with Cystic Fibrosis. J Funct Morphol Kinesiol. 2026 Mar 26;11(2):136. doi: 10.3390/jfmk11020136.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanie Krick principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cystic Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04680403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.