Cystic FibrosisPhase 2NCT05239611
Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis
A Phase 2 study testing Xenon MRI in people with Cystic Fibrosis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The main objective of this clinical pilot study is to evaluate the feasibility and impact of a home-based exercise program on clinical and patient-centered outcomes in adult with cystic fibrosis (CF) and inform the design of a larger clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Xenon MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 3 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cystic fibrosis patients 18 years of age and older, confirmed diagnosis of CF (two CF mutations or sweat chloride > 60 mmol/L)
- stable while either on/off Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator therapy and no plan to start/discontinue CFTR modulator therapy
- clearance from their CF physician to participate in exercise
- have access to the internet
- not involved in an exercise intervention in the previous 6 months, and not performing structured exercise > 150 minutes per week.
Who cannot join
- pregnancy
- history of solid organ transplant
- active treatment for mycobacterial infections
- significant untreated hypoxemia, oxygen dependent at rest or with exercise
- FEV1 < 40% of predicted or clinical evidence of cor pulmonale
- untreated arterial hypertension (resting systolic blood pressure >140 mm Hg, diastolic blood pressure > 90 mmHg)
Show all 13Show fewer
- systolic blood pressure less than 90 mm Hg while standing
- congestive heart failure
- active treatment for Allergic Bronchopulmonary Aspergillosis (ABPA)
- acute upper or lower respiratory infection or pulmonary exacerbation within 4 weeks prior to Day 1
- changes in therapy (including antibiotics) for pulmonary disease within 4 weeks prior to Day 1
- significant hemoptysis within 4 weeks prior to Day 1 (≥ 5 mL of blood in one coughing episode or > 30 mL of blood in a 24 hour period
- ongoing participation in an investigational drug study within 60 days prior to Day 1
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis to Improve Patient-centered Outcomes, Including a Novel Measure of Ventilation
The main objective of this clinical pilot study is to evaluate the feasibility and impact of a home-based exercise program on clinical and patient-centered outcomes in adult with cystic fibrosis (CF) and inform the design of a larger clinical trial.
Read the detailed description
This pilot and feasibility study is a randomized controlled trial comparing exercise intervention with a usual care group. Participants will be randomized based on a randomization table developed by a biostatistician who is not involved in the study. The exercise intervention group will be delivered with a telehealth platform using internet (Zoom HIPAA-Compliant video), an app, phone, and email/text support. Participants will be randomly allocated to either an exercise coaching program or a usual care arm. The exercise intervention arm will follow guidelines established by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and complement best clinical practices established by the American Thoracic Society/European Respiratory Society (ATS/ERS). The usual care arm will be provided a handout on resources for engaging in physical activity.
Aim 1. Examine the feasibility of a home-based Tele-rehab intervention. Indicators of feasibility will include recruitment and adherence. Hypothesis 1: Based on previous trials, the investigators predict that >50% of eligible participants will consent to the study. Hypothesis 2: Again, based on previous trials, >70% of participants in the intervention arm will adhere to >70% of their weekly prescribed exercise. Also, the investigators will assess reasons for; 1) eligible patients who don't enroll, 2) participants' non-adherence, and 3) non-completers.
Aim 2. Evaluate the impact of a home-based exercise program in adults with CF for improving clinical and patient-centered outcomes. Hypothesis 1: There will be a greater improvement in exercise capacity (measured by a modified shuttle test), a novel measure of lung function 129Xenon MRI (129Xe MRI), forced expiratory volume in 1 second (FEV1), and quality of life with participants in the intervention arm when compared to usual care. Hypothesis 2: Changes in exercise capacity and 129Xe MRI will be associated with exercise adherence, as noted in Aim 1.
- Conditions
- Cystic Fibrosis
- Being tested
- Xenon MRI
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon MRIDiagnostic test
Also called exercise
Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention.
| Study group | Role | What they receive |
|---|---|---|
| Xenon MRI only, without exerercise intervention | Other | Participants will receive usual standard of care and undergo a xenon MRI. Receives: Diagnostic Test: Xenon MRI |
| Xenon MRI with exercise coaching | Active comparator | Participants will receive weekly coaching intervention and undergo a xenon MRI Receives: Diagnostic Test: Xenon MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result
change in number of modified shuttles completed between baseline/enrollment and study completion at 3 months
Measured: 3 months
Ventilation Defect Percentage (VDP) as Detected by 129Xenon MRI
Hyperpolarized 129Xe ventilation MRI will be performed to assess VDP at baseline (within 2 weeks of initiation of study) and after completion of the intervention/usual care-control period
Measured: 3 months
Secondary outcomes (3)
Forced Expiratory Volume in 1 Second
lung function will be assessed at baseline/enrollment and study completion at 3 months
Measured: 3 months
Quality of Life Assessment.
Cystic Fibrosis questionnaire-revised (CFQR) will be assessed at baseline/enrollment and study completion at 3 months. Scale 0-100 (high score indicates better quality of life)
Measured: 3 months
Exercise Time
assess weekly adherence to prescribed exercise time completed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 Mar 2022
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Kansas Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dave Burnett, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239611
- Sponsor's protocol ID
- STUDY00146919
- Status last verified
- Jun 2025
- First submitted
- 10 Jan 2022
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pilot participant data available upon request by other researchers
Publications
Barry A, Niedbalski P, Bustos A, Burnett D, He J, Mermis J. Feasibility and Impact of a Coached Home-Based Exercise Program on Cardiorespiratory Fitness in Adults With Cystic Fibrosis on Highly Effective Modulator Therapy. CHEST Pulm. 2026 Mar 9;4(3):100252. doi: 10.1016/j.chpulm.2026.100252. eCollection 2026 Sep.
PubMed 42729704
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis to Improve Patient-centered Outcomes, Including a Novel Measure of Ventilation
- ClinicalTrials.gov ID
- NCT05239611
- Acronym / sponsor ID
- STUDY00146919
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this clinical pilot study is to evaluate the feasibility and impact of a home-based exercise program on clinical and patient-centered outcomes in adult with cystic fibrosis (CF) and inform the design of a larger clinical trial.
Detailed description
This pilot and feasibility study is a randomized controlled trial comparing exercise intervention with a usual care group. Participants will be randomized based on a randomization table developed by a biostatistician who is not involved in the study. The exercise intervention group will be delivered with a telehealth platform using internet (Zoom HIPAA-Compliant video), an app, phone, and email/text support. Participants will be randomly allocated to either an exercise coaching program or a usual care arm. The exercise intervention arm will follow guidelines established by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and complement best clinical practices established by the American Thoracic Society/European Respiratory Society (ATS/ERS). The usual care arm will be provided a handout on resources for engaging in physical activity.
Aim 1. Examine the feasibility of a home-based Tele-rehab intervention. Indicators of feasibility will include recruitment and adherence. Hypothesis 1: Based on previous trials, the investigators predict that >50% of eligible participants will consent to the study. Hypothesis 2: Again, based on previous trials, >70% of participants in the intervention arm will adhere to >70% of their weekly prescribed exercise. Also, the investigators will assess reasons for; 1) eligible patients who don't enroll, 2) participants' non-adherence, and 3) non-completers.
Aim 2. Evaluate the impact of a home-based exercise program in adults with CF for improving clinical and patient-centered outcomes. Hypothesis 1: There will be a greater improvement in exercise capacity (measured by a modified shuttle test), a novel measure of lung function 129Xenon MRI (129Xe MRI), forced expiratory volume in 1 second (FEV1), and quality of life with participants in the intervention arm when compared to usual care. Hypothesis 2: Changes in exercise capacity and 129Xe MRI will be associated with exercise adherence, as noted in Aim 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenon MRI only, without exerercise intervention | Other | Diagnostic Test: Xenon MRIParticipants will receive usual standard of care and undergo a xenon MRI. |
| Xenon MRI with exercise coaching | Active comparator | Diagnostic Test: Xenon MRIParticipants will receive weekly coaching intervention and undergo a xenon MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- cystic fibrosis patients 18 years of age and older, confirmed diagnosis of CF (two CF mutations or sweat chloride > 60 mmol/L)
- stable while either on/off Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator therapy and no plan to start/discontinue CFTR modulator therapy
- clearance from their CF physician to participate in exercise
- have access to the internet
- not involved in an exercise intervention in the previous 6 months, and not performing structured exercise > 150 minutes per week.
Key exclusion criteria (13 listed)
- pregnancy
- history of solid organ transplant
- active treatment for mycobacterial infections
- significant untreated hypoxemia, oxygen dependent at rest or with exercise
- FEV1 < 40% of predicted or clinical evidence of cor pulmonale
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 |
|---|---|---|
| Xenon MRIAlso: exerciseStudy participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention. | Diagnostic test | Xenon MRI only, without exerercise intervention, Xenon MRI with exercise coaching |
Primary outcome
Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result
Time frame: 3 months
change in number of modified shuttles completed between baseline/enrollment and study completion at 3 months
Ventilation Defect Percentage (VDP) as Detected by 129Xenon MRI
Time frame: 3 months
Hyperpolarized 129Xe ventilation MRI will be performed to assess VDP at baseline (within 2 weeks of initiation of study) and after completion of the intervention/usual care-control period
3 secondary outcomes
Forced Expiratory Volume in 1 Second
Time frame: 3 months
Quality of Life Assessment.
Time frame: 3 months
Exercise Time
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42729704Barry A, Niedbalski P, Bustos A, Burnett D, He J, Mermis J. Feasibility and Impact of a Coached Home-Based Exercise Program on Cardiorespiratory Fitness in Adults With Cystic Fibrosis on Highly Effective Modulator Therapy. CHEST Pulm. 2026 Mar 9;4(3):100252. doi: 10.1016/j.chpulm.2026.100252. eCollection 2026 Sep.
- Individual participant dataSharing planned: Yes. Pilot participant data available upon request by other researchers
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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.
Dave Burnett, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xenon MRI in people with Cystic Fibrosis, run by University of Kansas Medical Center 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 5 inclusion and 13 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 12 Jun 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05239611, 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 12 Jun 2025.