Phase 2
N=21
Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT05239611 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result — -6.67; -7.63 change shuttles (1 shuttle is 10 meters)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Xenon MRI (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result |
-6.67; -7.63 | — |
| PRIMARY Ventilation Defect Percentage (VDP) as Detected by 129Xenon MRI |
20.7; 24.2 | — |
| SECONDARY Forced Expiratory Volume in 1 Second |
1.2; -0.38 | — |
| SECONDARY Quality of Life Assessment. |
-2.0; -4.91 | — |
| SECONDARY Exercise Time |
1290 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- pregnancy
- history of solid organ transplant
- active treatment for mycobacterial infections
- significant untreated hypoxemia, oxygen dependent at rest or with exercise
- FEV1 140 mm Hg, diastolic blood pressure > 90 mmHg)
- 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
Data sourced from ClinicalTrials.gov (NCT05239611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.