NCT05239611

Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis

Completed Phase 2 Results posted Last updated 12 June 2025

What this trial tests

Phase 2 trial testing Xenon MRI in Cystic Fibrosis in 21 participants. Completed in 3 August 2023.

Timeline

15 March 2022

Primary endpoint
3 August 2023

3 August 2023

Quick facts

Lead sponsor	University of Kansas Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	15 March 2022
Primary completion	3 August 2023
Estimated completion	3 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Xenon MRI — full drug profile →

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University of Kansas Medical Center

Who can join

18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result Primary · 3 months

change in number of modified shuttles completed between baseline/enrollment and study completion at 3 months

Group	Value	95% CI
Xenon MRI Only, Without Exerercise Intervention	-6.67	± 9.33
Xenon MRI With Exercise Coaching	-7.63	± 9.84

Ventilation Defect Percentage (VDP) as Detected by 129Xenon MRI Primary · 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

Group	Value	95% CI
Xenon MRI Only, Without Exerercise Intervention	20.7	± 9.0
Xenon MRI With Exercise Coaching	24.2	± 12.6

Forced Expiratory Volume in 1 Second Secondary · 3 months

lung function will be assessed at baseline/enrollment and study completion at 3 months

Group	Value	95% CI
Xenon MRI Only, Without Exerercise Intervention	1.2	± 4.66
Xenon MRI With Exercise Coaching	-0.38	± 3.42

Quality of Life Assessment. Secondary · 3 months

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)

Group	Value	95% CI
Xenon MRI Only, Without Exerercise Intervention	-2.0	± 10.82
Xenon MRI With Exercise Coaching	-4.91	± 7.06

Exercise Time Secondary · 3 months

assess weekly adherence to prescribed exercise time completed

Group	Value	95% CI
Xenon MRI With Exercise Coaching	1290	285 – 2500

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Physical activity and exercise training in cystic fibrosis.
   Radtke T, Smith S, Nevitt SJ, Hebestreit H, et al · · 2022 · cited 31× · PMID 35943025 · DOI 10.1002/14651858.cd002768.pub5
2. Interventions for improving adherence to airway clearance treatment and exercise in people with cystic fibrosis.
   Jones M, Moffatt F, Harvey A, Ryan JM. · · 2023 · cited 5× · PMID 37462324 · DOI 10.1002/14651858.cd013610.pub2