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

NCT05239611 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00146919
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• Cardiorespiratory Fitness Assessment- Modified Shuttle Walk Test Result

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

  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

  3 months

Secondary Outcomes (3)

• Forced Expiratory Volume in 1 Second

  3 months

• Quality of Life Assessment.

  3 months

• Exercise Time

  3 months

Study Arms (2)

Xenon MRI only, without exerercise intervention

OTHER

Participants will receive usual standard of care and undergo a xenon MRI.

Diagnostic Test: Xenon MRI

Xenon MRI with exercise coaching

ACTIVE COMPARATOR

Participants will receive weekly coaching intervention and undergo a xenon MRI

Diagnostic Test: Xenon MRI

Interventions

Xenon MRI DIAGNOSTIC_TEST

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.

Also known as: exercise

Xenon MRI only, without exerercise intervention; Xenon MRI with exercise coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Joel Mermis
• Organization: University of Kansas Medical Center

jmermis@kumc.edu

913-588-6045

Study Officials

• Dave Burnett, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 15, 2022
• Study Start: March 15, 2022
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: at completion of study analysis. no planned end date
• Access Criteria: upon request to primary investigator

Locations

US (1)