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

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center

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 < 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