Status:
COMPLETED
Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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) ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05239611
Start Date
March 15 2022
End Date
August 3 2023
Last Update
June 12 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160