Table 2 Primary, secondary and explorative outcome measures
Outcome | Variable | Measurement |
|---|---|---|
Primary endpoint | ||
 • Lung function | FEV1% predicted | Spirometry |
Secondary endpoints | ||
 • Exercise capacity | VO2peak % predicted | CPET |
Wattmax % predicted | CPET | |
 • Physical activity | Steps per day | Pedometry |
Exercise steps per day | Pedometry | |
Reported physical activity (min per day) | 7-day recall questionnaire | |
 • Pulmonary function | FEV1% predicted | Spirometry, Bodyplethysmography |
FVC % predicted | ||
RV/TLC % | ||
 • Exacerbation | Time to first exacerbation | Questionnaire (modified Fuchs criteria) and physician assessment |
 • Body composition | Body fat | Skinfolds |
Lean body mass | Skinfolds | |
 • Health-related quality of life | Scales | Questionnaire (CFQ-R) |
 • Depression, anxiety and stress scales | Scales | Questionnaire (DASS) |
 • Glycaemic control | Plasma glucose concentrations (fasting, 1 and 2 h after standardised glucose load) | Oral glucose tolerance testa |
Explorative endpoints | ||
 • Physical activity | Moderate and vigorous physical activity | Accelerometryb |
 • Infections | Number of upper respiratory tract infections | 3-months retrospective questionnaire, Interviews, Diary and telephone calls |
 • Antibiotic therapy | Days on additional oral/intravenous antibiotics | 3-months retrospective questionnaire, Interviews, Diary and telephone calls |
 • Body composition | Body mass index | Based on measured height and weight |
 • Lung function | Lung clearance index | Multiple breath washoutc |
 • Mucociliary clearance | Mucociliary clearance | Scintigraphyd |
Safety endpoints | ||
 • Adverse events | Adverse events at least possibly related to exercise (e.g., sprains, fractures etc) | Judged by investigator |
Others | ||
 • Compliance with exercise | Exercise goal of 3 additional hours of vigorous activity per week | Baseline assessment and web-based diary |