Background
Methods
Study design
Study population
Randomisation
Withdrawal from study
Physical activity intervention
Intervention arm
Control arm
Recruitment and study procedures
Baseline | 3 month | 6 month | 9 month | 12 month | ||
Visit | 1a | 1b | 2 | 3 | 4 | 5 |
Time | −21 d (±7 d) | Day 1 | 90 d (±14 d)a | 180 d (±14 d)a | 270 d (±14 d)a | 360 d (±14 d)a |
Informed consent | X | |||||
Medical history | X | |||||
In−/exclusion criteria | X | X | ||||
Physical examination, vital signs | X | X | X | X | X | X |
Physical (in)activity history | X | |||||
Anthropometry | X | X | X | X | X | X |
Spirometry | X | X | X | X | X | X |
Body plethysmography | X | X | X | X | X | X |
Oral glucose tolerance test | X | X | ||||
Cardiopulmonary exercise testing | X | X | X | |||
Pedometry | X | (X)b | X | (X)b | X | |
Physical activity questionnaire (7-day recall) | X | X | X | X | X | X |
Exacerbations, upper respiratory tract infections, antibiotic use, adverse events | X | X | X | X | X | X |
CFQ-R questionnaire | X | X | X | |||
DASS questionnaire | X | X | X | |||
EMI 2 questionnaire | X | X | X | |||
Diary, 3-months retrospective questionnaire, Interviewc, Patient-initiated contact | X | X | X | X | X | X |
For Intervention group only | ||||||
Exercise motivation interviewc | X | X | X | X | X | X |
Web-based diary, paper diary, pedometerd | XXXXXX | |||||
Schedule of measurements for the sub-studies in selected centers | ||||||
Baseline | 3 month | 6 month | 9 month | 12 month | ||
Visit | 1a | 1b | 2 | 3 | 4 | 5 |
Time | −21 d (±7 d) | Day 1 | 90 d (±14 d) | 180 d (±14 d) | 270 d (±14 d) | 360 d (±14 d) |
Accelerometrye | X | X | X | |||
Multiple breath washoute | X | X | X | X | ||
DXAe | X | X | X | |||
Scintigraphye | X | X |
Study endpoints and measurements
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 |