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Table 2 Primary, secondary and explorative outcome measures

From: Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol

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
  1. CFQ-R Cystic Fibrosis Questionnaire-revised, CPET cardiopulmonary exercise test, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, RV/TLC residual volume/total lung capacity, VO 2peak peak oxygen uptake, Watt max maximal aerobic power
  2. aonly in patients without cystic fibrosis related diabetes
  3. bonly in European centers
  4. cselected centers only
  5. dUS centers only