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Table 1 Data collected at baseline and follow-up

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

  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   
  1. CFQ-R Cystic Fibrosis Questionnaire-revised, DASS Depression and Anxiety Stress Scales, DXA Dual energy X-ray absorptiometry, EMI Exercise Motivational Inventory
  2. aIn case of an exacerbation the visit will be postponed until 14 days after oral or intravenous antibiotic treatment of exacerbation has been stopped
  3. bIntervention group only
  4. cAt each visit and at scheduled telephone contacts
  5. dOver the whole intervention period of 12 months
  6. eIn selected centres only