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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

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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