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Table 1 Overview of measurements per visit

From: Multifactorial intervention for children with asthma and overweight (Mikado): study design of a randomised controlled trial

 

Baseline

T3

T6

T9

T12

T15

T18

Lung function parameters

       

MEFV curves: FEV1, FVC, FEV1/FVC, PEF, MEF50 (absolute and %predicted values)*

X

 

X

 

X

 

X

Static lung function test: TLC, RV, FRC, ERV

X

     

X

BHR

X

      

Maximum Ergometry test: VO2max, HRmax, %fall in FEV1

X

     

X

Inflammatory parameters

       

FeNO

X

     

X

EBC: pH, IL-1α, 2, -4, -5, -10, -13, TNF-α, sICAM-1

X

     

X

Serum: leptin

X

     

X

Questionnaires

       

PAQLQ verbal questionnaire for 6–11 year, written questionnaire for 12–16 year

X

 

X

 

X

 

X

EQ-5D-Youth questionnaire

X

X

X

X

X

X

X

c-ACT questionnaire for 6–11 year, ACT questionnaire for 12–16 year

X

 

X

 

X

 

X

ISAAC questionnaire + additional questions about symptoms and exacerbations. Parental version for 6–11 year, self-administered version for 12–16 year

X

 

X

 

X

 

X

GERD questionnaire. Parental version for 6–11 year, self-administered version for 12–16 year

X

X

X

X

X

X

X

PSQ questionnaire. Parental version for 6–11 year, self-administered version for 12–16 year

X

 

X

 

X

 

X

c-DEBQ questionnaire version for 6–11 year, DEBQ for 12–16 year

X

     

X

SDQ questionnaire. Parental version for 6–11 year, parental and self-administered version for 12–16 year

    

X

  

Demographic factors: e.g. smoking, pets, parental educational level and BMI

X

     

X

Medication use

X

X

X

X

X

X

X

Health care utilization

X

X

X

X

X

X

X

Anthropometric values

       

Weight

X

Xi

X

Xi

X

Xi

X

Length

X

Xi

X

Xi

X

Xi

X

Waist and hip circumference

X

 

X

 

X

 

X

4-fold Skinfold measurement

X

 

X

 

X

 

X

Intervention outcome measures

       

3 × 24 hour food record

X

Xi

X

 

X

 

X

7 days accelerometer output

X

Xi

X

 

X

 

X

Continuously measured parameters

Percentage presence during the sport sessions, lifestyle sessions, parental sessions and individual counselling sessions. Average heart beat during the sport sessions, BORG score of fatigue [59] after the sport sessions, motivation of the participants (1–10) rated by the sport instructor after the sport sessions, amount of asthma attacks during sporting and safety of the participants.

  1. Legend: * Pre- and post-bronchodilator spirometry will be obtained during every visit to determine reversibility. At baseline, reversibility will be determined after the BHR test. Xi = Data only obtained in the intervention group.
  2. Abbreviations: ACT, Asthma control test; BHR, Bronchial hyper-responsiveness; BMI, Body mass index; BORG, Perceived exertion and pain scale; c-ACT, Childhood asthma control test; c-DEBQ, Childhood dutch eating behavioural questionnaire; DEBQ, Dutch eating behavioural questionnaire; ERV, Expiratory reserve volume; EQ-5D-Youth, Youth version of Euroqol 5D quality of life questionnaire; FEV 1 , Forced expiratory volume in 1 second; FRC, Functional residual capacity; FVC, Forced vital capacity; GERD, Gastro oesophageal reflux disease; HRmax, Maximum heart rate; IL, Interleukin; ISAAC, International study of asthma and allergy in childhood; MEF 50 , Maximum expiratory flow rate at 50% of vital capacity; PAQLQ, Paediatric asthma quality of life questionnaire; PEF, Peak expiratory flow, pH, Acidity; PSQ, Paediatric sleep questionnaire; RV, Residual volume; SDQ, Strengths and difficulties questionnaire; sICAM-1, Soluble intercellular adhesion molecule-1; TLC, Total lung capacity; TNF-α, Tumour necrosis factor-alpha; VO 2max , Maximal oxygen uptake.
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BMC Public Health

ISSN: 1471-2458

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