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Table 2 Details of the primary outcome measures and the measurement tools used.

From: Design of the Quality of Life in Motion (QLIM) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical exercise and psychosocial training program to improve physical fitness in children with cancer

Primary outcome measures

Measurements

Cardiorespiratory fitness

Lode Corival bicycle ergometry with paediatric options; LODE BV, Groningen, the Netherlands.

Steep Ramp Test [35]

VO2 peak performance test

Muscle strength

CITEC hand-held dynamometer; C.I.T. Technics BV, Haren, the Netherlands

Secondary outcome measures

Measurements

Fatigue

PedsQL Multidimensional Fatigue Scale Acute Version (self-report and parent-proxy report) [30]

Body composition

Dual Energy X-ray Absorptiometry (DEXA) scan (Hologic QDR 4500); Hologic Bedford, USA.

Body Mass Index

Blood: calcium, phosphate, magnesium, carboxy-terminal collagen crosslinks (CTX), parathyroid hormone (PTH), serum amino-terminal procollagen 1 extension peptide (P1NP), insulin-like growth factors 1 (IGF-1), 25-hydroxy-vitamin D (25 OH vit D)

Daily physical activity levels

Physical activity accelerometer: Actical 2.1; Respironics, Mini Mitter, Oregon USA

Depression

Children's Depression Inventory (CDI) [32]

Quality of life

PedsQL 4.0 Generic Score Scale (self-report and parent-proxy report) [30]

PedsQL 3.0 Cancer Module (self-report and parent-proxy report) [30]

Self-perception

Self-Perception Profile for Children (CBSK) [31]

Self-Perception Profile for Adolescents (CBSA) [33]

Behavioural problems

Child Behavior Checklist (CBCL) [34]

Youth Self-Report (YSR) [34]

Cost data

Monthly cost diary

Other study outcomes

Measurements

Compliance

Self-report Attendance checklist for training sessions

Satisfaction with the intervention

Questionnaire 11-items

Clinical data

Medical record

Moderating variables

Questionnaire addressing pre-illness lifestyle, current attitudes towards and beliefs about exercise, physical activity patterns.