Physical activity, physical fitness, muscle strength, fatigue, obesity, bone mineral density, mood, health-related quality of life, chemotherapy, radiotherapy, childhood cancer. Lichamelijke activiteit, uithoudingsvermogen, kracht, vermoeidheid, botdichtheid, overgewicht, kwaliteit van leven, kinderkanker, chemotherapie, radiotherapie
Conditions
Interventions
The QLIM intervention consists of a combined physical exercise (a) and psychosocial support (b) training program followed by a 1 day booster session (c).
A) The FITstrong physical training program
Sponsors
VU university medical center
Wilhelmina Children's Hospital, UMC Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: Children who are: 1. 8-18 years at the time of intervention 2. Diagnosed with any type of childhood malignancy 3. Treated with chemo-and or radiotherapy 4. No longer than 12 months off treatment
Exclusion criteria
Exclusion criteria: Children who: 1. Require a bone marrow transplantation 2. Require growth hormone treatment 3. Depend on a wheelchair 4. Are unable to “ride a bike” 5. Are not able to read, or write 6. Are not able to self-reflect, and/or follow instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Cardiorespiratory fitness 2) Muscle strength Ad 1) Cardiorespiratory fitness will be assessed by the peak oxygen consumption (VO2-peak), peak work load (Wmax) and peak heart rate from a graded exercise test on an electronically braked cycle ergometer. After 1 minute of cycling without resistance, the workload is increased by 10, 15 or 20 Watts every minute according to the Godfrey protocol. The highest achieved workload (Wmax) will be recorded. The patients will breathe through a facemask connected to a calibrated metabolic cart. Breath-by-breath minute ventilation, oxygen consumption, carbon dioxide production, and the respiratory exchange ratio will be calculated from conventional equations. Heart rate will be measured continuously during the aerobic exercise test by a bipolar electrocardiogram or heart rate monitor. VO2-peak will be calculated as the average value over the last 20 sec before subjective exhaustion. Prior to the aerobic exercise test pulmonary function will be assessed at rest by measuring the forced air expiratory volume in 1 second and the forced vital capacity using a portable spirometer. The best out of 3 forced expiratory flow-volumes (in upright position) will be recorded. In addition, systolic and diastolic blood pressure will be measured in upright sitting position using an automatic device. Ad 2) Muscle strength of the proximal and distal muscles in the upper and lower extremities will be measured by a calibrated hand-held dynamometer both at the right and left side of the body. Three consecutive measurements will be performed using the ‘break method’. The highest value will be registered. In the upper extremity, grip strength and strength of the shoulder abductors and the wrist extensors will be measured. In the lower extremity the muscular strength of the hip flexors and the knee and dorsal foot extensors will be measured. All within subject tests will be performed by the same assessor using the same hand held dynamometer to preven | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatigue 2. Body composition 3. Daily physical activity levels 4. Depression 5. Health-related quality of life 6. Self-perception 7. Behavioral problems Ad1) Fatigue will be assessed by the 18-item PedsQL Multidimensional Fatigue Scale Acute Version. This instrument is a module of the PedsQL 4.0 Generic Core Scale. The module encompasses 3 subscales: 1) general fatigue (6 items), sleep/rest fatigue (6 items), and cognitive fatigue (6 items). Ad 2) Body composition (fat mass, muscle mass, bone mineral density (total and at the lumbar spine)) will be assessed by whole body dual energy X-ray (DEXA) scanning. In addition, body mass index (kg/m2) will be determined by dividing weight to the nearest 100gr by height to the nearest 0.5 cm. Furthermore, short-term changes in bone formation and bone resorption, as well as possible abnormalities in hormonal and biochemical metabolism of the bone are determined by serum levels of bone turnover markers. Next to minerals as calcium, phosphate and magnesium, procollagen type 1 C-terminal peptide (P1CP), the cross-linked telopeptide of type 1collagen (1CTP), parathyroid hormone (PTH), 25-hydroxyvitamin D (25OHD) and the growth hormone IGF-1 are being analysed. Ad 3) Daily physical activity levels will be monitored by the Actical accelerometer. The accelerometers will be initialized to collect data at 15 second intervals during 4 days, including 1 weekend day. Output (activity counts) will be downloaded to a PC after the monitoring period. In addition, a physical activity questionnaire will be administered. The final choice of questionnaire will be made during the preparatory phase of the study, based on careful review of literature and consultation with experts in physical activity measurement. Ad 4) Symptoms of depression will be assessed by the Children’s Depression Inventory (CDI). Ad 5) Health-related quality of life (HrQOL) will be assessed by child self-report and parent-proxy report using two questionnaires, | — |
Contacts
Public ContactK.I. Braam
VU University Medical Center, Department of Pediatrics, P.O. Box 7075
Outcome results
None listed