About this trial
The POWER-study is a two-arm exercise intervention study for pediatric patients following acute cancer treatment. This clinical trial will investigate the effects of a 12-week moderate to high-intensity exercise program on cardiorespiratory fitness in children and adolescents beginning 6 weeks after completion of acute cancer treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and adolescents between 7 and 23 years of age
Completion of acute cancer treatment and receiving follow-up care in Krefeld (Helios Hospital Krefeld)
6 weeks post cancer-treatment
Signed informed consent (Parents and Patient)
Disqualifiers
<7 years of age, >23 years of age
Medical condition that limits participation in one of the study arms
Inability to follow the training-protocol
Inability to carry out the spiroergometry on a cycle ergometer
Trial design
Parallel
Treatments tested in this trial
Experimental: moderate to high-intensity exercise
BehavioralFour parts: 1. Initial consultation with recommendations for general physical activity, brochure with exercise recommendations 2. Once per week multi-modal group-based exercise (endurance, strength, mobility, coordination) 3. Once per week supervised multi-modal individual training session (endurance, strength, mobility, coordination). Intensity: 60-80% of max. HR 4. Activity trackers with individual movement goals that will be adjusted every two weeks
Treatment groups
Trial outcomes
Primary outcomes
Change in maximal oxygen uptake (VO2peak, ml/kg/min) from Baseline to T1 (end of intervention/12-weeks post randomization) between the two study groups, assessed in a maximal incremental exercise test (CPET) on a bicycle ergometer.
CPET is performed on an electronically braked cycle ergometer (Ergoline ergoselect 150 P) following the GDPK-Ergometry-Protocol). Ventilation and gas exchange data are determined breath-by-breath (Geratherm Respiratory Ergostik). VO2 peak is defined as the highest mean over 60 s and expressed on milliliters/kilogram/minute (ml/kg/min).
Secondary outcomes
Adverse events
Muscle strength
Change in maximal muscle strength (CITEC handheld dynamometer; expressed in Newton), balance (single leg stance; expressed in seconds), functional mobility (TUG 3m; expressed in seconds), and body composition (Data Input Nutribox) between both study arms from T0 to T1, T0 to T2 and T1 to T2
Functional mobility
Time (in sec) to complete the Timed Up and Go Test (TUG). The participants perform one test trial. The time of standing up, walking at a safe and comfortable pace to a mark 3 meters away from them, returning to the chair and sitting back down is recorded.
Static Balance
Single leg stance on a wooden bar, adapted by the MOON test, number of times the ground is touched during a one-minute test procedure
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universität Duisburg-Essen
Lead sponsor
Helios Hospital Krefeld
Collaborator
Oslo Centre for Biostatistics and Epidemiology
Collaborator
University Hospital, Essen
Collaborator