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Acute Graft Versus Host Disease

12 weeks moderate to high-intensity exercise program

Four 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

Experimental: moderate to high-intensity exercise

Sandra Goertz, B.Sc.

Miriam Götte, PhD

Lisa Maas, M.Sc

Miriam Götte, Phd

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.

The main objective of the POWER study is to investigate the effects of a 12-week moderate to high-intensity, partially supervised exercise program on cardiorespiratory fitness (VO2peak) in children and adolescents who have completed acute cancer treatment. This randomized controlled trial will include n=56 patients. Patients will be randomly assigned to the intervention or the control group. Patients in the intervention group will perform two supervised exercise sessions per week, one personal training session and one group-based training session. During an initial consultation, both groups receive recommendations for individual physical activity goals and a brochure with exercise recommendations as well as a fitness tracker to monitor their daily physical activity. Only the intervention group will receive daily activity targets, which will be adjusted on a regular basis. The study starts 6 weeks after completion of the patient's acute cancer treatment.

Secondary aims of this interventional study are to evaluate additional performance markers, including muscle strength, functional mobility, balance, body composition and patient-reported outcomes including QoL, fatigue, and cognitive function as well as blood markers to evaluate changes in metabolic, immune, and heart health.

Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

Effects of a Physical Activity Program On Cardiorespiratory Fitness in Children and Adolescents folloWing Acute cancER Treatment: a Randomized Controlled Trial

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).

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

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.

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

Body composition is assessed by bioimpedance analysis. Whole body resistance and reactance are measured using the BIA device Data Input Nutribox.

3. Change in level of physical activity (questionnaire and activity monitor) between both study arms at T1 and T2 and intra-individually

(PedsQL - Pediatric Quality of Life Inventory), change in Fatigue (Multidimensional Fatigue Inventory) and cognitive function (Ravens Progressive; WISC V - subtest memory; TAP ) between both study arms at T1 and T2 and intra-individually

CRP, BDNF, Insulin, Glukose, Adiponectin, Leptin, IL-1 beta, IL-2, IL-4, IL-6, IL-7, IL-8, IL-10, IL-15, IL 17a, TNF alpha, CRP, BDNF, IGF 1, MIF (macrophage migration inhibiting factor), IFN gamma, Troponin, NT-pro-BNP, between both study arms at T1 and T2 and intra-individually

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.	NCT04765020	All Types of Pe...	Experimental: m...	7 Years - 23 Years	Universität Duisburg-Essen
Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.	NCT04765020	All Types of Pe...	Experimental: m...	7 Years - 23 Years	Universität Duisburg-Essen

Spots Global Cancer Trial Database for all types of pediatric cancer