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JOURNAL ONKOLOGIE – STUDIE
POWER

Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

Rekrutierend

NCT-Nummer:
NCT04765020

Studienbeginn:
Juli 2021

Letztes Update:
30.06.2021

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Universität Duisburg-Essen

Collaborator:
Helios Hospital Krefeld, Oslo Centre for Biostatistics and Epidemiology, University Hospital, Essen,

Studienleiter

Miriam Götte, Phd
Principal Investigator
University Hospital, Essen

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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)

Exclusion Criteria:

- <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

Studien-Rationale

Primary outcome:

1. 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. (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
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 outcome:

1. Adverse events (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion)

2. Muscle strength (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
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

3. Functional mobility (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
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.

4. Static Balance (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
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

5. Body Composition (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
Body composition is assessed by bioimpedance analysis. Whole body resistance and reactance are measured using the BIA device Data Input Nutribox.

6. Change in level of physical activity (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
3. Change in level of physical activity (questionnaire and activity monitor) between both study arms at T1 and T2 and intra-individually

7. Change in Quality of Life (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
(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

8. Changes in serum markers (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
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

9. Changes in Echocardiography markers (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
M-Mode-Parameter

10. Changes in Echocardiography markers (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
Left ventricle end diastolic volume (LVEDV) in ml/m²

11. Changes in Echocardiography markers (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
Ejection Fraction (EF) in %

12. Changes in Echocardiography markers (Time Frame - At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion):
Tricuspid Annular Plane Systolic Excursion (TAPSE) in Millimeter

Studien-Arme

  • Experimental: Intervention group
    12 weeks moderate to high-intensity exercise program
  • No Intervention: Control group
    exercise recommendations

Geprüfte Regime

  • Experimental: moderate to high-intensity exercise (12-week, partially supervised exercise program / general exericse recommendationy / ):
    Four parts: Initial consultation with recommendations for general physical activity, brochure with exercise recommendations Once per week multi-modal group-based exercise (endurance, strength, mobility, coordination) Once per week supervised multi-modal individual training session (endurance, strength, mobility, coordination). Intensity: 60-80% of max. HR Activity trackers with individual movement goals that will be adjusted every two weeks

Quelle: ClinicalTrials.gov


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