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NCT Number: NCT04765020

Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

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.

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Key information

Conditions

All Types of Pediatric Cancer Behavior Motor Activity

Age range

7 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Helios Klinik Krefeld

Krefeld, Germany

Location status: Recruiting

Location contact

Lisa Maas, M.Sc

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: moderate to high-intensity exercise

Behavioral

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

Other names: 12-week, partially supervised exercise program, general exericse recommendationy

Primary outcomes

  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 outcomes

  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

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Miriam Götte, PhD

CONTACT

[email protected]

+49 201 723 8083

Sandra Goertz, B.Sc.

CONTACT

[email protected]

+49 2151 32 45098

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

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

Registry information

Official study title

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

Acronym: POWER

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Feb 21, 2021
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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