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All Types of Pediatric CancerPhase 2/3POWERNCT04765020

Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

A Phase 2/3 study testing Experimental: moderate to high-intensity exercise in people with All Types of Pediatric Cancer, run by Universität Duisburg-Essen at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 7 to 23 years
Conditions the study is for
All Types of Pediatric Cancer
What is being tested?
Experimental: moderate to high-intensity exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteGermany
Study dates
21 Jun 2021to Jun 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 23 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • <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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sandra Goertz, B.Sc. contact

+49 2151 32 45098

sandra.goertz@helios-gesundheit.de

Miriam Götte, PhD contact

+49 201 723 8083

miriam.goette@uk-essen.de

Germany1 site, 1 recruiting

  • Helios Klinik Krefeld

    Krefeld

    Lisa Maas, M.Sc

    Recruiting

Other trials in Germany

About this study

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

Read the 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.

Being tested
Experimental: moderate to high-intensity exercise
Keywords
exercise, cardiorespiratory fitness, pediatric oncology, child health, physical activity, immune function
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: moderate to high-intensity exerciseBehavioural

    Also called 12-week, partially supervised exercise program, general exericse recommendationy

    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
Study groups in NCT04765020
Study groupRoleWhat they receive
Intervention groupExperimental12 weeks moderate to high-intensity exercise program
Receives: Behavioral: Experimental: moderate to high-intensity exercise
Control groupNo interventionexercise recommendations

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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).

    Measured: 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

Secondary outcomes (12)

  1. Adverse events

    Measured: 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

    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

    Measured: 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. 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.

    Measured: 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

  4. 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

    Measured: 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

  5. Body Composition

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

    Measured: 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

  6. Change in level of physical activity

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

    Measured: 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

  7. Change in Quality of Life

    (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

    Measured: 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

  8. Changes in serum markers

    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

    Measured: 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

  9. Changes in Echocardiography markers

    M-Mode-Parameter

    Measured: 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

  10. Changes in Echocardiography markers

    Left ventricle end diastolic volume (LVEDV) in ml/m²

    Measured: 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

  11. Changes in Echocardiography markers

    Ejection Fraction (EF) in %

    Measured: 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

  12. Changes in Echocardiography markers

    Tricuspid Annular Plane Systolic Excursion (TAPSE) in Millimeter

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start21 Jun 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04765020
Sponsor's protocol ID
HCRI ID 2020-0250
Acronym
POWER
Status last verified
May 2026
First submitted
26 Jan 2021
Last updated
15 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Experimental: moderate to high-intensity exercise in people with All Types of Pediatric Cancer, run by Universität Duisburg-Essen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sandra Goertz, B.Sc. (+49 2151 32 45098, sandra.goertz@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04765020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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