NCT05289739

Brief Summary

The purpose of this multicenter study is to evaluate a personalised and standardised exercise intervention for children and adolescents undergoing anti-cancer treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

January 18, 2022

Last Update Submit

February 5, 2026

Conditions

Pediatric Oncology

Keywords

Paediatric exercise oncologyprecision exercise trainingchildhood cancerrandomized controlled trialquality of lifeaugmented realityexercise technology

Outcome Measures

Primary Outcomes (1)

  • Change in the score of Cancer-related fatigue during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline

    Cancer-related fatigue measured by the Pediatric Quality of Life Inventory (PedsQL) 3.0 Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale is composed of 18 items comprising three dimensions. Scores are transformed on a scale from 0 to 100. Higher scores indicate lower fatigue.

    pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention

Secondary Outcomes (42)

  • Change in the score of general Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline

    pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention

  • Change in the score of cancer-related Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline

    pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention

  • Change in the score of Mental Health (measured by WHO (Five) Well-Being Index) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline

    pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention

  • Change in the score of Mental Health (measured by Warwick-Edinburgh Mental Well-being Scale (WEMWBS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline

    pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention

  • Change in the score of Resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline

    pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention

  • +37 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Usual medical care + supervised exercise training during intensive medical treatment

Behavioral: Exercise training

Control group

NO INTERVENTION

Usual medical care

Interventions

Exercise trainingBEHAVIORAL

Exercise training during intensive cancer treatment. Training mainly consists of age-appropriate and personalized endurance, strength, flexibility, balance/coordination and gait training. Three to five weekly training sessions lasting 30 to 60 minutes each for about eight to ten weeks (depending on the course of the cancer treatment).

Exercise group

Eligibility Criteria

Age4 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • First/initial diagnosis of a primary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a relapsed oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a secondary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy
  • Planned or started anti-cancer treatment (chemo- and/or radiotherapy) at one of the recruiting centres of the FORTEe trial
  • The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as suitable to participate in the trial, e.g. due to medical or psychological reasons.
  • Existing informed consent (or assent) to participate in the study
  • The patient (and the legal guardian) has/have sufficient knowledge of the respective national or English language so that it is possible to carry out the informed consent as well as interviews (in age-appropriate language).
  • The patient is not in a terminal phase of the disease.

You may not qualify if:

  • Oncologic disease (primary/relapsed/secondary) according to the International Classification of Childhood Cancer (ICCC), requiring neither chemotherapy nor radiation therapy or solely requiring surgery
  • Reasons that already exist or are foreseeable at the time of study enrolment, due to which the patient will not have access to the exercise intervention and/or to the pre-test and/or to the post-test (e.g. foreseeable or planned, permanent change of treatment centre)
  • The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as unsuitable to participate in the trial, e.g. due to medical or psychological reasons.
  • After detailed information and, if necessary, having time to consider, the patient (≥ 16 years of age) did not agree to give written informed consent to participate in the trial.
  • The patient (and the legal guardians) has/have insufficient knowledge of the respective national or English language, so that it is not possible to carry out both the informed consent and interviews (in age-appropriate language).
  • The patient is in a terminal phase of the disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes-Gutenberg-University Medical Center

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (1)

  • Neu MA, Dreismickenbecker E, Lanfranconi F, Stossel S, Balduzzi A, Wright P, Windsor S, Wiskemann J, El-Rajab I, Lucia A, Fiuza-Luces C, Mongondry R, Fridh MK, Spreafico F, Konda B, Kitanovski L, Heisserer B, Polak M, Baader T, Bloch W, Gotte M; Network ActiveOncoKids; Rizvi K; Youth Cancer Europe; Ruckes C, Paul NW, Faber J; FORTEe Consortium. Get strong to fight childhood cancer - an exercise intervention for children and adolescents undergoing anti-cancer treatment (FORTEe): Rationale and design of a randomized controlled exercise trial. BMC Cancer. 2025 Aug 7;25(1):1275. doi: 10.1186/s12885-025-14489-y.

    PMID: 40775303DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jörg Faber, Univ.-Prof. Dr. med.

    Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr. med.

Study Record Dates

First Submitted

January 18, 2022

First Posted

March 21, 2022

Study Start

April 25, 2022

Primary Completion

January 26, 2026

Study Completion

January 26, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

DE(1)