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Completed

NCT Number: NCT02216604

Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment

Today about 80% childhood cancer patients become long-time survivors. In spite of the high cure rates the diagnosis cancer is associated with a variety of disease and treatment-related psychological and physical impairments mostly present into adulthood. So the attention has to focus on the improvement of these problems such as motor limitation, dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished quality of life (Qol). Although exercisel intervention studies in this field are generally scarce, the results of these studies are promising. Up to now studies during the acute phase of treatment are missing almost completely. The aim of this feasibility study is to evaluate the potential benefits of a modular exercise intervention program for childhood cancer patients startunf in parallel with treatment and longlasting for one year. Across two years cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21 years, free of any contraindications for physical activity will be recruited. All participants are asked to complete a physical assessment battery (strength, endurance and balance capacity, posture control, functional mobility, range of motion) and additionally two questionnaires concerning Qol and motivation, at baseline and every three months following one year

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Key information

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of the University Hospital of Heidelberg

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
  • date of diagnosis not longer than 8 weeks ago

Exclusion criteria

  • severe cardiac impairment
  • bone metastasis inducing skeletal fragility
  • other orthopedic diseases or any other circumstance that would impede ability to give informed consent or adherence to study requirements.

Treatment and study plan

Multimodal Exercise Intervention

Behavioral

During their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min. The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness. During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual. In addition, the patients obtain a movement diary and a pedometer for documenting their activity level.

Primary outcomes

  1. Feasibility after 6 month

    Time frame: after primary treatment (6 month)

    Will be measured as the proportion of patients following the exercise prescription.

Secondary outcomes

  1. Physical performance

    Time frame: after primary treatment (6 month) and after one year

    Strength (handheld dynamometer), endurance and balance capacity (TUDS, one leg stand), postural control functional mobility (posturomed & force plate), range of motion (goniometer)

  2. Quality of Life

    Time frame: after primary treatment (6 month) and after one year

    KINDL questionnaire

  3. Feasibility between 6 and 12 month

    Time frame: between end of primary treatment (6 month) and one year

    Will be measured as the proportion of patients following the exercise prescription.

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • Children's Medical Hospital, University of Leipzig, Leipzig, Germany
  • Heidelberg University
  • University Hospital Heidelberg
  • University of Leipzig

Registry information

Official study title

Physical Activity Intervention Program for Childhood Cancer Patients Under Chemo- and/or Radiation Therapy

Acronym: ONKOKIDS-HD

Important dates

Study start
2011
Primary completion
2018
Study completion
2019
First posted
Aug 15, 2014
Registry last updated
Mar 13, 2019

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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