Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment (ONKOKIDS-HD)

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

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

Study Overview

• Status: Completed
• Conditions: Childhood Cancer
• Intervention / Treatment: Behavioral: Multimodal Exercise Intervention

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Children's Hospital of the University Hospital of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Multimodal Exercise intervention (console-based training, age-specific resistance training and body awareness)	Behavioral: Multimodal Exercise Intervention; 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.
No Intervention: Control; age, disease and gender matched

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility after 6 month	Will be measured as the proportion of patients following the exercise prescription.	after primary treatment (6 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical performance	Strength (handheld dynamometer), endurance and balance capacity (TUDS, one leg stand), postural control functional mobility (posturomed & force plate), range of motion (goniometer)	after primary treatment (6 month) and after one year
Quality of Life	KINDL questionnaire	after primary treatment (6 month) and after one year
Feasibility between 6 and 12 month	Will be measured as the proportion of patients following the exercise prescription.	between end of primary treatment (6 month) and one year

Collaborators and Investigators

• Sponsor: German Cancer Research Center
• Collaborators: University of Leipzig; Heidelberg University; University Hospital Heidelberg; Children's Medical Hospital, University of Leipzig, Leipzig, Germany
• Investigators: Principal Investigator: Joachim Wiskemann, PhD, National Center for Tumor Diseases

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Feasibility; Quality of Life; Pediatric oncology; Physical Performance; during primary; anticancer treatment
• Other Study ID Numbers: S105-2011