ONKOKIDS-HD: Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment

Sponsor

German Cancer Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT02216604

Collaborator

University Hospital Heidelberg (Other), Heidelberg University (Other), University of Leipzig (Other), Children's Medical Hospital, University of Leipzig, Leipzig, Germany (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer	Behavioral: Multimodal Exercise Intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Feasibility after 6 month [after primary treatment (6 month)]
Will be measured as the proportion of patients following the exercise prescription.

Secondary Outcome Measures

Physical performance [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)
Quality of Life [after primary treatment (6 month) and after one year]
KINDL questionnaire
Feasibility between 6 and 12 month [between end of primary treatment (6 month) and one year]
Will be measured as the proportion of patients following the exercise prescription.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.