Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment

Childhood Cancer Clinical Trial

— ONKOKIDS-HD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216604
• Other study ID #: S105-2011
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

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.

Locations

Country	Name	City	State
Germany	Children's Hospital of the University Hospital of Heidelberg	Heidelberg

Sponsors (5)

Lead Sponsor	Collaborator
German Cancer Research Center	Children`s Medical Hospital, University of Leipzig, Leipzig, Germany, Heidelberg University, University Hospital Heidelberg, University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility after 6 month	Will be measured as the proportion of patients following the exercise prescription.	after primary treatment (6 month)
Secondary	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
Secondary	Quality of Life	KINDL questionnaire	after primary treatment (6 month) and after one year
Secondary	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