Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment

Not Applicable

Completed

• Conditions: Childhood Cancer
• Interventions: Behavioral: Multimodal Exercise Intervention

• Registration Number: NCT02216604
• Lead Sponsor: German Cancer Research Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Primary Completion: 2018-12
• Status Verified: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention group	Multimodal Exercise Intervention	Multimodal Exercise intervention (console-based training, age-specific resistance training and body awareness)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

Children's Hospital of the University Hospital of Heidelberg; 🇩🇪 Heidelberg, Germany