Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment

NCT ID: NCT02216604

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2019-03-31

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

Conditions

Childhood Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Multimodal Exercise Intervention

Intervention Type: 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.

Control

age, disease and gender matched

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

German Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Wiskemann, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Tumor Diseases

Locations

Children's Hospital of the University Hospital of Heidelberg

Heidelberg, , Germany

Countries

Germany

Other Identifiers

S105-2011

Identifier Type: -

Identifier Source: org_study_id