Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment

NCT02216604 | Completed

• 1 other identifier: S105-2011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Pediatric oncology; Physical Performance; Quality of Life; Feasibility; during primary; anticancer treatment

Outcome Measures

Primary Outcomes (1)

• Feasibility after 6 month

  Will be measured as the proportion of patients following the exercise prescription.

  after primary treatment (6 month)

Secondary Outcomes (3)

• Physical performance

  after primary treatment (6 month) and after one year

• Quality of Life

  after primary treatment (6 month) and after one year

• Feasibility between 6 and 12 month

  between end of primary treatment (6 month) and one year

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Multimodal Exercise Intervention

Control

NO INTERVENTION

age, disease and gender matched

Interventions

Multimodal Exercise Intervention 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.

Intervention group

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
• date of diagnosis not longer than 8 weeks ago

You may not qualify if:

• 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.

Sponsors & Collaborators

• German Cancer Research Center: lead
• University Hospital Heidelberg: collaborator
• Heidelberg University: collaborator
• University of Leipzig: collaborator
• Children's Medical Hospital, University of Leipzig, Leipzig, Germany: collaborator

Study Sites (1)

Children's Hospital of the University Hospital of Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Joachim Wiskemann, PhD

  National Center for Tumor Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: May 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

DE (1)