Evaluation of a combined supervised inpatient and online-home-based exercise pro-grams to promote physical activity behaviour in children and adolescents with oncological diseases undergoing medical therapy: HAPPY - a randomized controlled trail

Not Applicable

Recruiting

• Conditions: C00-C97; Malignant neoplasms

• Registration Number: DRKS00033211
• Lead Sponsor: niklinik Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

? Pediatric oncology patients (ICD10 C00-C97) who are undergoing inpatient and outpatient treatment at the Pediatric Oncology and Hematology Department of the University Hospital Cologne and are receiving systemic therapy
? New or recurrent diagnosis of a malignant disease with the need for intensive oncological therapy
? Patients with a curative and palliative treatment approach
? Diagnosis of the malignant disease was made no more than 12 weeks ago
? Oncological intensive therapy with a minimum duration of 3 months
? Age at inclusion = 6-17 years
? From the point of view of the treating physicians, participation in the study is possible
? Existence of the declaration of consent for study participation from the legal guardians and, depending on age, that of the patients

Exclusion Criteria

? Failure to meet the inclusion criteria
? Patient reaches the age of 18 in the next 3 months
? Isolated surgery without complementary systemic therapy
? Functional and/or cognitive impairment and/or orthopaedic complaints that do not allow participation in sports and exercise therapy
? Clinically manifest heart failure
? Partial or global respiratory insufficiency
? Symptomatic coronary heart disease
? Severe refractory hypertension
? Therapy-refractory thrombocytopenia < 10,000/µl
? Congenital or acquired thrombocytopathies or coagulation disorders
? Uncontrolled cerebral seizure disorder
? Physical or mental condition which, in the opinion of the investigator, does not permit sporting activity
? Participation in another sports/exercise study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Objectively measured physical activity<br>Measured with: Accelerometer (Movisens) <br>When: before the start of the intervention (T0) and after 3 months (end of intervention, T1)

Secondary Outcome Measures

Name	Time	Method
Physical Fitness, Mental Health, Feasibility, Adherence<br><br>