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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

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 - HAPPY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033211
Enrollment
34
Registered
2024-06-18
Start date
2024-07-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C00-C97

Interventions

Group 1: Intervention Group After diagnosis, patients are screened to verify the inclusion and exclusion criteria for the study. For enrollment in the study, Test Time 0 (T0) is then performed with ba

Sponsors

Uniklinik Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Objectively measured physical activity Measured with: Accelerometer (Movisens) When: before the start of the intervention (T0) and after 3 months (end of intervention, T1)

Secondary

MeasureTime frame
Physical Fitness, Mental Health, Feasibility, Adherence

Countries

Germany

Contacts

Public ContactThorsten Simon

Uniklinik Köln

thorsten.simon@uk-koeln.de+49 221 478-40687

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026