Feasibility Study to Assess an Adapted Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation (EVAADE)
Haematological Malignancy, Acute Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional supportive care trial for Haematological Malignancy
Eligibility Criteria
Inclusion Criteria:
- 8 years ≤ Age ≤ 21 years
- Height ≥ 110 cm
- Histologically or cytologically confirmed malignant or non-malignant haemopathy
- Indication for hematopoietic stem cell transplantation
- Hospitalization in a sterile room in the investigating center
- Certificate of no contraindicatication to practice an APA, issued by the oncologist or the attending physician
- Having a smartphone available in the sterile room (iOS version 12 (iPhone/Apple) or 6 under Android at least) for playing connected games
- Signed and dated written consent (patient or parents of minor patients with obtaining the minor's acceptance)
Exclusion Criteria:
- Severe heart disease and uncontrolled cardiovascular disease
Temporary contraindications
- Severe anemia (hemoglobin ≤ 8 g/dl) will need to be treated (transfusion of red blood cells [RBCs]) before resuming the physical activity program.
- Severe infectious syndrome in progress and/or febrile feeling with accompanying signs (productive cough, muscle pain).
Inclusion criteria for relatives :
- Person visiting the patient in a sterile room during the hospital stay
- At least 8 years old
- Height ≥ 110 cm
- Have a smartphone (iOS version 12 (iPhone/Apple) or 6 under Android at least) for the realization of the connected games.
- Not having any contraindication to physical activity.
- Signed and dated written consent (minor's relative or parents with the minor's acceptance).
Sites / Locations
- Institut d'Hématologie et d'Oncologie PédiatriqueRecruiting
Arms of the Study
Arm 1
Experimental
Physical activity intervention
The intervention will take place during the whole isolation phase and will consist of an APA program defined at inclusion, integrating supervised sessions with an APA teacher, as well as unsupervised sessions. The program will be individualized according to the patient's age, physical condition and PA preferences. The sessions will also be adapted to the biological, psychological and social parameters of the patients. The intervention will be carried out during the entire hospitalization period and for a maximum of 3 months. An connected bike will be installed in the patient's room for the duration of the hospitalization.