Status:
COMPLETED
Feasibility Study to Assess an Adapted Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Centre Leon Berard
Conditions:
Haematological Malignancy
Acute Leukemia
Eligibility:
All Genders
8-21 years
Phase:
NA
Brief Summary
Allogeneic haematopoietic stem cell transplantation (aHSCT) is the only curative treatment for many paediatric and young adult haematological pathologies (acute leukaemia, myelodysplastic syndromes ha...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05298930
Start Date
May 25 2022
End Date
July 31 2024
Last Update
August 21 2024
Active Locations (1)
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1
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, France, 69008