sickle cell disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - patients with confirmed sickle cell disease. - willing to participate to the study (written informed consent).
Exclusion criteria
Exclusion criteria: - no transfusion for the 2 months proceeding the study. - no vaso-occlusive crisis or acute chest syndrome for the 3 months preceding the study. - absence of leg ulcer, osteonecrosis of the femoral head. - absence of any condition impairing walking gait. Patients presenting a median daily step-count over 9000 or an average daily step-count over 10.000 at the end of the baseline period are not allocated to one of the trial arms. Their baseline data will be treated in a cross-sectional analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - physical activity parameters (step-count, physical activity intensity), assessed daily and objectively using an activity tracker. - pain, assessed every day using a pain diary. - vaso-occlusive events and associated clinical signs. These primary outcomes are assessed on a minimum experimental period of 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| - level of physical activity, using questionnaires. - quality of life, using questionnaires. - walking speed. - cardio-vascular function (pulse wave velocity, hear rate variability). - hematological parameters. - biochemistry parameters. - inflammation parameters (cytokines, vascular adhesion molecules, micro-particles). - hemorheological parameters (blood and plasma viscosities). - sleep quality (assessed every day using an activity tracker). These secondary outcomes are assessed at the beginning or at the end of each 30-day experimental period (unless specified otherwise in the above). | — |
Countries
Japan,Europe,Africa
Contacts
Ochanomizu University Center for Interdisciplinary AI and Data Science