| Project/Area Number |
19KK0248
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| Research Category |
Fund for the Promotion of Joint International Research (Fostering Joint International Research (B))
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| Allocation Type | Multi-year Fund |
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| Review Section |
Medium-sized Section 59:Sports sciences, physical education, health sciences, and related fields
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| Research Institution | Ochanomizu University |
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Principal Investigator |
tripette julien お茶の水女子大学, 文理融合 AI・データサイエンスセンター, 准教授 (30747481)
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| Co-Investigator(Kenkyū-buntansha) |
吉田 司 国立研究開発法人医薬基盤・健康・栄養研究所, 国立健康・栄養研究所 身体活動研究部, 研究員 (20822175)
宮地 元彦 国立研究開発法人医薬基盤・健康・栄養研究所, 国立健康・栄養研究所 身体活動研究部, 部長 (60229870)
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| Project Period (FY) |
2019-10-07 – 2023-03-31
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| Project Status |
Granted (Fiscal Year 2021)
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| Budget Amount *help |
¥17,030,000 (Direct Cost: ¥13,100,000、Indirect Cost: ¥3,930,000)
Fiscal Year 2022: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Fiscal Year 2021: ¥2,600,000 (Direct Cost: ¥2,000,000、Indirect Cost: ¥600,000)
Fiscal Year 2020: ¥8,710,000 (Direct Cost: ¥6,700,000、Indirect Cost: ¥2,010,000)
Fiscal Year 2019: ¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
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| Keywords | sickle cell disease / physical activity / accelerometer / pain / vaso-occlusive crisis / blood viscosity / vascular function / Africa / objective measurement / vascular adaptation / vaso occlusive crisis / sickle cell anemia / pilot study / pain diary / quality of life / intervention study / vascular physiology |
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| Outline of Research at the Start |
Sickle cell disease is a group of genetic blood disorders with fatal complications, which is mostly prevalent in Africa, Europa and the Americas. This research aims at establishing exercise guidelines to improve the quality of life of patients, in particular those living in developing countries.
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| Outline of Annual Research Achievements |
To date, clinical complications associated with sickle cell diseases (SCD) have never been studied relatively to the level of objectively measured physical activity (PA). By March 31, 2022, 85 subjects (65 patients and 20 healthy subjects) have been included in the study protocol. All subjects underwent a 5-week assessment of PA. The SCD patients have been submitted to a panel of tests aiming at assessing their clinical status and vascular health. They also completed a diary to record pain, potential vaso-occlusive painful events and related medications. Eighty-two subjects have completed the baseline assessment. Thirty patients have been included in a 3-month longitudinal protocol that includes a PA intervention and follow-up visits. Twenty-two of them have completed the whole longitudinal protocol. At baseline, the median daily step-count of patients are distributed from 3341 to 29643 steps. Some patients regularly performed more than 300 min per day of moderate-to-vigorous PA. Subjects with normal hemoglobin showed a similar range for step-count indicating that SCD patients can perform as much PA as their control counterpart. No relationship has been found between severe clinical events and the volume or intensity of PA. However, a significant negative correlation was found between daily step-count and pain occurrence in patients who did not report major clinical complications. In addition, we observed a negative correlation between the volume of PA and blood viscosity, which points to an improved hemorheological profile in the most active patients.
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| Current Status of Research Progress |
Current Status of Research Progress
4: Progress in research has been delayed.
Reason
Overall, the project is progressing rather smoothly. However, after 2.5 years of study, we observe a significant delay relatively to the initial schedule. This significant delay results from the accumulation of various issues: [1] Travels have not been possible at the beginning of the project due to the COVID-19 pandemics. Consequently, the data management protocol underwent several adaptations that slow down the work of clinicians and staffs in charge of the management of patients in Dakar. [2] These travel difficulties prevented Japanese collaborators from going to Dakar to dynamize the project on the data collection site. Similarly, the young Senegalese collaborators involved in the statistical analysis have not been able to travel to Japan in order to receive the necessary training on data analysis. [3] Unexpected issues related to internet access make the management of patients more challenging than expected. Subjects may loss access to internet for various reasons that include: finance, outdated device, location, travel, etc. Solving issues related to internet access would require budget credits that were not included in the initial plan. As a direct consequence, it is not possible to have more than 12 subjects enrolled at the same time in the protocol. Data quality is our top priority and will not be scarified to prioritize other management aspects. The recruitment of patients is not an issue, and we are therefore confident that we will enroll a sufficient number of subjects to make robust statistical analyses. We just need a little bit more time.
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| Strategy for Future Research Activity |
The enrollment of patients for both the cross-sectional and longitudinal observations is still on-going and will continue in 2022 and early 2023. Fifty-two subjects have been enrolled in 2021. Applying the same rate of enrollment to 2022 will bring the total number of subjects to 137. Considering the current ratio of inactive/active patients, a total of 137 patients allows reaching 45-60 inactive subjects included in the longitudinal study. Those numbers satisfy our targets. Most of the remaining budget will be allocated to the realizing of the blood test measurements at the end of 2022 or more certainly during 2023 after all subjects completed the study. Blood samples will be sent from Senegal to France, where assays will be performed (Lyon 1 University or French West Indies University). In addition to the enrollment of new patients, conductance of experimental visits and daily management of subjects, we plan to disseminate our preliminary findings. Robust analyses are currently performed for the first 50 subjects who completed the baseline observation period. Results will be submitted to a clinical journal in the first semester of 2022. Depending on the remaining budget and status of travel restrictions, Senegalese, French and Japanese collaborators will meet to discuss data analysis and future collaborations. Because of the delay observed in the collection of data, we need to extend the end of the project from March 2023 to March 2024. Continuing the project at the current pace leaves us confident that the data collection will meet the highest quality standards.
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