UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042826 |
|---|---|
| Receipt number | R000048880 |
| Scientific Title | Physical activity in patients with sickle cell disease: Effect on the vascular function, frequency of painful episodes and clinical course of the disease |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2020/12/24 15:00:37 |
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Basic information
Public title
Physical activity in patients with sickle cell disease
Acronym
drePAnon
Scientific Title
Physical activity in patients with sickle cell disease: Effect on the vascular function, frequency of painful episodes and clinical course of the disease
Scientific Title:Acronym
drePAnon
Region
| Japan | Europe | Africa |
Condition
Condition
sickle cell disease
Classification by specialty
| Medicine in general | Cardiology | Hematology and clinical oncology |
| Blood transfusion | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The primary objective is to understand the relationship between physical activity and the clinical expression of sickle cell disease. A secondary aim is to study the relationship between physical activity and the physiological factors known to be involved in the occurrence of vaso-occlusive events. Finally, the effect of an increase in physical activity on the course of the disease will be investigated.
Basic objectives2
Others
Basic objectives -Others
Improving care
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
- 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.
Key secondary outcomes
- 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).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Increase in the daily step-count by 25% compared to baseline, during the 2-month intervention period.
Interventions/Control_2
Increase in the daily step-count by 25% compared to baseline during one month of the intervention, and 50% compared to baseline during the second month.
Interventions/Control_3
No change in physical behaviors recommended.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- patients with confirmed sickle cell disease.
- willing to participate to the study (written informed consent).
Key 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Julien |
| Middle name | |
| Last name | Tripette |
Organization
Ochanomizu University
Division name
Center for Interdisciplinary AI and Data Science
Zip code
112-8610
Address
2-1-1 Otsuka, Bunkyo District, Tokyo, Japan
TEL
0339433151
tripette.julien@ocha.ac.jp
Public contact
Name of contact person
| 1st name | Julien |
| Middle name | |
| Last name | Tripette |
Organization
Ochanomizu University
Division name
Center for Interdisciplinary AI and Data Science
Zip code
112-8610
Address
2-1-1 Otsuka, Bunkyo District, Tokyo, Japan
TEL
0339433151
Homepage URL
https://www.ocha.ac.jp/index.html
tripette.julien@ocha.ac.jp
Sponsor or person
Institute
Ochanomizu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japanese
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan
Cheikh Anta Diop University, Dakar, Senegal
Lyon 1 University, Lyon, France
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Cheikh Anta Diop University of Dakar, Research Ethics Committee
Address
Faculte de Medecine, de Pharmacie et d'Odontologie - FMPO, Ancien Bureau de l'Ecole Doctoral "SEV" a cote du Nouveau Batiment, B.P. 5005, Dakar, Senegal
Tel
774677793
comite.ethique@ucad.edu.sn
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Ochanomizu University, Tokyo, Japan
National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan
Cheikh Anta Diop University, Dakar, Senegal
Lyon 1 University, Lyon, France
Unite Mixte Internationale (UMI 3189), 'Environnement, Sante, Societes' CNRS, Dakar, Senegal.
Institut de recherche biomedicale des armees, Departement Environnements Operationnels, Unite de Physiologie de l'Exercice et des Activites en Conditions Extremes, Bretigny-sur-Orge, France.
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 23 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048880
