UMIN-CTR Clinical Trial

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
Email	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
Email	tripette.julien@ocha.ac.jp

Sponsor
Institute	Ochanomizu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048880