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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046545
Receipt No. R000053009
Scientific Title Association of between physical activity, skeletal muscle mass, and physical function and serum myokine levels in patients before and after allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2022/01/10
Last modified on 2022/01/04

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Basic information
Public title Circulating myokine levels in patients with allogeneic hematopoietic stem cell transplant patients
Acronym Circulating myokine levels in patients with allo-HSCT
Scientific Title Association of between physical activity, skeletal muscle mass, and physical function and serum myokine levels in patients before and after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Association of between physical activity, skeletal muscle mass, and physical function and serum myokine levels in patients before and after allo-HSCT
Region
Japan

Condition
Condition Blood disorders, Blood cancers
Classification by specialty
Hematology and clinical oncology Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the association of the circulating myokine levels with the skeletal muscle mass or physical function in patients with allogeneic hematopoietic stem cell transplantation.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum myokine levels
Key secondary outcomes Walking sped, 6-minute walk distance, Knee extensor strength, Body composition (skeletal muscle mass, fat mass), Thickness of quadriceps muscle, Cross sectional area of quadriceps muscle, Quality of quadriceps muscle, Physical activity

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Patients with underwent the allogeneic hematopoietic stem cell transplantation at Kyoto university hospital
Key exclusion criteria 1) Patients with higher brain dysfunction or other cognitive decline.
2) Patients who require assistance in activities of daily living.
3) Patients for whom the researcher or the physician in charge judges that it is difficult to conduct tests or interventions.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Kondo
Middle name
Last name Tadakazu
Organization Kyoto university hospital
Division name Department of Hematology and Oncology
Zip code 606-8507
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3111
Email tadakazu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Murao
Middle name
Last name Masanobu
Organization Kyoto university hospital
Division name Rehabilitation unit
Zip code 606-8507
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3111
Homepage URL
Email masanobu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 10 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2022 Year 02 Month 01 Day
Last follow-up date
2025 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2022 Year 01 Month 05 Day
Last modified on
2022 Year 01 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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