UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046545 |
|---|---|
| Receipt number | 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 | 2024/01/08 15:22:10 |
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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 | Junya |
| Middle name | |
| Last name | Kanda |
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
jkanda16@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Murao |
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
masanobu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 05 | Day |
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
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053009
