UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048253 |
|---|---|
| Receipt number | R000054996 |
| Scientific Title | Effect of Steroid Dose in Hematopoietic Stem Cell Transplantation on Standing and Stair Climbing |
| Date of disclosure of the study information | 2022/07/04 |
| Last modified on | 2023/07/04 09:31:31 |
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Basic information
Public title
Effect of Steroid Dose in Hematopoietic Stem Cell Transplantation on Standing and Stair Climbing
Acronym
Effect of Steroid Dose in Hematopoietic Stem Cell Transplantation on Standing and Stair Climbing
Scientific Title
Effect of Steroid Dose in Hematopoietic Stem Cell Transplantation on Standing and Stair Climbing
Scientific Title:Acronym
Effect of Steroid Dose in Hematopoietic Stem Cell Transplantation on Standing and Stair Climbing
Region
| Japan |
Condition
Condition
Hematopoietic stem cell transplant patients
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A study conducted at our hospital reported that steroid myopathy is caused by the administration of large doses of steroids to prevent graft-versus-host disease after hematopoietic stem cell transplantation.
Steroid myopathy is characterized by a predominant decrease in fast-twitch muscle fibers, and muscle weakness is often seen in the quadriceps and tibialis anterior muscles, which have a high ratio of fast-twitch muscle fibers.
Therefore, many patients after HSCT experience difficulty in standing up and walking up and down stairs, which require strength of the quadriceps muscle in particular.
No previous study has investigated the relationship between steroid dosage and the ability to stand up and climb stairs in HSCT patients.
We believe that clarifying the actual status of these impaired movement abilities will motivate patients to practice movement and strengthen their muscles at an early stage.
The purpose of this study was to clarify the relationship between steroid dosage and changes in ability to stand up and climb stairs, muscle strength, and skeletal muscle mass before and after HSCT in HSCT patients with the aim of proposing items associated with decreased movement ability.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-second chair rise test (evaluated before transplantation, after engraftment (approximately 3 weeks after transplantation), and at discharge)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients 18 years of age or older who are scheduled for hematopoietic stem cell transplantation and request physical therapy at this hospital.
Key exclusion criteria
Patients with severe cardiac disease, bone tumors with a risk of fracture, patients with unrelated diseases that make it difficult to assess lower limb function, patients in poor general condition that makes it difficult to assess physical function, patients with unsuccessful transplants such as failure of implantation, and relapsed cases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuyoshi |
| Middle name | |
| Last name | Nishikado |
Organization
Hyogo Medical University Hospital
Division name
rehabilitation
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo
TEL
0798456111
nnishikado@gmail.com
Public contact
Name of contact person
| 1st name | Nobuyoshi |
| Middle name | |
| Last name | Nishikado |
Organization
Hyogo Medical University Hospital
Division name
rehabilitation
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo
TEL
0798456111
Homepage URL
nnishikado@gmail.com
Sponsor or person
Institute
Hyogo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
MEXT
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
Hyogo Medical University Hospital
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo
Tel
0798456111
unknown
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 | 07 | Month | 04 | 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
| 2022 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054996
