UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001207 |
|---|---|
| Receipt number | R000001420 |
| Scientific Title | The study on physical fitness and rehabilitation in patients with hematopoietic stem cell transplantation (HSCT) |
| Date of disclosure of the study information | 2008/06/25 |
| Last modified on | 2012/10/23 13:36:20 |
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Basic information
Public title
The study on physical fitness and rehabilitation in patients with hematopoietic stem cell transplantation (HSCT)
Acronym
Physical fitness and rehabilitation in hematopoietic stem cell transplantation patients
Scientific Title
The study on physical fitness and rehabilitation in patients with hematopoietic stem cell transplantation (HSCT)
Scientific Title:Acronym
Physical fitness and rehabilitation in hematopoietic stem cell transplantation patients
Region
| Japan |
Condition
Condition
Patients receiving hematopoietic stem cell transplantation (HSCT)
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate longitudinal change of physical fitness and to verify the therapeutic effect of the rehabilitation program in patients with allogeneic hematopoietic stem cell transplantation (HSCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Grip strength
Key secondary outcomes
Exercise tolerance, Muscle function, Body flexibility, Ability for balance, Respiratory function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Rehabilitation program (including muscle strengthening exercise, endurance exercise and stretching exercise)
Period: from admission (Pre-HSCT) to discharge (post- HSCT)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving allogeneic HSCT in Keio University Hospital
Key exclusion criteria
1)Patients with severe motor dysfunction
2)Patients with severe complication
3)Other various conditions in which the attending doctor decide not suitable for entry
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aiko Ishikawa |
Organization
Graduate School of Keio University
Division name
Graduate School of Medicine, Doctoral Course
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University
Division name
School of Medicine, Dep. of Rehabilitation Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan.
TEL
03-5363-3833
Homepage URL
aishi@reha.med.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 06 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 24 | Day |
Last modified on
| 2012 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001420
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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