UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004015 |
|---|---|
| Receipt number | R000004816 |
| Scientific Title | Short-term and long-term effects of early exercise therapy on patients undergoing hematopoietic stem cell transplantation. |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2013/02/27 09:19:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Short-term and long-term effects of early exercise therapy on patients undergoing hematopoietic stem cell transplantation.
Acronym
Effects of exercise therapy on patients undergoing hematopoietic stem cell transplantation.
Scientific Title
Short-term and long-term effects of early exercise therapy on patients undergoing hematopoietic stem cell transplantation.
Scientific Title:Acronym
Effects of exercise therapy on patients undergoing hematopoietic stem cell transplantation.
Region
| Japan |
Condition
Condition
Malignant hematopoietic disease with the indication of an hematopoietic stem cell transplantation.
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Before, during and after hematopoietic stem cell transplamtation (HSCT), patients often experience enormous physical, psychological and psychosocial stress. Recently, exercise has been proposed as a non-pharmacologic adjuvant therapy to combat the physiological and psychological symptoms of HSCT. However, no studies have focused on the effects of exercise therapy on HSCT patients during the early phase of post-transplantation.
The purpose of this study is to evaluate the short-term and long-term effects of early exercise therapy on patients undergoing HSCT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Duration of posttransplant hospitalization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Exercise therapy
<Periods> about 2-3 months
<Length> 20-30 min/day
<Frequency> 5 day/week (except weekends)
Interventions/Control_2
usual care
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Maliginant hematopoietic disease with the indication of a HSCT
2.Patients aged 20 years or more
3.Good Japanese language skills
4.The written consent of the patient
Key exclusion criteria
1.Recent cardiovascular or pulmonary disease
2.Karnofsky performance scale 40% or less
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadao Tsuboyama |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
Address
Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriatsu Tatematsu |
Organization
Kyoto University
Division name
Human Health Science, Graduate School of Medicine
Zip code
Address
Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL
Homepage URL
noriatsu.t@ay4.ecs.kyoto-u.ac.jp
Sponsor or person
Institute
Human Health Science, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Human Health Science, Graduate School of Medicine, Kyoto University
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 08 | Day |
Last modified on
| 2013 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004816
