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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004015
Receipt No. 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

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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
Email

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
Email noriatsu.t@ay4.ecs.kyoto-u.ac.jp

Sponsor
Institute Human Health Science, Graduate School of Medicine, Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004816

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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