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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024308
Receipt No. R000027904
Scientific Title The verification of effect and feasibility of exercise education for hematologic cancer patients submitted to induction chemotherapy
Date of disclosure of the study information 2016/10/10
Last modified on 2017/10/06

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Basic information
Public title The verification of effect and feasibility of exercise education for hematologic cancer patients submitted to induction chemotherapy
Acronym The verification of effect and feasibility of exercise education for hematologic cancer patients submitted to induction chemotherapy
Scientific Title The verification of effect and feasibility of exercise education for hematologic cancer patients submitted to induction chemotherapy
Scientific Title:Acronym The verification of effect and feasibility of exercise education for hematologic cancer patients submitted to induction chemotherapy
Region
Japan

Condition
Condition Acute myelocytic leukemia
Acute lymphocytic leukemia
Malignant lymphoma
Classification by specialty
Hematology and clinical oncology Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of exercise education on physical activity and function
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The difference in physical activity pre- and post intervention
Key secondary outcomes The difference in physical function and activity of daily life between pre- and post intervention
The executing rate of exercise
The number of adverse events during observation period
The difference in psychological function, fatigue and quality of life between pre- and post intervention

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
Interventions/Control_1 Exercise education by a pamphlet
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed with these disease
*Acute myelocytic leukemia
*Acute lymphocytic leukemia
*Mantle cell lymphoma
*Diffuse large cell lymphoma with mutated both c-myc and bcl-2
*Burkitt's lymphoma
Inpatients planned to undergo induction chemotherapy (Kyoto university hospital)
20 years old or over
Patients being able to fill out questionnaire by themselves
Patients with written informed consent
Key exclusion criteria Patients who are not suitable for study inclusion based on the judgement of the primary phisician or the investigator
Patients with difficulty in communication due to a mental disorder or cognitive impairment
Patients with restrictions or contraindications to exercise due to a cardiovascular or respiratory disease
Patients having gait disorder by a musculoskeletal problem or neurological disease
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Tsuboyama
Organization Kyoto university
Division name Laboratory of Clinical Locomotor Science, Human Health Sciences, Graduate School of Medicine
Zip code
Address 53, Shogoin Kawaharacho, Sakyo-ku Kyoto-shi, Kyoto, Japan
TEL 0757513948
Email tsuboyama.tadao.4n@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Jike
Organization Kyoto university
Division name Laboratory of Clinical Locomotor Science, Human Health Sciences, Graduate School of Medicine
Zip code
Address 53, Shogoin Kawaharacho, Sakyo-ku Kyoto-shi, Kyoto, Japan
TEL 0757513948
Homepage URL
Email jike.atsushi.55m@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
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
2016 Year 10 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 15 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
2016 Year 10 Month 05 Day
Last modified on
2017 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027904

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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