UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification of effect and feasibility of exercise education for hematologic cancer patients submitted to induction chemotherapy
Title of the study (Brief title)	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	Tadao Tsuboyama
Organization	Kyoto university
Division name	Laboratory of Clinical Locomotor Science, Human Health Sciences, Graduate School of Medicine
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	Atsushi Jike
Organization	Kyoto university
Division name	Laboratory of Clinical Locomotor Science, Human Health Sciences, Graduate School of Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027904