UMIN-CTR Clinical Trial

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

Acute myelocytic leukemia
Acute lymphocytic leukemia
Malignant lymphoma

Classification by specialty

Hematology and clinical oncology

Rehabilitation medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyoto University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院(京都府)

Date of disclosure of the study information

2016

Year

10

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

10

Month

05

Day

Last modified on

2017

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027904