UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effective exercise programs for cancer fatigue
Title of the study (Brief title)	Examination of the effective exercise programs for cancer fatigue
Region	Japan

Condition
Condition	patients with hematological cancer
Classification by specialty	Hematology and clinical oncology Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1)explore the factors associated with fatigue of patients with hematological cancer 2)examine the effective exercise programs for fatigue of patients with hematological cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	autonomic nervous system by acceleration pulse wave method
Key secondary outcomes	1.muscle strength/walking ability 2.physical activity 3.anxiety/depression(HADS) 4.fatigue(cancer fatigue scale) 5.QOL(EORTC QLQ c-30)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Patients carried out one by one day the three types of intervention(rest,stretching,pedaling) for 10 minutes.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with hematologic cancer who scheduled for chemotherapy , they has been prescribed physical therapy
Key exclusion criteria	1)Considered inadequate by the investigator 2)Has severe complications 3)Has severe dysfunction(cardiac,respiratory,hapatic,renal) 4)Has diseases that affects physical activity (Cerebrovascular disease,Orthopedic disease) 5)Has dementia
Target sample size	36

Research contact person
Name of lead principal investigator	Shun Ishii
Organization	Nagasaki University Hospital
Division name	Department of Rehabilitation Medicine
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7258
Email	shun331@nagasaki-u.ac.jp

Public contact
Name of contact person	Shun Ishii
Organization	Nagasaki University Hospital
Division name	Department of Rehabilitation Medicine
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7258
Homepage URL
Email	shun331@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 27 Day
Anticipated trial start date	2016 Year 06 Month 27 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 06 Month 27 Day
Last modified on	2016 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026386