UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022894
Receipt number R000026386
Scientific Title Examination of the effective exercise programs for cancer fatigue
Date of disclosure of the study information 2016/06/27
Last modified on 2016/06/27 04:44:46

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Basic information

Public title

Examination of the effective exercise programs for cancer fatigue

Acronym

Examination of the effective exercise programs for cancer fatigue

Scientific Title

Examination of the effective exercise programs for cancer fatigue

Scientific Title:Acronym

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)


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



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

1st name
Middle name
Last name Shun Ishii

Organization

Nagasaki University Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7258

Email

shun331@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shun Ishii

Organization

Nagasaki University Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7258

Homepage URL


Email

shun331@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 27 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 06 Month 27 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026386


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name