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
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
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
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
