UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036819 |
|---|---|
| Receipt number | R000041740 |
| Scientific Title | Effects of guidance and the management of exercise to outpatients with hematological malignancies undergoing chemotherapy |
| Date of disclosure of the study information | 2019/05/22 |
| Last modified on | 2019/11/21 09:18:41 |
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Basic information
Public title
Effects of guidance and the management of exercise to outpatients with hematological malignancies undergoing chemotherapy
Acronym
Effects of guidance and the management of exercise to patients with hematological malignancies undergoing chemotherapy
Scientific Title
Effects of guidance and the management of exercise to outpatients with hematological malignancies undergoing chemotherapy
Scientific Title:Acronym
Effects of guidance and the management of exercise to patients with hematological malignancies undergoing chemotherapy
Region
| Japan |
Condition
Condition
Hematological Malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Inspecting of the effects of guidance and the management of exercise to outpatients with malignant lymphoma undergoing chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activity
Key secondary outcomes
Physical function
Physical symptom
Motor self-efficacy
Quality of lufe
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
guidance of home-exercise
Interventions/Control_2
management of home-exercise
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
outpatient who can exercise in home
outpatient who get permission of medical doctor
outpatient who agree the participation to this study after enough understanding
Key exclusion criteria
when the medical doctor do not agree
when physical status of the patient is bad
when the patient have severe heart disease
when the patient have severe ischemic disorder
when the patient can not communicate with researcher
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Naknao |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences (Health sciences)
Zip code
8528520
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
TEL
+81958197919
nakano-j@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Jiro |
| Middle name | |
| Last name | Naknao |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences (Health sciences)
Zip code
8528520
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
TEL
+81958197919
Homepage URL
nakano-j@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
nakano-j@nagasaki-u.ac.jp
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
Tel
+81958197919
nakano-j@nagasaki-u.ac.jp
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
長崎大学病院/Nagasaki University Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041740
