UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043976 |
|---|---|
| Receipt number | R000050226 |
| Scientific Title | The effect of rehabilitation combined exercise and nutrition therapy in patients with hematological malignancies |
| Date of disclosure of the study information | 2021/04/21 |
| Last modified on | 2021/10/22 16:39:28 |
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Basic information
Public title
The effect of rehabilitation combined exercise and nutrition therapy in patients with hematological malignancies
Acronym
Rehabilitation combined exercise and nutrition therapy in patients with hematological malignancies
Scientific Title
The effect of rehabilitation combined exercise and nutrition therapy in patients with hematological malignancies
Scientific Title:Acronym
Rehabilitation combined exercise and nutrition therapy in patients with hematological malignancies
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the physical function and QOL with exercise and nutrition therapy in patients with hematological malignancies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle strength(grip strength, knee extension strength) at admission and 3 months after admission
Key secondary outcomes
6 minute walk test, , physical activity, body composition, QOL, nutrition, fatigue, dietary intake, rehabilitation adherence, laboratory data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Other |
Interventions/Control_1
exercise therapy and nutrition therapy
Interventions/Control_2
exercise therapy
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with acute leukemia and malignant lymphoma who receive chemotherapy at Kita-Fukushima Medical Center. Furthermore, they were allowed to assess physical function test by hematologists
Key exclusion criteria
1.Patients don't be evaluated physical function due to muscle skeletal disease or cerebrovascular disease.
2.Patients don't be evaluated physical function due to complications
3.Patients don't be evaluated the questionnaire due to psycho social disease
4.Patients have impaired swallowing function who cannot take dietary supplements
5."Patients with eGFFR <40 ml / min / 1.73 m2" and "Patients who regularly use vitamin D preparations"
6.Patients who are allergic to milk and soybeans
7.Physician jugged inappropriate to participate this research
8.Patients did not obtain informed consent to this study
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Kasahara |
Organization
Kita-Fukushima Medical Center
Division name
Department of rehabilitation
Zip code
960-0502
Address
23-1 Aza-higashi, Hakozaki, Date-shi, Fukushima
TEL
024-551-0270
reha-ryu@jinsenkai.or.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Kasahara |
Organization
Kita-Fukushima Medical Center
Division name
Department of rehabilitation
Zip code
960-0502
Address
23-1 Aza-higashi, Hakozaki, Date-shi, Fukushima
TEL
024-551-0270
Homepage URL
reha-ryu@jinsenkai.or.jp
Sponsor or person
Institute
Kita-Fukushima Medical Center, Department of rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research Japan society of the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kita-Fukushima Medical Center
Address
23-1 Aza-higashi, Hakozaki, Date-shi, Fukushima
Tel
024-551-0270
inukai.takanori@jinsenkai.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2019-84
Org. issuing International ID_1
KIta-Fukushima Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 21 | 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 | 07 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050226
| Research Plan | |
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| Registered date | File name |
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