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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021590
Receipt No. R000024898
Scientific Title Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Date of disclosure of the study information 2016/04/01
Last modified on 2018/03/25

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Basic information
Public title Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Acronym Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Scientific Title Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Scientific Title:Acronym Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Region
Japan

Condition
Condition Malignancy
Classification by specialty
Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study investigates the effects of physiotherapy and game equipment that focuses of physical function and psychological status in hematological malignancy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of activity,Knee extension strength,Grip strength,Timed Up and Go test,Functional Reach test,30 seconds chair stand test,Profile of Mood States Brief Form.
Evaluation time is performed before intervention starting for more than 30 minutes in the physiotherapy starting date, 1 week later and 2 weeks later.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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
Device,equipment
Interventions/Control_1 The control group estimates physical function and psychological status as the physiotherapy starting date,one week later,two week later. In addition, physical therapist(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.After that,Physical therapy in combination the game equipment(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.
Interventions/Control_2 The intervention group estimates physical function and psychological status as the physiotherapy starting date,one week later,two week later.In addition, Physical therapy in combination the game equipment do physiotherapy(Aerobic exercise, muscle strength training and balance practice, 20 minutes every day and Wii Fit U, 20 minutes every day) for one week.After that,physical therapist(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The hematological malignancy who enforces physiotherapy
Key exclusion criteria The person who require assistance to walk,The person who have complications to affect the gait remarkably,The person who has difficulty in self-entry of the question paper list,The person who has difficulty in instructions understanding by the language,The person that it is predicted that I cause a change and fatigue of remarkable vital signs at the time of an evaluation,The person whom a state is unstable from head to foot in
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name daiyu kobayashi
Organization Saitama Medical School synthesis medical center
Division name Rehabilitation
Zip code
Address 1981, Kamoda, Kawagoe-shi, Saitama
TEL 0492283529
Email kobayashidaiyu@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name daiyu kobayashi
Organization Saitama Medical School synthesis medical center
Division name Rehabilitation
Zip code
Address 1981, Kamoda, Kawagoe-shi, Saitama
TEL 0492283529
Homepage URL
Email kobayashidaiyu@yahoo.co.jp

Sponsor
Institute Saitama Medical School synthesis medical center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 04 Month 01 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 Completed
Date of protocol fixation
2016 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 30 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 03 Month 23 Day
Last modified on
2018 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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