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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027597
Receipt No. R000031545
Scientific Title Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Date of disclosure of the study information 2017/08/01
Last modified on 2018/02/06

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Basic information
Public title Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Acronym Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Scientific Title Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Scientific Title:Acronym Effects of physical therapy intervention in every other day for schizophrenia patients who are unable to walk independently: A randomized controlled trial
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We determine the advantage of effects of physical therapy intervention in every other day, as compared with five times a week.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Barthel Index (BI)
-Bedside Mobility Scale (BMS)
-10m maximum walking test
-Range of Motion Test
-Grip strength Test
Key secondary outcomes -Brief Assessment of Cognition in Schizophrenia (BACS)
-Brief Psychiatric Rating Scale (BPRS)

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
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intervention: physical therapy intervention of three times a week by every other day
Interventions/Control_2 Control: physical therapy intervention of five times a 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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria -Patients who are unable to walk independently
-Patients who had a diagnosis of schizophrenia by DSM 1-5
-Patients whose written informed consent had obtained (from them or their proxies)
Key exclusion criteria -Advanced dementia
-After surgery such as trauma
-Dialysis
Target sample size 96

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Fuji
Organization Osaka University
Division name Public Health, Graduate School of Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL +81-6-6879-3911
Email yosshi511114@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Fuji
Organization Osaka University
Division name Public Health, Graduate School of Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL +81-6-6879-3911
Homepage URL
Email yosshi511114@yahoo.co.jp

Sponsor
Institute Department of Psychiatry, Osaka General Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 大阪急性期・総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 08 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 Terminated
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2018 Year 01 Month 26 Day
Date of closure to data entry
2018 Year 01 Month 26 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 01 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031545

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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