UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048435 |
|---|---|
| Receipt number | R000055197 |
| Scientific Title | Dietary guidance and walking exercise therapy for patients with psychotic disorders |
| Date of disclosure of the study information | 2022/07/22 |
| Last modified on | 2022/07/22 16:01:59 |
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Basic information
Public title
Dietary guidance and walking exercise therapy for patients with psychotic disorders: an open-label study
Acronym
Dietary guidance and walking exercise therapy for patients with psychotic disorders: an open-label study
Scientific Title
Dietary guidance and walking exercise therapy for patients with psychotic disorders
Scientific Title:Acronym
Dietary guidance and walking exercise therapy for patients with psychotic disorders
Region
| Japan |
Condition
Condition
Psychotic disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dietary guidance and walking exercise therapy for patients with psychotic disorders
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight and body composition measurement (InBody470)
Key secondary outcomes
Clinical Global Impressions - severity of illness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dietary guidance/Walking exercise therapy
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. patients who, after receiving full explanation and with full understanding, give written consent of their own free will to participate in this study
2. patients who are between 20 and 65 years of age at the time of consent
3. patients with clinically stable psychiatric symptoms
4. patients who are capable of performing walking exercise therapy (10,000 steps/day, at least 5 days/week)
5. patients with BMI >25
Key exclusion criteria
1. patients with serious physical illnesses
2. pregnant, lactating or planning to become pregnant
3. patients with blood pressure that is not stabilized due to hypertension of the third degree (blood pressure of 180/100 mg HG or higher)
4. patients with a history of cerebrovascular disease or with signs and symptoms that suggest such a disease
5. patients with suicidal ideation or suicidal attempts
6. patients with signs and symptoms of acute inflammation of the musculoskeletal system in the locomotor area
7. patients with diabetes mellitus
8. other patients who are deemed inappropriate by the Principal Investigator or Principal Investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kishi |
| Middle name | |
| Last name | Taro |
Organization
Fujita Health University School of Medicine
Division name
Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562939250
tarok@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kishi |
| Middle name | |
| Last name | Taro |
Organization
Fujita Health University School of Medicine
Division name
Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562939250
Homepage URL
tarok@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
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
Fujita Health University School of Medicine
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | 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
21
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
| 2021 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055197
