UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063155 |
|---|---|
| Receipt number | R000072284 |
| Scientific Title | Effects of Physical Therapy on Physical and Mental Function in Psychiatric Hospital Inpatients |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/10/02 17:28:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Physical Therapy on Physical and Mental Function in Psychiatric Hospital Inpatients
Acronym
Effects of Physical Therapy on Physical and Mental Function in Psychiatric Hospital Inpatients
Scientific Title
Effects of Physical Therapy on Physical and Mental Function in Psychiatric Hospital Inpatients
Scientific Title:Acronym
Effects of Physical Therapy on Physical and Mental Function in Psychiatric Hospital Inpatients
Region
| Japan |
Condition
Condition
Schizophrenia or Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of physical therapy on physical and mental function in patients with schizophrenia and patients with depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m walking speed and step length, One-leg standing time, Barthel Index, 5 times sit to standing time, Grip strength, Knee extension strength
Key secondary outcomes
Global Assessment of Functioning, Medication, Follow-up data on transition to community living, Nationwide version of the "Risk Assessment Scale for Need of Support and Long-term Care"
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Physical therapy consisting of range of motion exercises for the upper and lower limbs, lower limb muscle strengthening exercises, and standing and gait training
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Confirmed diagnosis: Patients diagnosed with schizophrenia or depression (mood disorder) by their attending psychiatrist based on ICD-10 or DSM-5.
Key exclusion criteria
Physical risk: Patients with serious physical or orthopedic conditions that contraindicate the exercises in (1) to (3), and patients with unstable cardiovascular disease.
Cognition and comprehension: Patients whom the principal investigator judged unable to understand instructions or perform exercises safely because of comorbid dementia or marked acute exacerbation of psychiatric symptoms.
Incomplete intervention: Patients discharged before completing the 12-week intervention period.
Difficulty with follow-up: Patients expected to have difficulty participating in the follow-up assessments at 4 and 8 weeks after discharge (e.g., discharge or transfer to a distant location, relocation overseas, or no available contact information).
Withdrawal of consent: Patients who withdrew their consent to participate during the study period.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Hirota |
Organization
Fujisawa Hospital
Division name
Department of Rehabilitation
Zip code
2518530
Address
383, Kotsuka, Fujisawa-shi, Kanagawa-ken
TEL
0466-23-2343
a-shonandai@outlook.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Ohira |
Organization
Shonan University of Medical Sciences
Division name
Somu-bu 4 General Affairs Department
Zip code
2440806
Address
16-48,Kamishinano, Totsuka-Ku, Yoohama-shi, Kanagawa Pref., Japan
TEL
045-821-0111
Homepage URL
soumu@sums.ac.jp
Sponsor or person
Institute
Shonan University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Shonan University of Medical Sciences
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
Research Ethics Committeeof Shonan University of Medical Sciences
Address
16-48,Kamishinano, Totsuka-Ku, Yokohama-shi
Tel
045-821-0111
soumu@sums.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
藤沢病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072284
