UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058322 |
|---|---|
| Receipt number | R000066660 |
| Scientific Title | A Randomized Controlled Trial to Evaluate the Efficacy of Belt-Electrode Skeletal Muscle Electrical Stimulation for Improving Muscle Strength in Patients with Psychiatric Disorders. |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/30 18:59:01 |
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Basic information
Public title
A study on improving muscle strength for people with psychiatric disorders using electrical stimulation with a belt-type electrode.
Acronym
The BESP Study
Scientific Title
A Randomized Controlled Trial to Evaluate the Efficacy of Belt-Electrode Skeletal Muscle Electrical Stimulation for Improving Muscle Strength in Patients with Psychiatric Disorders.
Scientific Title:Acronym
The BESP Study
Region
| Japan |
Condition
Condition
Various psychiatric disorders
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether adding Belt-electrode Skeletal muscle Electrical Stimulation (B-SES) to standard physical therapy improves knee extension strength in patients with chronic psychiatric disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Knee extension strength at baseline (pre-intervention), 8 weeks, 12 weeks (end of intervention), and at 6-week follow-up.
Key secondary outcomes
The following outcomes assessed at baseline (pre-intervention), 12 weeks (end of intervention), and at 6-week follow-up:
Quality of life assessed by the Sarcopenia Quality of Life (SarQoL) questionnaire
Short Physical Performance Battery (SPPB)
Neuropsychiatric Inventory-Questionnaire (NPI-Q)
Medical Research Council (MRC) sum score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
B-SES Intervention Arm. In addition to standard physical therapy, an intervention with Belt-electrode Skeletal muscle Electrical Stimulation (B-SES) will be conducted. Device is G-TES1100 (B-SES belt). Duration is 12 weeks. Frequency is 3 times per week with 24 to 48 hour intervals. An adaptation period will be implemented for the first 3 weeks, starting at once per week with the lowest current intensity. Time per session is 30 minutes. Stimulation Settings are Frequency of 20Hz (muscle training soft mode), and Pulse width of 250 us. The current intensity (mA) will be set at each session to the maximum tolerance level for the participant without pain.
Interventions/Control_2
Contents of usual intervention (A, B, C, D, E are performed 3-4 times a week at the patient's choice)
A. Strength training (body weight or machine, Borg 12-13)
B. ADL movement training
C. Balance training
D. Ergometer: no load (pedaling only) or low load
E. Psychiatric occupational 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to psychiatric care wards who give consent to participate in the study, can clearly express their wishes, and have a prescription for rehabilitation.
Key exclusion criteria
Individuals who meet any of the following criteria will be excluded from the study:
Judged as unsuitable for participation by the attending physician.
Inability to provide informed consent for the study.
Severe hypertension (systolic blood pressure >= 200 mmHg or diastolic blood pressure >= 110 mmHg).
Presence of an implanted pacemaker.
History of epilepsy.
Presence of sensory disorders or skin lesions at the stimulation site.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Kakehashi |
Organization
Nandan Senyo-kai Minamiawaji Hospital, 560 Kashu Fukui, Minamiawaji City, Hyogo, Japan.
Division name
Rehabilitation Department
Zip code
656-516
Address
560 Kashu Fukui, Minamiawaji City, Hyogo, Japan
TEL
0799531553
kakehashi.tomoki@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Kakehashi |
Organization
Nandan Senyo-kai Minamiawaji Hospital
Division name
Rehabilitation Department
Zip code
656-516
Address
560 Kashu Fukui, Minamiawaji City, Hyogo, Japan
TEL
0799531553
Homepage URL
kakehashi.tomoki@hmw.gr.jp
Sponsor or person
Institute
Nandan Senyo-kai Minamiawaji Hospital,
Institute
Department
Personal name
Tomoki Kakehashi
Funding Source
Organization
Homer Ion Laboratory Co., Ltd.
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
Minami Awaji Hospital Ethics Committee
Address
560 Kashu Fukui, Minamiawaji City, Hyogo, Japan.
Tel
0799531553
info@minamihp.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
南淡千遙会 南淡路病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066660
