UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062829 |
|---|---|
| Receipt number | R000069349 |
| Scientific Title | Prevalence and Clinical Characteristics of Sarcopenia and Frailty, and the Effectiveness of Multidisciplinary Interventions in Community-Based Internal Medicine Outpatients: A Prospective Cohort Study with a Focus on Diabetes Mellitus |
| Date of disclosure of the study information | 2026/09/05 |
| Last modified on | 2026/09/05 10:52:49 |
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Basic information
Public title
A study on muscle mass and physical function in elderly outpatients and the effects of lifestyle interventions by a multidisciplinary team in a community clinic
Acronym
TRINITY-IM/DM Study
Scientific Title
Prevalence and Clinical Characteristics of Sarcopenia and Frailty, and the Effectiveness of Multidisciplinary Interventions in Community-Based Internal Medicine Outpatients: A Prospective Cohort Study with a Focus on Diabetes Mellitus
Scientific Title:Acronym
TRINITY-IM/DM (Full spell: Targeting Rehabilitation and Integrated Nutrition Intervention for Taming Yon-frailty in Internal Medicine and Diabetes Mellitus)
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Chronic Kidney Disease (including patients on hemodialysis), Chronic Heart Failure, Musculoskeletal Diseases (e.g., Osteoarthritis), Sarcopenia, Frailty, and Elderly Internal Medicine Outpatients
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objectives of the TRINITY-IM/DM Study are to evaluate the following three areas in a large-scale cohort of 2,400 elderly outpatients at a community-based internal medicine clinic:
1.Prevalence and Clinical Characteristics: To investigate the prevalence of sarcopenia and frailty and cross-sectionally analyze the impact of diabetes mellitus and its comorbidities (e.g., heart failure, end-stage renal disease, musculoskeletal diseases) on physical functional decline.
2.Prognostic Prediction and Longitudinal Changes: To longitudinally evaluate the impact of life events (e.g., disease onset, bereavement) on the natural progression of physical function and nutritional status (trajectory of decline), particularly in the very elderly aged 80 and over.
3.Effectiveness of Multidisciplinary Interventions: To verify the impact of comprehensive multidisciplinary interventions-involving physical therapists, registered dietitians, nurses, pharmacists, and clinical laboratory technicians-on the maintenance or improvement of physical function (deterioration buffering) and the recovery from malnutrition, utilizing a non-randomized controlled trial design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Change from baseline in the Short Physical Performance Battery (SPPB) total score: To evaluate the effectiveness of multidisciplinary interventions (physical therapy and nutritional counseling) and longitudinal changes, the primary outcome is defined as the mean change in the SPPB total score.
2.Prevalence and Incidence of Sarcopenia and Frailty: To identify the prevalence among 3,500 outpatients and the one-year incidence rate or reversion rate (from frailty to robust) in the elderly sub-group, particularly those aged 80 and over.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Physiotherapists will provide individual or small-group exercise guidance (e.g., resistance training) at a frequency of once a month to once every three months, accompanied by regular outcome assessments. Exercise interventions will include bodyweight exercises, beginning-movement load training machines, and cycle ergometers. Registered dietitians will provide nutritional counseling using dedicated pamphlets. For participants aged 60 and over, protein intake will be adjusted to a target of at least 1.2 g/kg (ideal body weight)/day for sarcopenia prevention. For participants in their 50s, nutritional guidance will focus on qualitative protein improvement and amino acid balance (e.g., leucine) to improve insulin resistance and maintain muscle quality, while carefully monitoring total energy intake.
Interventions/Control_2
[Control Arm: Standard of Care Group] Participants will continue to receive standard medical care at our clinic for diabetes and other underlying conditions (e.g., hypertension, dyslipidemia, chronic kidney disease). This includes regular physician consultations, blood tests, and general lifestyle advice. However, they will not receive individual exercise guidance from physical therapists, use of beginning-movement load training machines, or intensive individual nutritional interventions using dedicated pamphlets from registered dietitians.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria to be eligible for the study:
1. Age: Individuals aged 50 years or older at the time of providing informed consent.
2. Patient Status: Outpatients receiving continuous medical treatment or follow-up.
3. Gender: No restrictions on gender.
4. Physician Approval: Patients whose participation in the study has been approved by their primary care physician from a medical and physical standpoint.
5. Informed Consent: Patients who have received a thorough explanation of the study, demonstrated a full understanding of its contents, and provided voluntary written consent based on their own free will.
Key exclusion criteria
Individuals meeting any of the following criteria will be excluded from the study
1. Acute Physical Changes: Patients who have developed new musculoskeletal disorders or experienced a sudden decline in motor ability within the last month, which is the primary reason for their visit.
2. Implanted Medical Devices: Patients with implanted medical electrical devices, such as cardiac pacemakers (due to contraindications for Body Composition Analysis using the BIA method).
3. Medical Exercise Restrictions: Patients for whom exercise is contraindicated or restricted by their primary care physician due to complications such as cardiovascular disease, respiratory disease, or severe osteoporosis.
4. Other Inappropriate Conditions: Patients judged inappropriate for inclusion by the principal investigator for reasons such as severe cognitive impairment (dementia) affecting understanding, serious mental illness, or other factors that may compromise safety or data reliability.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Nishinakagawa |
| Middle name | |
| Last name | Tsuyoshi |
Organization
Kanisai Medical University
Division name
Faculty of Rehabilitation
Zip code
5731136
Address
Uyamahigashicho 18-89, Hirakata, Osaka, Japan
TEL
0728562361
kmu.nishinakagawa@gmail.com
Public contact
Name of contact person
| 1st name | NIshinakagawa |
| Middle name | |
| Last name | Tsuyoshi |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
5731136
Address
Uyamahigashicho 18-89, Hirakata, Osaka, Japan
TEL
0728562361
Homepage URL
kmu.nishinakagawa@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
Kansai Medical University
Address
Uyamahigashicho 18-89, Hirakata, Osaka, Japan
Tel
0728562361
kmu.nishinakagawa@gmail.com
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
| 2026 | Year | 09 | Month | 05 | 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
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 09 | Month | 05 | Day |
Last modified on
| 2026 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069349
