Tokyo, Sept. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062829) titled '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' on Sept. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kansai Medical University

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 malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 3000

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069349

Disclaimer: Curated by HT Syndication.