Clinical Trial: Evaluation of Long-term Self-directed Exercise with Remote Monitoring for Glycemic Control in Type 2 Diabetes: An Exploratory Randomized Parallel-Group Trial (Japan)

Tokyo, Sept. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059091) titled 'Study on the Effects of Long-term Self-directed Exercise with Remote Monitoring on Blood Sugar Control in People with Type 2 Diabetes' on Sept. 17.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospita

Condition: Condition - Type 2 Diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Skeletal muscle plays a key role in glucose metabolism and the regulation of postprandial blood glucose. Age-related loss of muscle mass leads to decreased insulin sensitivity, contributing to impaired glucose metabolism and poor glycemic control. Resistance exercise has been shown to increase muscle mass and improve muscle function, and recent clinical trials have reported its beneficial effects on insulin resistance and glucose metabolism in patients with diabetes. However, in routine clinical practice, long-term adherence to exercise is often challenging, highlighting the need for effective intervention strategies. Therefore, this study aims to investigate the potential for improving glucose metabolism in patients with type 2 diabetes by implementing a system that remotely monitors patients' exercise and provides continuous support for sustained self-directed training. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Resistance exercise: Squats, 10 reps x 3 sets and balance exercise: Single-leg stance, 1 min per leg x 3 sets Frequency: At least 3 days per week Duration: 15 minutes per day Period: 1 year Interventions/Control_2 - Stretching exercises performed in sitting and standing positions Targeting four muscle groups: quadriceps, hamstrings, triceps surae, gluteus medius 8 exercises (60 seconds per side, left and right) Frequency: At least 3 days per week Duration: 10 minutes per day Period: 1 year

Eligibility: Age-lower limit - 50 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients attending the internal medicine outpatient clinic at Mito General Hospital with a diagnosis of type 2 diabetes Able to walk independently and perform activities of daily living (ADL) without assistance Able to provide informed consent for participation in the study Evaluated for physical function by a physical therapist at the outpatient clinic Own a personal smartphone and able to freely access YouTube at their discretion (anytime, anywhere) Able to view YouTube videos for approximately 15 minutes per day for 12 months using a smartphone (able to cover any data costs or expenses) Key exclusion criteria - A) Patients with any of the following diabetic complications: Proliferative diabetic retinopathy (patients stable after photocoagulation therapy are excluded) Heart failure NYHA (New York Heart Association) class II or higher B) Patients currently undergoing treatment for malignant tumors, including chemotherapy or radiation therapy (history of treatment only is allowed) C) Patients taking corticosteroids D) Patients with Cushing's syndrome or acromegaly, untreated or currently under treatment E) Patients who have undergone gastrectomy F) Patients with musculoskeletal disorders of the hip or knee resulting in inability to walk independently G) Patients with central nervous system disorders causing paralysis (including incomplete paralysis) H) Patients with neuropathy due to causes other than diabetes I) Patients with cognitive impairment that makes it difficult to follow instructions (including impaired communication ability) J) Patients with a history of regular exercise for more than 1 year For example, aerobic exercise for 30 minutes per day at least 3 times per week, or resistance exercise 2-3 times per week Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 20 Day Date of IRB - 2025 Year 09 Month 05 Day Anticipated trial start date - 2025 Year 09 Month 18 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067596

Disclaimer: Curated by HT Syndication.