NCT07786194 Improvement Through Movement - Balance Control and Somatosensory Function in People With Diabetes Mellitus Type 2

Eligibility & Interventions

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This trial targets 48 participants in total. It began in 2025-11-13 with a primary completion date of 2027-07-31.

Brief Summary

This study focuses on improving balance control and somatosensory functions in individuals aged 60 years and older with diabetes mellitus tyoe 2 (DMT2). Older adults with DMT2 are at an increased risk of balance problems due to diabetic complications such as neuropathy, retinopathy, and possibly reduced vestibular function. The aim of the study is to investigate whether a 12-week exercise program, with or without additional balance exercises, can improve balance control, enhance somatosensory functions (such as touch and vibration thresholds), and positively impact diabetes-related parameters, including HbA1c levels. The study is designed as a randomized controlled trial (RCT). Participants are selected based on reduced balance control identified in a prior cross-sectional study. The intervention group follows an exercise program in accordance with international guidelines, supplemented with balance exercises supervised by the researcher (physiotherapist). The control group follows the same guidelines but without balance exercises; instead, they perform relaxation exercises. Balance control is assessed both statically and dynamically, while somatosensory functions are measured, and diabetes-related parameters are collected. The intervention is primarily home-based, supported by an activity tracker, but the balance or relaxation exercises are conducted under supervision at a designated location. This study aims to contribute to the quality of life of older adults with DMT2 by reducing balance problems and fall risks.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus * Age 60 years or older * Both men and women * Impaired balance control identified during the testing procedure for balance control, defined as a score of less than 30 seconds on the Standing on Foam with Eyes Closed test and/or less than 10 seconds on the Single Leg Stance with Eyes Open test * Able to understand the Dutch language. Exclusion Criteria: * A history of central neurological disease including stroke, multiple sclerosis, Parkinson's disease, dementia or intracranial tumor * Severe visual impairment such as blindness, cataract or glaucoma * Physical impairment which would preclude subjects from participating in an exercise /physical activity program (e.g. orthopedic conditions, severe cardiac conditions, uncontrolled hypertension etc.) * Need of physical or material support * HbA1c \< 7.5% (- the aim is to include patients with an HbA1c of \<7.5%, but if the treating endocrinologist considers an HbA1c value of 7.5 - 8% desirable for medical reasons, this patient will still be included) * Use of medication that can affect balance (e.g. sedatives, antidepressants, or antipsychotics) * Not understanding the Dutch language

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