NMES, Exercise, and Glycemic Control in Older Adults With Type 2 Diabetes

Официальное название

Neuromuscular Electrical Stimulation Versus Combined Aerobic and Resistance Exercise Versus Health Literacy Intervention for Glycemic Control in Institutionalized Older Adults With Type 2 Diabetes: A Randomized Controlled Trial

Обзор

Adults aged 60 years and older with type 2 diabetes living in nursing homes may experience difficulty participating in conventional exercise programs because of frailty, mobility limitations, or chronic health conditions. This randomized controlled trial compares three 12-week non-pharmacological interventions for glycemic management: neuromuscular electrical stimulation (NMES), supervised combined aerobic and resistance exercise, and a structured health literacy intervention. Participants will be randomly assigned to one of the three groups. The primary outcome is weekly mean fasting capillary glucose. Secondary outcomes include health-related quality of life, treatment satisfaction, adherence, and safety. The study aims to identify feasible and clinically relevant strategies for improving diabetes management in institutionalized older adults.

Подробное описание

This randomized controlled trial investigates the comparative effectiveness of three non-pharmacological strategies for glycemic management in institutionalized older adults with type 2 diabetes mellitus living in nursing homes and long-term care facilities in Portugal.

Older adults residing in institutional settings frequently present with reduced mobility, frailty, multimorbidity, and reduced participation in conventional exercise programs. These factors contribute to impaired glycemic control and increased risk of diabetes-related complications. Although exercise is recommended as a core component of diabetes management, implementing structured exercise programs in institutionalized older populations may be challenging because of physical limitations, reduced functional capacity, and low adherence.

Neuromuscular electrical stimulation (NMES) has been proposed as a potential alternative or adjunctive intervention for individuals with limited tolerance to conventional exercise. By eliciting involuntary muscle contractions, NMES may promote metabolic and muscular adaptations associated with improved glucose regulation while requiring lower physical demand from participants. However, evidence regarding its effectiveness in institutionalized older adults remains limited.

This study compares NMES, supervised combined aerobic and resistance exercise, and a structured health literacy intervention focused on diabetes self-management and healthy behaviors. The inclusion of an educational comparator allows exploration of the relative contribution of physiological and behavioral approaches to glycemic management.

The trial is designed to evaluate the feasibility, acceptability, and potential clinical effectiveness of these interventions in real-world long-term care settings. The findings may contribute to the development of more accessible and adaptable non-pharmacological strategies for older adults with functional limitations and reduced exercise capacity.

Вмешательства

• Устройство Neuromuscular Electrical Stimulation
  Bilateral quadriceps neuromuscular electrical stimulation delivered three times per week for 12 weeks. Sessions last 30 minutes using surface electrodes with progressive intensity to the maximum tolerable level.
• Поведенческое Combined Aerobic and Resistance Exercise
  Supervised combined aerobic and resistance exercise delivered three times per week for 12 weeks. Each 30-minute session includes warm-up, aerobic training, resistance exercises, and cool-down.
• Поведенческое Health Literacy Education
  Structured education sessions delivered three times per week for 12 weeks focused on diabetes self-management, nutrition, physical activity, medication adherence, and glucose monitoring.

Первичные конечные точки

• Weekly Mean Fasting Capillary Glucose [Срок оценки: Baseline, weekly during the 12-week intervention period, and at 30-, 60-, and 90-day follow-up]

Вторичные конечные точки (5)

• Audit of Diabetes-Dependent Quality of Life (ADDQoL-18) [Срок оценки: Baseline, Week 12 (post-intervention), Day 30 follow-up, Day 60 follow-up, Day 90 follow-up]
• Overall Treatment Satisfaction (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire) [Срок оценки: Week 12 (post-intervention)]
• Perceived Frequency of Hyperglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire) [Срок оценки: Week 12 (post-intervention)]
• Perceived Frequency of Hypoglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire) [Срок оценки: Week 12 (post-intervention)]
• Treatment Adherence [Срок оценки: Throughout 12-week intervention period]

Критерии участия

Критерии включения

• Confirmed diagnosis of type 2 diabetes mellitus.
• Age 60 years or older.
• Resident in a nursing home or similar long-term care facility in Portugal.
• Able to understand study procedures and provide informed consent.
• Stable antidiabetic medication regimen for at least 12 weeks before enrollment.

Критерии исключения

• Severe cognitive impairment or inability to provide informed consent.
• Acute or unstable medical condition making participation unsafe.
• Contraindications to moderate-intensity exercise.
• Implanted electronic devices (e.g., pacemaker, implantable cardioverter-defibrillator).
• Skin lesions or dermatological conditions preventing safe electrode placement.
• Any condition judged by the clinical team to preclude safe participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Португалия · 1 центр

• Nursing Homes and Long-Term Care Facilities in Central Portugal — Viseu

Идентификаторы

NCT: NCT06856720 · NMES_T2DM_2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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