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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Weekly Mean Fasting Capillary Glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will remain blinded to group allocation throughout data collection. Participants and intervention providers cannot be blinded due to the nature of the interventions. Data analysts will also remain blinded to coded group allocation until completion of the primary analysis.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Health Literacy Education
Participants attend structured health literacy education sessions three times per week for 12 weeks focused on diabetes self-management, physical activity, nutrition, medication adherence, and glucose monitoring.
干预措施: Health Literacy Education (Behavioral)
Neuromuscular Electrical Stimulation
Participants receive bilateral quadriceps neuromuscular electrical stimulation three times per week, using surface electrodes applied bilaterally to the quadriceps muscles (5 Hz frequency, 400 μs pulse duration, 4 s ON / 12 s OFF duty cycle), for 12 weeks. Sessions last 30 minutes with progressive intensity to the maximum tolerable level.
干预措施: Neuromuscular Electrical Stimulation (Device)
Combined Aerobic and Resistance Exercise
Participants perform supervised combined aerobic and resistance exercise three times per week for 12 weeks. Each session lasts 30 minutes and includes warm-up, aerobic training, resistance exercises, and cool-down.
干预措施: Combined Aerobic and Resistance Exercise (Behavioral)
结局指标
主要结局
Weekly Mean Fasting Capillary Glucose
时间窗: Baseline, weekly during the 12-week intervention period, and at 30-, 60-, and 90-day follow-up
Mean fasting capillary blood glucose calculated from at least three fasting measurements per week when feasible during the intervention period, and assessed at 30-, 60-, and 90-day follow-up.
次要结局
- Audit of Diabetes-Dependent Quality of Life (ADDQoL-18)(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)(Week 12 (post-intervention))
- Perceived Frequency of Hyperglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)(Week 12 (post-intervention))
- Perceived Frequency of Hypoglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)(Week 12 (post-intervention))
- Treatment Adherence(Throughout 12-week intervention period)
研究者
Carlos Tavares
Principal Investigator
University of Salamanca