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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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.
• Behavioral 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.
• Behavioral 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.

Primary outcome measures

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

Secondary outcome measures (5)

• Audit of Diabetes-Dependent Quality of Life (ADDQoL-18) [Time frame: 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) [Time frame: Week 12 (post-intervention)]
• Perceived Frequency of Hyperglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire) [Time frame: Week 12 (post-intervention)]
• Perceived Frequency of Hypoglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire) [Time frame: Week 12 (post-intervention)]
• Treatment Adherence [Time frame: Throughout 12-week intervention period]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Portugal · 1 center

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

Identifiers

NCT: NCT06856720 · NMES_T2DM_2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗