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Enrolling by Invitation

NCT Number: NCT06856720

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nursing Homes and Long-Term Care Facilities in Central Portugal

Viseu, Viseu District, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

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.

Combined Aerobic and Resistance Exercise

Behavioral

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.

Health Literacy Education

Behavioral

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 outcomes

  1. Weekly Mean Fasting Capillary Glucose

    Time frame: 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.

Secondary outcomes

  1. 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

    Health-related quality of life assessed using the Portuguese validated version of the Audit of Diabetes-Dependent Quality of Life (ADDQoL-18). The ADDQoL-18 evaluates the perceived impact of diabetes on quality of life across multiple domains. Weighted impact scores range from -9 (maximum negative impact of diabetes on quality of life) to +3 (maximum positive impact), with lower scores indicating worse diabetes-related quality of life and higher scores indicating better quality of life.

  2. Overall Treatment Satisfaction (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)

    Time frame: Week 12 (post-intervention)

    Overall treatment satisfaction assessed using one item from a 3-item adapted questionnaire derived from the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Scores range from 0 to 6, with higher scores indicating greater satisfaction with current treatment.

  3. Perceived Frequency of Hyperglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)

    Time frame: Week 12 (post-intervention)

    Perceived frequency of unacceptably high blood glucose assessed using one item from a 3-item adapted questionnaire derived from the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Scores range from 0 to 6, with higher scores indicating greater perceived frequency of hyperglycemia.

  4. Perceived Frequency of Hypoglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)

    Time frame: Week 12 (post-intervention)

    Perceived frequency of unacceptably low blood glucose assessed using one item from a 3-item adapted questionnaire derived from the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Scores range from 0 to 6, with higher scores indicating greater perceived frequency of hypoglycemia.

  5. Treatment Adherence

    Time frame: Throughout 12-week intervention period

    Adherence quantified as percentage of scheduled sessions attended (completed sessions out of 36 total scheduled sessions). Reasons for missed sessions recorded when available.

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study 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

Acronym: NMES4GlyCon

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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