An interventional study of Neuromuscular Electrical Stimulation and Combined Aerobic and Resistance Exercise in Type 2 Diabetes Mellitus, Hyperglycemia Due to Type 2 Diabetes Mellitus and Aging, sponsored by University of Salamanca. Enrolling by invitation at 1 site in Portugal. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by University of Salamanca · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Device: Neuromuscular Electrical Stimulation
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.
Behavioral: Combined Aerobic and Resistance Exercise
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.
Behavioral: Health Literacy Education
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.
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.
Structured education sessions delivered three times per week for 12 weeks focused on diabetes self-management, nutrition, physical activity, medication adherence, and glucose monitoring.
Weekly Mean Fasting Capillary Glucose
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.
Time frame: Baseline, weekly during the 12-week intervention period, and at 30-, 60-, and 90-day follow-up
Audit of Diabetes-Dependent Quality of Life (ADDQoL-18)
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.
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)
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.
Time frame: Week 12 (post-intervention)
Perceived Frequency of Hyperglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)
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.
Time frame: Week 12 (post-intervention)
Perceived Frequency of Hypoglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)
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.
Time frame: Week 12 (post-intervention)
Treatment Adherence
Adherence quantified as percentage of scheduled sessions attended (completed sessions out of 36 total scheduled sessions). Reasons for missed sessions recorded when available.
Time frame: Throughout 12-week intervention period
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications arising from this trial will be shared, including demographic variables, baseline characteristics, intervention allocation, outcome data, and statistical analysis datasets.
Supporting information: Study protocol, Sap, Icf, Analytic code
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University of Salamanca