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

NCT06856720 | Enrolling By Invitation

• 1 other identifier: NMES_T2DM_2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Hyperglycemia Due to Type 2 Diabetes Mellitus; Aging

Keywords

Neuromuscular Electrical Stimulation; NMES; Exercise Training; Resistance Exercise; Aerobic Exercise; Health Literacy; Older Adults; Glycemic Control; Nursing Homes; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, weekly during the 12-week intervention period, and at 30-, 60-, and 90-day follow-up

Secondary Outcomes (5)

• 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

Study Arms (3)

Neuromuscular Electrical Stimulation

EXPERIMENTAL

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

Combined Aerobic and Resistance Exercise

ACTIVE COMPARATOR

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

Health Literacy Education

OTHER

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

Interventions

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.

Health Literacy Education

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.

Neuromuscular Electrical Stimulation

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.

Combined Aerobic and Resistance Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Nursing Homes and Long-Term Care Facilities in Central Portugal

Viseu, Viseu District, Portugal

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Carlos Tavares, PT, MSc

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Rui Gonçalves, PhD

  Polytechnic University of Coimbra

  STUDY DIRECTOR

• Rocío Llamas-Ramos, PhD

  University of Salamanca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1:1 ratio to one of three parallel intervention groups: neuromuscular electrical stimulation (NMES), supervised combined aerobic and resistance exercise, or structured health literacy intervention. All interventions will be delivered for 12 weeks.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: Access will be provided to researchers who submit a methodologically sound proposal. Requests will be reviewed by the study investigators. Data will be shared after approval, subject to ethical and legal requirements, and after signing a data access agreement.

Locations

PT (1)