Impact of NMES, Aerobic, and Resistance Exercise on Glycemic Control in Older Adults With Type 2 Diabetes (NMES4GliCon)

Carlos Tavares

Status: Not yet enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Device: Neuromuscular Electrical Stimulation (NMES); Behavioral: Health literacy education; Behavioral: Aerobic and resistance exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06856720

NMES_T2DM_2025

Details and patient eligibility

About

This study aims to evaluate the effects of neuromuscular electrical stimulation (NMES), aerobic and resistance exercise, and health literacy intervention on fasting glucose levels and quality of life in older adults with type 2 diabetes (T2DM). Given the growing prevalence of T2DM in aging populations and the associated health risks, identifying effective interventions is crucial. The randomized controlled trial (RCT) will include participants aged 60+ with T2DM, randomly assigned to one of three groups: NMES, structured exercise, or a health literacy control group. Outcomes will be assessed at baseline, post-intervention (12 weeks), and follow-up (30, 60, and 90 days). The primary outcome is fasting glucose levels, while secondary outcomes include adherence, treatment satisfaction, and quality of life. This study seeks to provide evidence on alternative approaches for glycemic control in elderly individuals, particularly those with limited physical activity capacity.

Full description

This randomized controlled trial (RCT) investigates the effects of neuromuscular electrical stimulation (NMES), aerobic and resistance exercise, and a health literacy program on glycemic control and quality of life in older adults with type 2 diabetes mellitus (T2DM). Given the increasing prevalence of T2DM among the elderly and the challenges associated with its management, this study aims to evaluate alternative, accessible interventions that may improve metabolic health and overall well-being.

Study Design:

A parallel-group, randomized controlled trial with three intervention arms:

NMES Group: Participants will undergo NMES sessions targeting large muscle groups (quadriceps) for 30 minutes, three times per week over a period of 12 weeks. The stimulation parameters will be adjusted based on tolerability, following evidence-based protocols for improving glucose uptake.

Exercise Group: Participants will engage in a structured exercise program combining aerobic and resistance training, performed three times per week for 12 weeks under professional supervision. The protocol will follow international guidelines for T2DM exercise interventions.

Health Literacy Group: Participants will receive educational sessions on T2DM management, including lifestyle modifications, dietary recommendations, and glucose monitoring strategies.

Primary Outcome:

• Fasting glucose levels (measured at baseline, post-intervention, and follow-up at 30, 60, and 90 days).

Secondary Outcomes:

• Adherence to the intervention;
• Treatment satisfaction;
• Quality of life (measured using the ADDQoL-18 questionnaire);
• Impact of baseline physical activity level and functional capacity on intervention response;

Significance:

This study will explore the potential of NMES as an alternative or adjunct therapy for older adults with limited physical activity capacity. By comparing NMES with traditional exercise and health education, it will provide valuable insights into the feasibility, effectiveness, and long-term sustainability of these interventions for glycemic control in elderly populations with T2DM.

Enrollment: 105 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Type 2 Diabetes Mellitus (T2DM).
• Aged 60 years or older.
• Sufficient cognitive ability to understand study instructions.
• Institutionalized in nursing homes or similar settings.
• Willing and able to provide informed consent.

Exclusion criteria

• Severe cardiovascular diseases (e.g., heart failure, recent myocardial infarction).
• Musculoskeletal conditions that prevent exercise participation (e.g., severe arthritis, unhealed fractures).
• Intensive insulin therapy with high risk of hypoglycemia or significant glycemic control issues.
• Participation in other clinical trials that could interfere with this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

NMES Intervention Group

Experimental group

Description:

Participants in this arm will receive neuromuscular electrical stimulation (NMES) for 30 minutes, three times per week, for 12 weeks. The sessions will be supervised by a physical therapist. NMES will be applied to large muscle groups, such as the quadriceps, using specific parameters (5 Hz frequency, 400 μs pulse duration, 4 seconds stimulation on, 12 seconds rest off), adjusted to the maximum tolerable intensity for each participant. This group aims to evaluate the effect of NMES on glycemic control and quality of life in older adults with type 2 diabetes mellitus (T2DM).

Treatment:

Device: Neuromuscular Electrical Stimulation (NMES)

Exercise Intervention Group

Experimental group

Description:

Participants in this arm will engage in a combined aerobic and resistance exercise program three times per week for 12 weeks. The program will consist of 20 minutes of aerobic exercise (60-75% of maximum heart rate or moderate perceived effort) and 20 minutes of resistance training (50-70% of one-repetition maximum, focusing on large muscle groups). This exercise program will be supervised by a physical therapist and adapted to the participants' physical capabilities. This arm aims to compare the effects of exercise on glycemic control and quality of life in older adults with T2DM.

Treatment:

Behavioral: Aerobic and resistance exercise

Health Education Group

Active Comparator group

Description:

Participants in this arm will receive health education focused on diabetes management, including lifestyle changes and strategies for improving glycemic control. The sessions will be led by trained healthcare providers and will focus on diet, exercise, and self-management strategies. The goal is to assess the effects of health education on fasting glucose levels and quality of life in older adults with T2DM.

Treatment:

Behavioral: Health literacy education