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

NCT06856720 | Not Yet Recruiting

• 1 other identifier: NMES_T2DM_2025
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Glycemic Control; Neuromuscular Electrical Stimulation; Type 2 Diabetes Mellitus; Aerobic Exercise; Resistance Training; Elderly Population; Diabetes Management; Health Literacy

Outcome Measures

Primary Outcomes (2)

• Fasting Blood Glucose Levels

  Measurement of fasting blood glucose levels using standardized blood collection and analysis.

  Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).

• Glycemic Control (HbA1c)

  Measurement of hemoglobin A1c (HbA1c) levels using a blood test to assess long-term glycemic control.

  Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).

Secondary Outcomes (3)

• Health-Related Quality of Life

  Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).

• Treatment Adherence Rates

  After 12 weeks of intervention.

• Participant Satisfaction

  After 12 weeks of intervention.

Other Outcomes (2)

• Baseline Physical Activity Level

  Baseline.

• Baseline Physical Fitness Level

  Baseline.

Study Arms (3)

NMES Intervention Group

EXPERIMENTAL

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).

Device: Neuromuscular Electrical Stimulation (NMES)

Exercise Intervention Group

EXPERIMENTAL

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.

Behavioral: Aerobic and resistance exercise

Health Education Group

ACTIVE COMPARATOR

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.

Behavioral: Health literacy education

Interventions

Neuromuscular Electrical Stimulation (NMES) DEVICE

Participants will receive NMES application for 30 minutes, three times a week, over a period of 12 weeks. The sessions will be supervised by a physiotherapist. Large muscle groups (quadriceps) will be used, with the following current parameters: frequency of 5 Hz, pulse width of 400 μs, 4 seconds of stimulation (on) for 12 seconds of rest (off), and intensity adjusted to the maximum tolerable level for the patient. These parameters are based on studies that have shown significant improvements in glycemic control and insulin sensitivity, especially in older adults with type 2 diabetes.

NMES Intervention Group

Aerobic and resistance exercise BEHAVIORAL

This group will participate in an exercise program combining aerobic and resistance activities, performed three times per week for 12 weeks. The activities will be adapted to the participants' physical capabilities and supervised by a physiotherapist. The program follows the international recommendations and it includes a 5-minute warm-up with flexibility exercises, 20 minutes of aerobic exercise at 60-75% of maximum heart rate or moderate perceived exertion, 20 minutes of resistance exercise at 50-70% of one-repetition maximum (1RM) focusing on large muscle groups (10-15 repetitions per exercise, 1-3 sets), and a 5-minute cool-down with static stretching and breathing exercises for relaxation.

Exercise Intervention Group

Health literacy education BEHAVIORAL

Participants will receive educational sessions on diabetes management, the role of exercise in glycemic control, and strategies to enhance adherence to physical activity.

Health Education Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos Tavares: lead
• University of Salamanca: collaborator
• Escola Superior de Tecnologia da Saúde de Coimbra: collaborator
• Instituto Piaget: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Carlos Tavares

CONTACT

+351912160753; carlos.tavares@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Effects of Neuromuscular Electrical Stimulation and Aerobic and Resistance Exercise on Glycemic Control in Older Adults with Type 2 Diabetes: A Randomized Controlled Trial

Model Details: This study is a randomized controlled trial (RCT) with three arms: 1) Neuromuscular Electrical Stimulation (NMES) group, 2) Aerobic and Resistance Exercise group, and 3) Health Literacy Group. Participants will be randomized to one of the three groups and undergo interventions for 12 weeks, with initial, final, and follow-up assessments at 30, 60, and 90 days to evaluate the efficacy and maintenance of effects.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03