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NOT YET RECRUITING
NCT06856720
NA

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

Sponsor: Carlos Tavares

View on ClinicalTrials.gov

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.

Official title: Effects of Neuromuscular Electrical Stimulation and Aerobic and Resistance Exercise on Glycemic Control in Older Adults With Type 2 Diabetes

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-05-01

Completion Date

2026-05-01

Last Updated

2025-04-03

Healthy Volunteers

No

Interventions

DEVICE

Neuromuscular Electrical Stimulation (NMES)

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.

BEHAVIORAL

Aerobic and resistance exercise

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.

BEHAVIORAL

Health literacy education

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