Impact of NMES, Aerobic, and Resistance Exercise on Glycemic Control in Older Adults With Type 2 Diabetes
NCT ID: NCT06856720
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
105 participants
INTERVENTIONAL
2025-05-01
2026-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NMES Intervention Group
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).
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.
Exercise Intervention Group
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.
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.
Health Education Group
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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University of Salamanca
OTHER
Escola Superior de Tecnologia da Saúde de Coimbra
OTHER
Instituto Piaget
OTHER
Carlos Tavares
OTHER
Responsible Party
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Carlos Tavares
Effects of Neuromuscular Electrical Stimulation and Aerobic and Resistance Exercise on Glycemic Control in Older Adults with Type 2 Diabetes: A Randomized Controlled Trial
Central Contacts
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Other Identifiers
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NMES_T2DM_2025
Identifier Type: -
Identifier Source: org_study_id
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