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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
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.
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.
Participants will receive educational sessions on diabetes management, the role of exercise in glycemic control, and strategies to enhance adherence to physical activity.
Fasting Blood Glucose Levels
Measurement of fasting blood glucose levels using standardized blood collection and analysis.
Time frame: 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.
Time frame: Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).
Health-Related Quality of Life
Assessment of quality of life related to diabetes using the Audit of Diabetes Dependent Quality of Life - 18 (ADDQoL-18, Portuguese version) questionnaire. The ADDQoL-18 produces a weighted score ranging from -9 (worst possible quality of life) to +3 (best possible quality of life), with higher scores indicating better quality of life.questionnaire.
Time frame: Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).
Treatment Adherence Rates
Percentage of participants who complete the intervention sessions (NMES, exercise, or health literacy), measured through session attendance records.
Time frame: After 12 weeks of intervention.
Participant Satisfaction
Measurement of participant satisfaction with the intervention using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The DTSQ produces a total score ranging from 0 (lowest satisfaction) to 36 (highest satisfaction), with higher scores indicating greater satisfaction with the treatment.
Time frame: After 12 weeks of intervention.
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