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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06856720
• Lead Sponsor: Carlos Tavares

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Status Verified: 2025-03
• Study First Posted: 2025-03-04
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-03
• Study Start: 2025-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fasting Blood Glucose Levels	Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).	Measurement of fasting blood glucose levels using standardized blood collection and analysis.
Glycemic Control (HbA1c)	Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).	Measurement of hemoglobin A1c (HbA1c) levels using a blood test to assess long-term glycemic control.

Secondary Outcome Measures

Name	Time	Method
Health-Related Quality of Life	Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).	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.
Treatment Adherence Rates	After 12 weeks of intervention.	Percentage of participants who complete the intervention sessions (NMES, exercise, or health literacy), measured through session attendance records.
Participant Satisfaction	After 12 weeks of intervention.	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.