Clinical trial NCT06856720: Impact of NMES, Aerobic, and Resistance Exercise on Glycemic Control in Older Adults With Type 2 Diabetes
Official title: Effects of Neuromuscular Electrical Stimulation and Aerobic and Resistance Exercise on Glycemic Control in Older Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: University of Salamanca
name: Escola Superior de Tecnologia da Saúde de Coimbra
name: Instituto Piaget
First posted: 2025-03-04
Enrollment: 105
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting Blood Glucose Levels
timeFrame: Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).
measure: Glycemic Control (HbA1c)
timeFrame: Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: Baseline, after 12 weeks of intervention, and at follow-ups (30, 60, and 90 days post-intervention).
measure: Treatment Adherence Rates
timeFrame: After 12 weeks of intervention.
measure: Participant Satisfaction
timeFrame: After 12 weeks of intervention.
Other outcomes:
measure: Baseline Physical Activity Level
timeFrame: Baseline.
measure: Baseline Physical Fitness Level
timeFrame: Baseline.
Locations:
Study officials:
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