Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT06856720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2025-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of NMES, Aerobic, and Resistance Exercise on Glycemic Control in Older Adults With Type 2 Diabetes
Sponsor:
Carlos Tavares
Organization:
Study Overview
Official Title:
Effects of Neuromuscular Electrical Stimulation and Aerobic and Resistance Exercise on Glycemic Control in Older Adults With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NMES4GliCon
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: