Type 2 Diabetes MellitusNMES4GlyConNCT06856720
NMES, Exercise, and Glycemic Control in Older Adults With Type 2 Diabetes
A study testing Neuromuscular Electrical Stimulation, Combined Aerobic and Resistance Exercise and Health Literacy Education in people with Type 2 Diabetes Mellitus and Hyperglycemia Due to Type 2 Diabetes Mellitus, run by University of Salamanca at 1 site in Portugal.
Trial summary
Adults aged 60 years and older with type 2 diabetes living in nursing homes may experience difficulty participating in conventional exercise programs because of frailty, mobility limitations, or chronic health conditions. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hyperglycemia Due to Type 2 Diabetes Mellitus, Aging
- What is being tested?
- Neuromuscular Electrical Stimulation, Combined Aerobic and Resistance Exercise and Health Literacy Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Oct 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of type 2 diabetes mellitus.
- Age 60 years or older.
- Resident in a nursing home or similar long-term care facility in Portugal.
- Able to understand study procedures and provide informed consent.
- Stable antidiabetic medication regimen for at least 12 weeks before enrollment.
Who cannot join
- Severe cognitive impairment or inability to provide informed consent.
- Acute or unstable medical condition making participation unsafe.
- Contraindications to moderate-intensity exercise.
- Implanted electronic devices (e.g., pacemaker, implantable cardioverter-defibrillator).
- Skin lesions or dermatological conditions preventing safe electrode placement.
- Any condition judged by the clinical team to preclude safe participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Nursing Homes and Long-Term Care Facilities in Central Portugal
Viseu, Viseu District
About this study
Official title: Neuromuscular Electrical Stimulation Versus Combined Aerobic and Resistance Exercise Versus Health Literacy Intervention for Glycemic Control in Institutionalized Older Adults With Type 2 Diabetes: A Randomized Controlled Trial
Adults aged 60 years and older with type 2 diabetes living in nursing homes may experience difficulty participating in conventional exercise programs because of frailty, mobility limitations, or chronic health conditions. This randomized controlled trial compares three 12-week non-pharmacological interventions for glycemic management: neuromuscular electrical stimulation (NMES), supervised combined aerobic and resistance exercise, and a structured health literacy intervention. Participants will be randomly assigned to one of the three groups. The primary outcome is weekly mean fasting capillary glucose. Secondary outcomes include health-related quality of life, treatment satisfaction, adherence, and safety. The study aims to identify feasible and clinically relevant strategies for improving diabetes management in institutionalized older adults.
Read the detailed description
This randomized controlled trial investigates the comparative effectiveness of three non-pharmacological strategies for glycemic management in institutionalized older adults with type 2 diabetes mellitus living in nursing homes and long-term care facilities in Portugal.
Older adults residing in institutional settings frequently present with reduced mobility, frailty, multimorbidity, and reduced participation in conventional exercise programs. These factors contribute to impaired glycemic control and increased risk of diabetes-related complications. Although exercise is recommended as a core component of diabetes management, implementing structured exercise programs in institutionalized older populations may be challenging because of physical limitations, reduced functional capacity, and low adherence.
Neuromuscular electrical stimulation (NMES) has been proposed as a potential alternative or adjunctive intervention for individuals with limited tolerance to conventional exercise. By eliciting involuntary muscle contractions, NMES may promote metabolic and muscular adaptations associated with improved glucose regulation while requiring lower physical demand from participants. However, evidence regarding its effectiveness in institutionalized older adults remains limited.
This study compares NMES, supervised combined aerobic and resistance exercise, and a structured health literacy intervention focused on diabetes self-management and healthy behaviors. The inclusion of an educational comparator allows exploration of the relative contribution of physiological and behavioral approaches to glycemic management.
The trial is designed to evaluate the feasibility, acceptability, and potential clinical effectiveness of these interventions in real-world long-term care settings. The findings may contribute to the development of more accessible and adaptable non-pharmacological strategies for older adults with functional limitations and reduced exercise capacity.
- Being tested
- Neuromuscular Electrical Stimulation, Combined Aerobic and Resistance Exercise, Health Literacy Education
- Keywords
- Neuromuscular Electrical Stimulation, NMES, Exercise Training, Resistance Exercise, Aerobic Exercise, Health Literacy, Older Adults, Glycemic Control, Nursing Homes, Randomized Controlled Trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationDevice
Bilateral quadriceps neuromuscular electrical stimulation delivered three times per week for 12 weeks. Sessions last 30 minutes using surface electrodes with progressive intensity to the maximum tolerable level.
Combined Aerobic and Resistance ExerciseBehavioural
Supervised combined aerobic and resistance exercise delivered three times per week for 12 weeks. Each 30-minute session includes warm-up, aerobic training, resistance exercises, and cool-down.
Health Literacy EducationBehavioural
Structured education sessions delivered three times per week for 12 weeks focused on diabetes self-management, nutrition, physical activity, medication adherence, and glucose monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Electrical Stimulation | Experimental | Participants receive bilateral quadriceps neuromuscular electrical stimulation three times per week, using surface electrodes applied bilaterally to the quadriceps muscles (5 Hz frequency, 400 μs pulse duration, 4 s ON / 12 s OFF duty cycle), for 12 weeks. Sessions last 30 minutes with progressive intensity to the maximum tolerable level. Receives: Device: Neuromuscular Electrical Stimulation |
| Combined Aerobic and Resistance Exercise | Active comparator | Participants perform supervised combined aerobic and resistance exercise three times per week for 12 weeks. Each session lasts 30 minutes and includes warm-up, aerobic training, resistance exercises, and cool-down. Receives: Behavioral: Combined Aerobic and Resistance Exercise |
| Health Literacy Education | Other | Participants attend structured health literacy education sessions three times per week for 12 weeks focused on diabetes self-management, physical activity, nutrition, medication adherence, and glucose monitoring. Receives: Behavioral: Health Literacy Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Mean Fasting Capillary Glucose
Mean fasting capillary blood glucose calculated from at least three fasting measurements per week when feasible during the intervention period, and assessed at 30-, 60-, and 90-day follow-up.
Measured: Baseline, weekly during the 12-week intervention period, and at 30-, 60-, and 90-day follow-up
Secondary outcomes (5)
Audit of Diabetes-Dependent Quality of Life (ADDQoL-18)
Health-related quality of life assessed using the Portuguese validated version of the Audit of Diabetes-Dependent Quality of Life (ADDQoL-18). The ADDQoL-18 evaluates the perceived impact of diabetes on quality of life across multiple domains. Weighted impact scores range from -9 (maximum negative impact of diabetes on quality of life) to +3 (maximum positive impact), with lower scores indicating worse diabetes-related quality of life and higher scores indicating better quality of life.
Measured: Baseline, Week 12 (post-intervention), Day 30 follow-up, Day 60 follow-up, Day 90 follow-up
Overall Treatment Satisfaction (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)
Overall treatment satisfaction assessed using one item from a 3-item adapted questionnaire derived from the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Scores range from 0 to 6, with higher scores indicating greater satisfaction with current treatment.
Measured: Week 12 (post-intervention)
Perceived Frequency of Hyperglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)
Perceived frequency of unacceptably high blood glucose assessed using one item from a 3-item adapted questionnaire derived from the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Scores range from 0 to 6, with higher scores indicating greater perceived frequency of hyperglycemia.
Measured: Week 12 (post-intervention)
Perceived Frequency of Hypoglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)
Perceived frequency of unacceptably low blood glucose assessed using one item from a 3-item adapted questionnaire derived from the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Scores range from 0 to 6, with higher scores indicating greater perceived frequency of hypoglycemia.
Measured: Week 12 (post-intervention)
Treatment Adherence
Adherence quantified as percentage of scheduled sessions attended (completed sessions out of 36 total scheduled sessions). Reasons for missed sessions recorded when available.
Measured: Throughout 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start27 Oct 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel intervention groups: neuromuscular electrical stimulation (NMES), supervised combined aerobic and resistance exercise, or structured health literacy intervention. All interventions will be delivered for 12 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Tavares, University of Salamanca
- Investigators
- Carlos Tavares, PT, MSc, Principal investigator, University of SalamancaRui Gonçalves, PhD, Study director, Polytechnic University of CoimbraRocío Llamas-Ramos, PhD, Study chair, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856720
- Sponsor's protocol ID
- NMES_T2DM_2025
- Acronym
- NMES4GlyCon
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications arising from this trial will be shared, including demographic variables, baseline characteristics, intervention allocation, outcome data, and statistical analysis datasets.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation Versus Combined Aerobic and Resistance Exercise Versus Health Literacy Intervention for Glycemic Control in Institutionalized Older Adults With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06856720
- Acronym / sponsor ID
- NMES4GlyCon / NMES_T2DM_2025
- Keywords
- Neuromuscular Electrical Stimulation, NMES, Exercise Training, Resistance Exercise, Aerobic Exercise, Health Literacy, Older Adults, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adults aged 60 years and older with type 2 diabetes living in nursing homes may experience difficulty participating in conventional exercise programs because of frailty, mobility limitations, or chronic health conditions. This randomized controlled trial compares three 12-week non-pharmacological interventions for glycemic management: neuromuscular electrical stimulation (NMES), supervised combined aerobic and resistance exercise, and a structured health literacy intervention. Participants will be randomly assigned to one of the three groups. The primary outcome is weekly mean fasting capillary glucose. Secondary outcomes include health-related quality of life, treatment satisfaction, adherence, and safety. The study aims to identify feasible and clinically relevant strategies for improving diabetes management in institutionalized older adults.
Detailed description
This randomized controlled trial investigates the comparative effectiveness of three non-pharmacological strategies for glycemic management in institutionalized older adults with type 2 diabetes mellitus living in nursing homes and long-term care facilities in Portugal.
Older adults residing in institutional settings frequently present with reduced mobility, frailty, multimorbidity, and reduced participation in conventional exercise programs. These factors contribute to impaired glycemic control and increased risk of diabetes-related complications. Although exercise is recommended as a core component of diabetes management, implementing structured exercise programs in institutionalized older populations may be challenging because of physical limitations, reduced functional capacity, and low adherence.
Neuromuscular electrical stimulation (NMES) has been proposed as a potential alternative or adjunctive intervention for individuals with limited tolerance to conventional exercise. By eliciting involuntary muscle contractions, NMES may promote metabolic and muscular adaptations associated with improved glucose regulation while requiring lower physical demand from participants. However, evidence regarding its effectiveness in institutionalized older adults remains limited.
This study compares NMES, supervised combined aerobic and resistance exercise, and a structured health literacy intervention focused on diabetes self-management and healthy behaviors. The inclusion of an educational comparator allows exploration of the relative contribution of physiological and behavioral approaches to glycemic management.
The trial is designed to evaluate the feasibility, acceptability, and potential clinical effectiveness of these interventions in real-world long-term care settings. The findings may contribute to the development of more accessible and adaptable non-pharmacological strategies for older adults with functional limitations and reduced exercise capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel intervention groups: neuromuscular electrical stimulation (NMES), supervised combined aerobic and resistance exercise, or structured health literacy intervention. All interventions will be delivered for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Electrical Stimulation | Experimental | Device: Neuromuscular Electrical StimulationParticipants receive bilateral quadriceps neuromuscular electrical stimulation three times per week, using surface electrodes applied bilaterally to the quadriceps muscles (5 Hz frequency, 400 μs pulse duration, 4 s ON / 12 s OFF duty cycle), for 12 weeks. Sessions last 30 minutes with progressive intensity to the maximum tolerable level. |
| Combined Aerobic and Resistance Exercise | Active comparator | Behavioral: Combined Aerobic and Resistance ExerciseParticipants perform supervised combined aerobic and resistance exercise three times per week for 12 weeks. Each session lasts 30 minutes and includes warm-up, aerobic training, resistance exercises, and cool-down. |
| Health Literacy Education | Other | Behavioral: Health Literacy EducationParticipants attend structured health literacy education sessions three times per week for 12 weeks focused on diabetes self-management, physical activity, nutrition, medication adherence, and glucose monitoring. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of type 2 diabetes mellitus.
- Age 60 years or older.
- Resident in a nursing home or similar long-term care facility in Portugal.
- Able to understand study procedures and provide informed consent.
- Stable antidiabetic medication regimen for at least 12 weeks before enrollment.
Key exclusion criteria (6 listed)
- Severe cognitive impairment or inability to provide informed consent.
- Acute or unstable medical condition making participation unsafe.
- Contraindications to moderate-intensity exercise.
- Implanted electronic devices (e.g., pacemaker, implantable cardioverter-defibrillator).
- Skin lesions or dermatological conditions preventing safe electrode placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical StimulationBilateral quadriceps neuromuscular electrical stimulation delivered three times per week for 12 weeks. Sessions last 30 minutes using surface electrodes with progressive intensity to the maximum tolerable level. | Device | Neuromuscular Electrical Stimulation |
| Combined Aerobic and Resistance ExerciseSupervised combined aerobic and resistance exercise delivered three times per week for 12 weeks. Each 30-minute session includes warm-up, aerobic training, resistance exercises, and cool-down. | Behavioural | Combined Aerobic and Resistance Exercise |
| Health Literacy EducationStructured education sessions delivered three times per week for 12 weeks focused on diabetes self-management, nutrition, physical activity, medication adherence, and glucose monitoring. | Behavioural | Health Literacy Education |
Primary outcome
Weekly Mean Fasting Capillary Glucose
Time frame: Baseline, weekly during the 12-week intervention period, and at 30-, 60-, and 90-day follow-up
Mean fasting capillary blood glucose calculated from at least three fasting measurements per week when feasible during the intervention period, and assessed at 30-, 60-, and 90-day follow-up.
5 secondary outcomes
Audit of Diabetes-Dependent Quality of Life (ADDQoL-18)
Time frame: Baseline, Week 12 (post-intervention), Day 30 follow-up, Day 60 follow-up, Day 90 follow-up
Overall Treatment Satisfaction (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)
Time frame: Week 12 (post-intervention)
Perceived Frequency of Hyperglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)
Time frame: Week 12 (post-intervention)
Perceived Frequency of Hypoglycemia (3-item adapted questionnaire based on the Diabetes Treatment Satisfaction Questionnaire)
Time frame: Week 12 (post-intervention)
Treatment Adherence
Time frame: Throughout 12-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications arising from this trial will be shared, including demographic variables, baseline characteristics, intervention allocation, outcome data, and statistical analysis datasets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Tavares, PT, MSc principal investigator
University of Salamanca
Rui Gonçalves, PhD study director
Polytechnic University of Coimbra
Rocío Llamas-Ramos, PhD study chair
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation, Combined Aerobic and Resistance Exercise and Health Literacy Education in people with Type 2 Diabetes Mellitus and Hyperglycemia Due to Type 2 Diabetes Mellitus, run by University of Salamanca at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Mean Fasting Capillary Glucose (time frame: Baseline, weekly during the 12-week intervention period, and at 30-, 60-, and 90-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.