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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular Electrical Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, weekly during the 12-week intervention period, and at 30-, 60-, and 90-day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Tavares, PT, MSc | University of Salamanca | Principal Investigator |
| Rui Gonçalves, PhD | Polytechnic University of Coimbra | Study Director |
| RocÃo Llamas-Ramos, PhD | University of Salamanca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nursing Homes and Long-Term Care Facilities in Central Portugal | Viseu | Viseu District | Portugal |
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.
Beginning 6 months after publication of the primary results and ending 5 years after publication.
Access will be provided to researchers who submit a methodologically sound proposal. Requests will be reviewed by the study investigators. Data will be shared after approval, subject to ethical and legal requirements, and after signing a data access agreement.
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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.
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Outcome assessors will remain blinded to group allocation throughout data collection. Participants and intervention providers cannot be blinded due to the nature of the interventions. Data analysts will also remain blinded to coded group allocation until completion of the primary analysis.
| Combined Aerobic and Resistance Exercise | Behavioral | 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. |
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| Health Literacy Education | Behavioral | Structured education sessions delivered three times per week for 12 weeks focused on diabetes self-management, nutrition, physical activity, medication adherence, and glucose monitoring. |
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| 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. | 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. | 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. | 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. | Throughout 12-week intervention period |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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