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| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
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One-center randomized, three-arm, parallel, superiority, controlled trial in 132 elderly outpatients with type 2 diabetes. Two different combined exercise training doses (300min/week vs 150min/week) will be compared against usual care. The entire study length will last 24 weeks, and assessments will be conducted at baseline, previously to the group allocation, at 12 weeks and at 24 weeks just after the treatments' end. The study's primary outcome is the glycated hemoglobin level at 24 weeks. Secondary outcomes of clinical relevance to type 2 diabetes and elderlies will also be acquired.
This study is a randomized controlled trial, three-arm parallel-group. The first aim is to evaluate the efficacy of a supervised and structured combined exercise training program in HbA1c levels at 24 weeks. Secondary outcomes measurements of clinical relevance for type 2 diabetes and elderly patients are included at 12 and 24 weeks.
The investigators will enroll 132 elderlies divided into three experimental groups, randomized in a ratio of 1:1 (44 patients per group). The treatments arms comprises structured supervised combined exercise training programs, three times a week, lasting 24 weeks of duration. The G150 group will exercise 150 min per week of aerobic and strength training (50 min per session, 25 min for each modality) and the G300 group will exercise twice the volume in the same G150's intensity, and week frequency (100 min per session, 50 min for each modality). No intervention will be offered to the control group (i.e., they will continue their usual care). Treatments arms will progress on training load tailored by their maximal heart rate percentage for aerobic training and maximal repetitions for strength training.
The sample size was calculated considering a between-group mean difference of 0.45%, with standard deviation of 0.7% in HbA1c levels, for an 80% of statistical power and 5% of type 1 error, in a superiority hypothesis design.
In detail, the primary outcome is the HbA1c level at 24 weeks, an secondary outcomes are: HbA1c levels at 12 weeks; office blood pressure assessed through a digital sphygmomanometer at 12 and 24 weeks; lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) at 24 weeks; endothelial function assessed by flow-mediated dilation at 12 and 24 weeks; intima-media thickness at 24 weeks; physical fitness assessed by maximal oxygen uptake and maximal muscle strength at 24 weeks; body composition assessed by dual x ray absorptiometry at 24 weeks; quality of life and geriatric depressive symptoms assessed by questionnaires at 24 weeks.
The investigators hypothesized that the G300 will greater improve the 24-week HbA1c levels and secondary outcomes against the G150 and the control group. The present study was designed and will be conducted by a multidisciplinary staff, and follows ethical and methodological standards for randomized clinical trials. As for empirical evidence provision, it is expected to highlight the efficacy of the non-pharmacological treatment for type 2 diabetes in the elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants randomized to this group will perform monthly cohabitation meetings. | |
| G150 | Experimental | Participants randomized to this group will be enrolled to a 150 min/week structured and supervised exercise training. The program consists of 3 sessions in a week, each of these lasting 50 minutes. The session will be composed of aerobic training (25 minutes at 60-75% of HRmax) and strength training (25 minutes, 8 whole-body exercises at up to 8-12 maximal repetitions). |
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| G300 | Experimental | Participants randomized to this group will be enrolled to the same structural settings of G150 group (type of exercise, exercise intensity and weekly frequency). They will receive twice the G150 group dose's. To do so, each session will last 100 minutes (50 minutes of aerobic exercise training and 50 minutes of strength training). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G150 | Behavioral | This group will receive 150 min/week of combined exercise training, structured and supervised. |
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| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Glycated hemoglobin in DCCT units (%) | Change from baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Glycated hemoglobin in DCCT units (%) | Change from baseline to 12 weeks |
| Office Blood Pressure | Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angélica De Nardi, MSc | Contact | +55 51 3359-6332 | atnardi@hcpa.edu.br | |
| Lucinéia Pfeifer, MSc | Contact | +55 51 3359-6332 | lpfeifer@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Umpierre, PhD | Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul | Principal Investigator |
| Beatriz Schaan, MD, PhD | Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
Data HbA1c and neuromuscular function and any deemed relevant support information (sociodemographic, clinical history and allocated groups) will be shared if available. Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol. Data on other outcomes could be requested contacting the PI. Data access will be available after all participants completed the study and will remain accessible for as long as deemed necessary by the study's committee. Data sets, variables' dictionary and statistical analysis description will be made available online upon registration at a clinical trial management system nested to the EDDIE Study's website (www.ufrgs.br/eddie), and the access will be permitted after acceptance of the EDDIE Study team's data sharing terms and policy.
The individual participant dataset will become available up to six months after the first study publication.
A simple registration aside a policy acceptance term will grant access to study's datasets.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| G300 | Behavioral | This group will receive 300 min/week of combined exercise training, structured and supervised. |
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| Change from baseline to 12 weeks |
| Office Blood Pressure | Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg | Change from baseline to 24 weeks |
| Lower limbs functional capacity | By using the Short Physical Performance Battery (SPPB), lower-limb mobility will be assess in the following sequence: static standing balance, walking speed and indirect muscle strength. The performance of functional activities will be converted to a standardized scale from 0 (poor functional capacity) to 12 points (excellent functional capacity) | Change from baseline to 24 weeks |
| Cardiorespiratory fitness | Peak oxygen uptake (VO2peak) assessed by maximal cardiopulmonary exercise testing and reported in its weighted form (ml/kg/min) | Change from baseline to 24 weeks |
| Geriatric Depression Symptoms | Geriatric depression alertness and improvements will be assessed through a questionnaire comprised by 15 questions in a YES/NO answer options nested to 0/1 numbered options. Alertness of geriatric depression is characterized when the overall score reaches 5 points or below it. The overall score is calculated a posteriori due to variations on questions directions (e.g., YES = 1 or YES = 0 conditioned to the question). | Change from baseline to 24 weeks |
| Endothelial function, early adaptation | Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography | Change from baseline to 12 weeks |
| Endothelial function | Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography | Change from baseline to 24 weeks |
| Intima-media thickness | Intima-media thickness (IMT) assessed through high resolution ultrasonography | Change from baseline to 24 weeks |
| Body composition | Body composition assessed by dual x-ray absorptiometry system (DXA) | Change from baseline to 24 weeks |
| Quality of life (QoL) | Patients' quality of life will be assessed by the World Health Organization Quality of Life for Elderlies (WHOQoL-OLD) instrument. It comprises 24 questions and answers are presented in a one-way direction, 1-to-5 scale. | Change from baseline to 24 weeks |
| Muscle thickness | Muscle thickness assessed through high resolution ultrasonography | Change from baseline to 24 weeks |
| Muscle quality | Image echo-intensity assessed through high resolution ultrasonography | Change from baseline to 24 weeks |
| Lower body maximal muscle strength | Lower body maximal muscle strength will be assessed by the knee extension one-maximal repetition test, reported in kilograms (kg). | Change from baseline to 24 weeks |