Exercise Dose-response for Diabetes in the Elderly (EDDIE)
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|ClinicalTrials.gov Identifier: NCT03423108|
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes||Behavioral: G150 Behavioral: G300||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Exercise Dose-response for Diabetes in the Elderly: a Randomized Clinical Trial.|
|Estimated Study Start Date :||September 10, 2018|
|Estimated Primary Completion Date :||January 1, 2019|
|Estimated Study Completion Date :||August 1, 2020|
No Intervention: Control
Participants randomized to this group will perform monthly cohabitation meetings.
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).
This group will receive 150 min/week of combined exercise training, structured and supervised.
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).
This group will receive 300 min/week of combined exercise training, structured and supervised.
- HbA1c [ Time Frame: Change from baseline to 24 weeks ]Glycated hemoglobin in DCCT units (%)
- HbA1c [ Time Frame: Change from baseline to 12 weeks ]Glycated hemoglobin in DCCT units (%)
- Office Blood Pressure [ Time Frame: Change from baseline to 12 weeks ]Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg
- Office Blood Pressure [ Time Frame: Change from baseline to 24 weeks ]Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg
- Lower limbs functional capacity [ Time Frame: Change from baseline to 24 weeks ]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)
- Cardiorespiratory fitness [ Time Frame: Change from baseline to 24 weeks ]Peak oxygen uptake (VO2peak) assessed by maximal cardiopulmonary exercise testing and reported in its weighted form (ml/kg/min)
- Geriatric Depression Symptoms [ Time Frame: Change from baseline to 24 weeks ]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).
- Endothelial function, early adaptation [ Time Frame: Change from baseline to 12 weeks ]Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
- Endothelial function [ Time Frame: Change from baseline to 24 weeks ]Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
- Intima-media thickness [ Time Frame: Change from baseline to 24 weeks ]Intima-media thickness (IMT) assessed through high resolution ultrasonography
- Body composition [ Time Frame: Change from baseline to 24 weeks ]Body composition assessed by dual x-ray absorptiometry system (DXA)
- Quality of life (QoL) [ Time Frame: Change from baseline to 24 weeks ]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.
- Muscle thickness [ Time Frame: Change from baseline to 24 weeks ]Muscle thickness assessed through high resolution ultrasonography
- Muscle quality [ Time Frame: Change from baseline to 24 weeks ]Image echo-intensity assessed through high resolution ultrasonography
- Lower body maximal muscle strength [ Time Frame: Change from baseline to 24 weeks ]Lower body maximal muscle strength will be assessed by the knee extension one-maximal repetition test, reported in kilograms (kg).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423108
|Contact: Angélica De Nardi, MSc||+55 51 firstname.lastname@example.org|
|Contact: Lucinéia Pfeifer, MSc||+55 51 email@example.com|
|Hospital de Clinicas de Porto Alegre||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil|
|Contact: Angélica De Nardi, MSc +55 51 3359-6332 firstname.lastname@example.org|
|Contact: Lucinéia Pfeifer, MSc +55 51 3359-6332 email@example.com|
|Principal Investigator: Daniel Umpierre, PhD|
|Sub-Investigator: Beatriz D'Agord Schaan, MD, PhD|
|Principal Investigator:||Daniel Umpierre, PhD||Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul|
|Study Director:||Beatriz Schaan, MD, PhD||Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul|