- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03423108
Exercise Dose-response for Diabetes in the Elderly (EDDIE)
Exercise Dose-response for Diabetes in the Elderly: a Randomized Clinical Trial.
Study Overview
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angélica De Nardi, MSc
- Phone Number: +55 51 3359-6332
- Email: atnardi@hcpa.edu.br
Study Contact Backup
- Name: Lucinéia Pfeifer, MSc
- Phone Number: +55 51 3359-6332
- Email: lpfeifer@hcpa.edu.br
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil
- Recruiting
- Hospital de Clinicas de Porto Alegre
-
Contact:
- Angélica De Nardi, MSc
- Phone Number: +55 51 3359-6332
- Email: atnardi@hcpa.edu.br
-
Contact:
- Lucinéia Pfeifer, MSc
- Phone Number: +55 51 3359-6332
- Email: lpfeifer@hcpa.edu.br
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Principal Investigator:
- Daniel Umpierre, PhD
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Sub-Investigator:
- Beatriz D'Agord Schaan, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Previous diagnosis of type 2 diabetes mellitus by HbA1c (> 6.5%) or capillary casual glycemia (> 126 mg/dL), oral glucose tolerance test or hypoglycemic drug use;
- HbA1c ≥ 7.5%;
- Verified ability to exercise;
- Physically inactive or regularly exercising for at least once a week.
Exclusion Criteria:
- HbA1c ≤ 12%;
- Severe cardiovascular disease (class III or IV heart failure, uncontrolled arrhythmia, unstable angina, or use of implantable cardioverter defibrillator);
- Major cardiovascular events 1 year previously to the enrollment (non-fatal myocardial infarction, coronary artery bypass surgery, cardiac catheterization, deep vein thrombosis, hospitalization or other severe health-related event);
- Chronic renal disease requesting dialysis;
- Severe macular injury (retinopathy) that disables patients to enroll an exercise program;
- Severe cognitive impairment (dementia) that disables patients to enroll an exercise program;
- Deafness that disables patients to enroll an exercise program;
- Blindness that disables patients to enroll an exercise program;
- Progressive neurological disorders (Parkinson, multiple sclerosis, etc.) that disables patients to enroll an exercise program;
- Osteoarticular or muscular injuries or another health conditions which generate inability to carry on the interventions;
- Plans of moving to another city during the study;
- Living together with another person enrolled in the study;
- A medical report indicating exercise contraindication based on a cardiopulmonary exercise testing;
- Inability or refusal to give written consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Participants randomized to this group will perform monthly cohabitation meetings.
|
|
Experimental: G150
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.
|
Experimental: G300
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Change from baseline to 24 weeks
|
Glycated hemoglobin in DCCT units (%)
|
Change from baseline to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Change from baseline to 12 weeks
|
Glycated hemoglobin in DCCT units (%)
|
Change from baseline to 12 weeks
|
Office Blood Pressure
Time Frame: Change from baseline to 12 weeks
|
Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg
|
Change from baseline to 12 weeks
|
Office Blood Pressure
Time Frame: Change from baseline to 24 weeks
|
Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg
|
Change from baseline to 24 weeks
|
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)
|
Change from baseline to 24 weeks
|
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)
|
Change from baseline to 24 weeks
|
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).
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Change from baseline to 24 weeks
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Endothelial function, early adaptation
Time Frame: Change from baseline to 12 weeks
|
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
|
Change from baseline to 12 weeks
|
Endothelial function
Time Frame: Change from baseline to 24 weeks
|
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
|
Change from baseline to 24 weeks
|
Intima-media thickness
Time Frame: Change from baseline to 24 weeks
|
Intima-media thickness (IMT) assessed through high resolution ultrasonography
|
Change from baseline to 24 weeks
|
Body composition
Time Frame: Change from baseline to 24 weeks
|
Body composition assessed by dual x-ray absorptiometry system (DXA)
|
Change from baseline to 24 weeks
|
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.
|
Change from baseline to 24 weeks
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Muscle thickness
Time Frame: Change from baseline to 24 weeks
|
Muscle thickness assessed through high resolution ultrasonography
|
Change from baseline to 24 weeks
|
Muscle quality
Time Frame: Change from baseline to 24 weeks
|
Image echo-intensity assessed through high resolution ultrasonography
|
Change from baseline to 24 weeks
|
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).
|
Change from baseline to 24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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