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Exercise Dose-response for Diabetes in the Elderly (EDDIE)

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ClinicalTrials.gov Identifier: NCT03423108
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: G150 Behavioral: G300 Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Dose-response for Diabetes in the Elderly: a Randomized Clinical Trial.
Estimated Study Start Date : April 30, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Usual care
Participants randomized to this group will continue their usual care practices, without being intervened by the study.
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).
Behavioral: G150
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).
Behavioral: G300
This group will receive 300 min/week of combined exercise training, structured and supervised.



Primary Outcome Measures :
  1. HbA1c [ Time Frame: Change from baseline to 24 weeks ]
    Glycated hemoglobin in DCCT units (%)


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: Change from baseline to 12 weeks ]
    Glycated hemoglobin in DCCT units (%)

  2. Office Blood Pressure [ Time Frame: Change from baseline to 12 weeks ]
    Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg

  3. Office Blood Pressure [ Time Frame: Change from baseline to 24 weeks ]
    Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg

  4. 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)

  5. 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)

  6. 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).

  7. Endothelial function, early adaptation [ Time Frame: Change from baseline to 12 weeks ]
    Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography

  8. Endothelial function [ Time Frame: Change from baseline to 24 weeks ]
    Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography

  9. Intima-media thickness [ Time Frame: Change from baseline to 24 weeks ]
    Intima-media thickness (IMT) assessed through high resolution ultrasonography

  10. Body composition [ Time Frame: Change from baseline to 24 weeks ]
    Body composition assessed by dual x-ray absorptiometry system (DXA)

  11. 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.

  12. Muscle thickness [ Time Frame: Change from baseline to 24 weeks ]
    Muscle thickness assessed through high resolution ultrasonography

  13. Muscle quality [ Time Frame: Change from baseline to 24 weeks ]
    Image echo-intensity assessed through high resolution ultrasonography

  14. 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).



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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

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


Contacts
Contact: Lucas Helal, MSc +55 51 3359-6332 lhelal@hcpa.edu.br
Contact: Cintia Botton, PhD +55 51 3359-6332 cbotton@hcpa.edu.br

Locations
Brazil
Hospital de Clinicas de Porto Alegre Not yet recruiting
Pôrto Alegre, Rio Grande Do Sul, Brazil
Contact: Lucas Helal, MSc    +55 51 3359-6332    lhelal@hcpa.edu.br   
Contact: Cintia Botton, PhD    +55 51 3359-6332    cbotton@hcpa.edu.br   
Principal Investigator: Daniel Umpierre, PhD         
Sub-Investigator: Beatriz D'Agord Schaan, MD, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
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

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03423108     History of Changes
Other Study ID Numbers: 17-0303
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data after will be shared after trial completion. Data usage will be under the PI's auspices, but restrictions or screenings will not be imposed upon data requests. ABPM data 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: The individual participant dataset will become available up to six months after the first study publication.
Access Criteria: A simple registration aside a policy acceptance term will grant access to study's datasets.
URL: http://www.ufrgs.br/eddie

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Exercise
Aging
Elderly
Physical Activity
Cardiovascular Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases