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

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ClinicalTrials.gov Identifier: NCT03423108
Recruitment Status : Unknown
Verified March 2018 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : February 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date September 6, 2018
Estimated Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
HbA1c [ Time Frame: Change from baseline to 24 weeks ]
Glycated hemoglobin in DCCT units (%)
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
HbA1c [ Time Frame: Change from baseline to 24 weeks ]
Glycated hemoglobin
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • HbA1c [ Time Frame: Change from baseline to 12 weeks ]
    Glycated hemoglobin
  • Office Blood Pressure [ Time Frame: Change from baseline to 12 and 24 weeks ]
    Systolic and diastolic blood pressure measured through automatic oscillometric device
  • 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
  • Cardiorespiratory fitness [ Time Frame: Change from baseline to 24 weeks ]
    Peak oxygen uptake (VO2peak) as assessed by maximal cardiopulmonary exercise testing
  • Geriatric Depression Symptoms [ Time Frame: Change from baseline to 24 weeks ]
    15-item depression symptoms scale (GDS-15)
  • 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 ]
    World Health Organization Quality of Life questionnaire
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Dose-response for Diabetes in the Elderly
Official Title  ICMJE Exercise Dose-response for Diabetes in the Elderly: a Randomized Clinical Trial.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE
  • Behavioral: G150
    This group will receive 150 min/week of combined exercise training, structured and supervised.
  • Behavioral: G300
    This group will receive 300 min/week of combined exercise training, structured and supervised.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: G150
  • 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).
    Intervention: Behavioral: G300
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 31, 2018)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03423108
Other Study ID Numbers  ICMJE 17-0303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Federal University of Rio Grande do Sul
Investigators  ICMJE
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
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP