We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03423108
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : February 6, 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 comparing two different combined exercise training doses (300min/week vs 150min/week) against usual care. The study length will last 24 weeks, with assessments conducted at baseline, previously to the group allocation, at 12 weeks and after interventions. Primary outcome is glycated hemoglobin level at 24 weeks. There is also secondary outcomes of clinical importance for the studied population.

Condition or disease Intervention/treatment
Type2 Diabetes Behavioral: G150 Behavioral: G300

Detailed Description:

This is a randomized controlled trial, three-arm, parallel-group, of superiority hypothesis, that aims to evaluate the efficacy of supervised and structured combined exercise training program on HbA1c levels and secondary outcomes in elderly patients with type 2 diabetes. The sample is composed by 132 older adults, divided into three experimental groups. Randomization ratio will be 1:1, resulting in 44 patients per group, and interventions will last 24 weeks. The interventions are composed by a structured a supervised combined exercise training program, three times a week, where the G150 group will perform 150 min/week of aerobic and strength training (50 min per session, 25 min for each modality) and the G300 will perform twice the dose (100 min per session, 50 min for each modality), lasting 24 weeks. There will be a planned progression on training load according to the maximal heart rate percentage for aerobic training; and maximal repetitions, for strength training.

We calculated the sample considering a between-group mean difference of 0.45%, with standard deviation of 0.7% on HbA1c levels, for an 80% power and 5% of type 1 error.

The primary outcome is HbA1c level at 24 weeks, an secondary outcomes are office blood pressure, lipid profile, endothelial function, intima-media thickness, physical fitness, body composition, quality of life and geriatric depressive symptoms. Our study hypothesis is that the G300 will present better improvement in the 24-week HbA1c level as well as in all secondary outcomes. The present study was designed and will be conducted by a multidisciplinary staff and follows ethical and methodological recommendations for clinical trials. We expect to provide evidence for the non-pharmacological treatment of type 2 diabetes in the elderly.


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.
Anticipated Study Start Date : March 1, 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


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: Change from baseline to 12 weeks ]
    Glycated hemoglobin

  2. Office Blood Pressure [ Time Frame: Change from baseline to 12 and 24 weeks ]
    Systolic and diastolic blood pressure measured through automatic oscillometric device

  3. 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

  4. Cardiorespiratory fitness [ Time Frame: Change from baseline to 24 weeks ]
    Peak oxygen uptake (VO2peak) as assessed by maximal cardiopulmonary exercise testing

  5. Geriatric Depression Symptoms [ Time Frame: Change from baseline to 24 weeks ]
    15-item depression symptoms scale (GDS-15)

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

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

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

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

  10. Quality of life (QoL) [ Time Frame: Change from baseline to 24 weeks ]
    World Health Organization Quality of Life questionnaire

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

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

  13. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 defibrillator) or cardiovascular event (non-fatal myocardial infarction, coronary artery bypass surgery, cardiac catheterization, deep vein thrombosis, hospitalization or other severe health-related event) 1 year previously to the enrollment;
  • Severe macular injury (retinopathy) that unable patient to enroll exercise program;
  • Renal disease needing dialysis;
  • Severe cognitive impairment (dementia);
  • Deafness;
  • Blindness;
  • Progressive neurological disorders (Parkinson, multiple sclerosis, etc.);
  • 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: February 6, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD data sharing plan: we will share individual participant data after the clinical trial conclusion. The data will be under the auspicious of the study's PI, but no screening of intenders during the data request act is planned. We will share all the de-identified HbA1c data and relevant supportive information (e.g., sociodemographic, clinical history and allocated groups). Details of the study's design and statistical plan can be found at the study's protocol. Other outcomes could be requested in contact with the PI. We will permit data access after all the participant's study end and they will be accessible according to the EDDIE's PI decision. The data, variables' glossary and statistical code will be accessible at a clinical trial management system nested to the EDDIE Study's website (www.ufrgs.br/eddie). Intenders just need to complete an electronic form to ensure the compliance with our data sharing policy.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: We will permit data access after all the participant's study end and they will be accessible according to the EDDIE's PI decision.
Access Criteria: The data will be under the auspicious of the study's PI, but no screening of intenders during the data request act is planned.
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