Exercise Dose-response for Diabetes in the Elderly

Type2 Diabetes Clinical Trial

— EDDIE  

Official title:

Exercise Dose-response for Diabetes in the Elderly: a Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03423108
• Other study ID #: 17-0303
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: March 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Angélica De Nardi, MSc
• Phone: +55 51 3359-6332
• Email: atnardi[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: August 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type2 Diabetes

Intervention

Behavioral:
• G150
This group will receive 150 min/week of combined exercise training, structured and supervised.
• G300
This group will receive 300 min/week of combined exercise training, structured and supervised.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Glycated hemoglobin in DCCT units (%)	Change from baseline to 24 weeks
Secondary	HbA1c	Glycated hemoglobin in DCCT units (%)	Change from baseline to 12 weeks
Secondary	Office Blood Pressure	Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg	Change from baseline to 12 weeks
Secondary	Office Blood Pressure	Systolic and diastolic blood pressure measured through automatic oscillometric device in mmHg	Change from baseline to 24 weeks
Secondary	Lower limbs functional capacity	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
Secondary	Cardiorespiratory fitness	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
Secondary	Geriatric Depression Symptoms	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).	Change from baseline to 24 weeks
Secondary	Endothelial function, early adaptation	Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography	Change from baseline to 12 weeks
Secondary	Endothelial function	Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography	Change from baseline to 24 weeks
Secondary	Intima-media thickness	Intima-media thickness (IMT) assessed through high resolution ultrasonography	Change from baseline to 24 weeks
Secondary	Body composition	Body composition assessed by dual x-ray absorptiometry system (DXA)	Change from baseline to 24 weeks
Secondary	Quality of life (QoL)	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
Secondary	Muscle thickness	Muscle thickness assessed through high resolution ultrasonography	Change from baseline to 24 weeks
Secondary	Muscle quality	Image echo-intensity assessed through high resolution ultrasonography	Change from baseline to 24 weeks
Secondary	Lower body maximal muscle strength	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