Exercise Dose-response for Diabetes in the Elderly

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03423108
• Date of registration: 31/01/2018
• Prospective Registration: Yes
• Primary sponsor: Hospital de Clinicas de Porto Alegre
• Public title: Exercise Dose-response for Diabetes in the Elderly EDDIE
• Scientific title: Exercise Dose-response for Diabetes in the Elderly: a Randomized Clinical Trial.
• Date of first enrolment: September 10, 2018
• Target sample size: 132
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03423108
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Daniel Umpierre, PhD
• Affiliation: Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul

• Name: Angélica De Nardi, MSc

• Name: Angélica De Nardi, MSc

• Name: Beatriz Schaan, MD, PhD
• Affiliation: Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul

Key inclusion & exclusion 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;

- 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.



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type2 Diabetes

Intervention(s)

Behavioral: G300

Behavioral: G150

Primary Outcome(s)

HbA1c [Time Frame: Change from baseline to 24 weeks]

Secondary Outcome(s)

Cardiorespiratory fitness [Time Frame: Change from baseline to 24 weeks]

Endothelial function [Time Frame: Change from baseline to 24 weeks]

Office Blood Pressure [Time Frame: Change from baseline to 12 weeks]

Body composition [Time Frame: Change from baseline to 24 weeks]

Lower body maximal muscle strength [Time Frame: Change from baseline to 24 weeks]

Geriatric Depression Symptoms [Time Frame: Change from baseline to 24 weeks]

HbA1c [Time Frame: Change from baseline to 12 weeks]

Intima-media thickness [Time Frame: Change from baseline to 24 weeks]

Lower limbs functional capacity [Time Frame: Change from baseline to 24 weeks]

Muscle thickness [Time Frame: Change from baseline to 24 weeks]

Muscle quality [Time Frame: Change from baseline to 24 weeks]

Quality of life (QoL) [Time Frame: Change from baseline to 24 weeks]

Endothelial function, early adaptation [Time Frame: Change from baseline to 12 weeks]

Office Blood Pressure [Time Frame: Change from baseline to 24 weeks]

Secondary ID(s)

17-0303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Federal University of Rio Grande do Sul