Exercise Dose-response for Diabetes in the Elderly

NCT03423108 | Unknown DMC

• 1 other identifier: 17-0303
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

Exercise; Aging; Elderly; Physical Activity; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Glycated hemoglobin in DCCT units (%)

  Change from baseline to 24 weeks

Secondary Outcomes (14)

• HbA1c

  Change from baseline to 12 weeks

• Office Blood Pressure

  Change from baseline to 12 weeks

• Office Blood Pressure

  Change from baseline to 24 weeks

• Lower limbs functional capacity

  Change from baseline to 24 weeks

• Cardiorespiratory fitness

  Change from baseline to 24 weeks

Study Arms (3)

Control

NO INTERVENTION

Participants randomized to this group will perform monthly cohabitation meetings.

G150

EXPERIMENTAL

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

G300

EXPERIMENTAL

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

Interventions

G150 BEHAVIORAL

This group will receive 150 min/week of combined exercise training, structured and supervised.

G150

G300 BEHAVIORAL

This group will receive 300 min/week of combined exercise training, structured and supervised.

G300

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Daniel Umpierre, PhD

  Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Beatriz Schaan, MD, PhD

  Hospital de Clinicas de Porto Alegre/Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Central Study Contacts

Angélica De Nardi, MSc

CONTACT

+55 51 3359-6332; atnardi@hcpa.edu.br

Lucinéia Pfeifer, MSc

CONTACT

+55 51 3359-6332; lpfeifer@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: September 10, 2018
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2020
• Last Updated: September 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

BR (1)