Exercise Dose-response for Diabetes in the Elderly

NCT ID: NCT03423108

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2020-08-01

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Participants randomized to this group will perform monthly cohabitation meetings.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

G150

Intervention Type: BEHAVIORAL

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

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).

Group Type: EXPERIMENTAL

G300

Intervention Type: BEHAVIORAL

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

Interventions

G150

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

Intervention Type: BEHAVIORAL

G300

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Umpierre, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Beatriz Schaan, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Angélica De Nardi, MSc

Role: CONTACT

atnardi@hcpa.edu.br

+55 51 3359-6332

Lucinéia Pfeifer, MSc

Role: CONTACT

lpfeifer@hcpa.edu.br

+55 51 3359-6332

Facility Contacts

Angélica De Nardi, MSc

Role: primary

atnardi@hcpa.edu.br

+55 51 3359-6332

Lucinéia Pfeifer, MSc

Role: backup

lpfeifer@hcpa.edu.br

+55 51 3359-6332

Other Identifiers

17-0303

Identifier Type: -

Identifier Source: org_study_id