Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes (RED)

Federal University of Pelotas

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Remote Exercise Group; Other: Group control

Study type: Interventional

Funder types: Other

Identifiers

NCT05362071

55791622.8.0000.5313

Details and patient eligibility

About

The present study, characterized as a randomized clinical trial, aims to verify the effects of a remotely supervised exercise program, compared to a control group, on cardiometabolic, functional, and psychosocial outcomes in individuals with type 2 diabetes (DMT2). Males and females with T2DM from the city of Pelotas/RS who meet the study eligibility criteria will participate in the study. Participants will be randomized into the intervention group (IG) and control group (CG). The IG will perform a 12-week exercise program supervised remotely via video call, while GC will receive recommendations for physical activity. Participants will be evaluated at baseline (week 0) and after intervention (week 13). Initially, data for sample characterization, blood pressure, capillary blood glucose, and functional tests will collect during a home visit. In a second moment, participants will be invited to go to a specific laboratory for collecting glycated hemoglobin (HbA1c). Subsequently, a third date will be scheduled to apply self-administered questionnaires (online via GoogleDocs) related to the quality of life, sleep quality, depressive symptoms, emotional stress related to diabetes, level of physical activity, and eating habits. Additionally, acute glycemic responses will be evaluated before and immediately after an exercise session three times throughout the intervention. Capillary blood glucose will be collected in sessions performed in the initial period of mesocycles 1, 2, and 4. At week 13, reassessment will be realized by the same baseline assessors. Over the 12 weeks, a combined training will be carried out with remote supervision. Participants will perform strength exercises at usual and maximum execution speed and aerobic exercises at a rating of perceived effort between 11 and 15 on Borg's scale. The sessions will have a total duration between 37 and 57 min and a weekly frequency of two weekly sessions in the first six weeks and three weekly sessions in the remaining six weeks. Data will be expressed as mean and standard deviation. Data analysis between pre-and post-intervention moments, as well as between groups, will be performed by Generalized Estimated Equations, with Bonferroni post hoc, considering both per-protocol (including participants who meet 70% of frequency in the intervention) and intention to treat analysis (including all randomized participants), assuming an alpha level of 5%.

Enrollment: 33 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being under medical treatment using oral hypoglycemic agents
• Female and male patients with type 2 diabetes;
• Not be involved with physical exercises in the last three months;
• Being semi-literate.

Exclusion criteria

• Make use of insulin;
• History of cardiovascular disease (except drug-controlled high blood pressure);
• Presence of severe autonomic neuropathy, painful peripheral neuropathy or history of foot injuries, proliferative diabetic retinopathy, severe non-proliferative diabetic retinopathy;
• Muscle or joint impairment that precludes performing physical exercises safely
• Lack of internet access

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Remote Exercise Group

Experimental group

Description:

Participants will practice physical exercises twice a week, remotely and under the supervision of an exercise professional, for 12 weeks.

Treatment:

Other: Remote Exercise Group

Group control

Other group

Description:

Participants will receive a booklet with recommendations for physical activity from the physical activity guide for the Brazilian population.

Treatment:

Other: Group control