Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2023-09-15

Brief Summary

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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%.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, single-blinded, parallel, superiority, controlled trial. Participants males and females with type 2 diabetes mellitus will be allocated to experimental and control groups based on a randomization sequence created in blocks by an independent research assistant with a 1:1 ratio. Allocation concealment will be implemented through a central randomization routine conducted by the same investigator to generate the sequence. The allocation of participants will occur after the completion of baseline outcomes evaluations.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Masking Description: Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded.

Study Groups

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Remote Exercise Group

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

Group Type EXPERIMENTAL

Remote Exercise Group

Intervention Type OTHER

The intervention will have a weekly frequency of two sessions on non-consecutive days during the first six weeks and three sessions on non-consecutive days for the remaining six weeks. The exercise intervention will consist of four 3-week mesocycles. The session's structure will consist of a warm-up, the main part, in which a combined training program will be carried out, consisting of three distinct blocks, and at the end, stretching. Blocks 1 and 2 will consist of three strength exercises with bodyweight and alternative materials and aerobic training. Between blocks 1 and 2, and later in block 3, participants will take a free walk with displacement in the space they have available in their own home. The session will end with stretching exercises for the main muscle groups. The sessions will last 37 to 57 minutes over 12 weeks, with approximately 5 min of warm-up and stretching, and the main part ranging from 27 min to 47 min throughout the intervention.

Group control

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

Group Type OTHER

Group control

Intervention Type OTHER

Participants allocated to the GC will receive recommendations for the practice of physical activity based on information from three specific chapters of the Physical Activity Guide for the Brazilian Population (2021). The GC will receive through Whatsapp the information that is available in chapters 1, 4, and 5, which address the following topics: "Understanding Physical Activity," "Physical Activity for Adults," and "Physical Activity for the Elderly." If sending via Whatsapp is not possible, the booklet will be printed and delivered to the participant. At the end of the 12 weeks, the same booklet will be made available to IG participants.

Interventions

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Remote Exercise Group

The intervention will have a weekly frequency of two sessions on non-consecutive days during the first six weeks and three sessions on non-consecutive days for the remaining six weeks. The exercise intervention will consist of four 3-week mesocycles. The session's structure will consist of a warm-up, the main part, in which a combined training program will be carried out, consisting of three distinct blocks, and at the end, stretching. Blocks 1 and 2 will consist of three strength exercises with bodyweight and alternative materials and aerobic training. Between blocks 1 and 2, and later in block 3, participants will take a free walk with displacement in the space they have available in their own home. The session will end with stretching exercises for the main muscle groups. The sessions will last 37 to 57 minutes over 12 weeks, with approximately 5 min of warm-up and stretching, and the main part ranging from 27 min to 47 min throughout the intervention.

Intervention Type OTHER

Group control

Participants allocated to the GC will receive recommendations for the practice of physical activity based on information from three specific chapters of the Physical Activity Guide for the Brazilian Population (2021). The GC will receive through Whatsapp the information that is available in chapters 1, 4, and 5, which address the following topics: "Understanding Physical Activity," "Physical Activity for Adults," and "Physical Activity for the Elderly." If sending via Whatsapp is not possible, the booklet will be printed and delivered to the participant. At the end of the 12 weeks, the same booklet will be made available to IG participants.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No