Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes

NCT05362071 | Completed

• 1 other identifier: 55791622.8.0000.5313
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes; Exercise; Remote exercise; Glicemic control

Outcome Measures

Primary Outcomes (1)

• Glycaemic control

  Blood samples will be collected to be later performed a laboratory analysis regarding the HbA1c levels of each of the participants.

  Baseline (week 0) to Post-training (week 13)

Secondary Outcomes (15)

• Systolic blood pressure

  Baseline (week 0) to Post-training (week 13)

• Diastolic blood pressure

  Baseline (week 0) to Post-training (week 13)

• Capillary blood glucose

  Baseline (week 0) to Post-training (week 13), and pre and immediately after an exercise session performed in the initial period of mesocycles 1, 2 and 4, in the IG participants (each mesocycle consists of 3 weeks).

• Lower limb strength

  Baseline (week 0) to Post-training (week 13)

• Upper limb strength

  Baseline (week 0) to Post-training (week 13)

Study Arms (2)

Remote Exercise Group

EXPERIMENTAL

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

Other: Remote Exercise Group

Group control

OTHER

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

Other: Group control

Interventions

Remote Exercise Group 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.

Remote Exercise Group

Group control 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.

Group control

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas, Pelotas, Brazil

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Publications (1)

• Rodrigues SN, Delevatti RS, Carvalho MTX, Bullo V, Bergamin M, Alberton CL. Cardiometabolic, functional, and psychosocial effects of a remotely supervised home-based exercise program in individuals with type 2 diabetes (RED study): study protocol for a randomized clinical trial. Trials. 2023 Oct 19;24(1):679. doi: 10.1186/s13063-023-07704-3.

  PMID: 37858161 DERIVED

Related Links

• Psychometric properties of the EUROHIS-QOL 8-item index (WHOQOL-8) in a Brazilian sample
• Validation of the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index
• Sensitivity and specificity of the Patient Health Questionnaire-9 (PHQ-9) among adults from the general population
• Brazilian version of the Problem Areas in Diabetes Scale (B-PAID): validation and identification of individuals at high risk for emotional distress
• QUESTIONÁRIO INTERNACIONAL DE ATIVIDADE FÍSICA (IPAQ): ESTUDO DE VALIDADE E REPRODUTIBILIDADE NO BRASIL
• Effectiveness of a Behavior Change Program on Physical Activity and Eating Habits in Patients With Hypertension: A Randomized Controlled Trial
• Development and validation of a functional fitness test for a community-residing adults
• The timed "Up \& Go": a test of basic functional mobility for frail elderly persons

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Cristine L Alberton, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

• Rodrigo S Delevatti, PhD

  Federal University of Santa Catarina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 5, 2022
• Study Start: May 2, 2022
• Primary Completion: August 14, 2023
• Study Completion: September 15, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)