NCT05362071: RED

Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes

Completed NA Last updated 21 September 2023

What this trial tests

NA trial testing Remote Exercise Group in Diabetes Mellitus, Type 2 in 33 participants. Completed in 15 September 2023.

Timeline

2 May 2022

Primary endpoint
14 August 2023

15 September 2023

Quick facts

Lead sponsor	Federal University of Pelotas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	33
Start date	2 May 2022
Primary completion	14 August 2023
Estimated completion	15 September 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Remote Exercise Group
• Group control

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Federal University of Pelotas

Who can join

45 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Rodrigues SN, Delevatti RS, Carvalho MTX, Bullo V, et al · · 2023 · cited 1× · PMID 37858161 · DOI 10.1186/s13063-023-07704-3
2. Cardiometabolic, Functional, and Psychosocial Effects of a Remotely Supervised Home- based Exercise Program in Individuals with Type 2 Diabetes (RED Study): A Randomized Clinical Trial
   Rodrigues SN, Delevatti RS, Carvalho MTX, Alberton CL. · · 2023 · DOI 10.21203/rs.3.rs-2508193/v1