Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05362071
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2022-04-06
Brief Title:
Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes
Sponsor:
Federal University of Pelotas
Organization:
Federal University of Pelotas
Study Overview
Official Title:
Cardiometabolic Functional and Psychosocial Effects of a Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RED
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 PelotasRS 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 Borgs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None