Clinical trial NCT05362071: Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes
Official title: Cardiometabolic, Functional and Psychosocial Effects of a Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Exercise
Remote exercise
Glicemic control
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 33
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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%.


Eligibility criteria: 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

Primary outcomes:
measure: Glycaemic control
timeFrame: Baseline (week 0) to Post-training (week 13)
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Diastolic blood pressure
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Capillary blood glucose
timeFrame: 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).
measure: Lower limb strength
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Upper limb strength
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Agility and dynamic balance
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Aerobic capacity
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Flexibility
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Quality of life (QOL) will be verified using the EUROHIS-QOL 8-item index
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Sleep quality will be verified using the Pittsburgh Sleep Quality Index Self-report Questionnaire
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Depressive symptoms
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Emotional stress related to diabetes
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Physical activity levels
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Eating habits
timeFrame: Baseline (week 0) to Post-training (week 13)
measure: Subjective perception of well-being
timeFrame: Post-training (week 13)
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas, Pelotas, Brazil
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Pelotas
name: Cristine L Alberton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Santa Catarina
name: Rodrigo S Delevatti, PhD
role: STUDY_DIRECTOR
References: