Cardiometabolic, Functional and Psychosocial Effects of a Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Glycaemic control
研究概览
简要总结
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Remote Exercise Group
Participants will practice physical exercises twice a week, remotely and under the supervision of an exercise professional, for 12 weeks.
干预措施: Remote Exercise Group (Other)
Group control
Participants will receive a booklet with recommendations for physical activity from the physical activity guide for the Brazilian population.
干预措施: Group control (Other)
结局指标
主要结局
Glycaemic control
时间窗: Baseline (week 0) to Post-training (week 13)
Blood samples will be collected to be later performed a laboratory analysis regarding the HbA1c levels of each of the participants.
次要结局
- 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).)
- Upper limb strength(Baseline (week 0) to Post-training (week 13))
- Quality of life (QOL) will be verified using the EUROHIS-QOL 8-item index(Baseline (week 0) to Post-training (week 13))
- Depressive symptoms(Baseline (week 0) to Post-training (week 13))
- Eating habits(Baseline (week 0) to Post-training (week 13))
- Systolic blood pressure(Baseline (week 0) to Post-training (week 13))
- Agility and dynamic balance(Baseline (week 0) to Post-training (week 13))
- Flexibility(Baseline (week 0) to Post-training (week 13))
- Sleep quality will be verified using the Pittsburgh Sleep Quality Index Self-report Questionnaire(Baseline (week 0) to Post-training (week 13))
- Physical activity levels(Baseline (week 0) to Post-training (week 13))
- Lower limb strength(Baseline (week 0) to Post-training (week 13))
- Aerobic capacity(Baseline (week 0) to Post-training (week 13))
- Subjective perception of well-being(Post-training (week 13))
- Emotional stress related to diabetes(Baseline (week 0) to Post-training (week 13))
研究者
Cristine Lima Alberton
Principal investigator
Federal University of Pelotas