Effect of Low-intensity Aerobic Regular Activity on Heart Rate Variability in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Heart Rate Variability (HRV) parameters.
研究概览
简要总结
A monocentric prospective randomized trial included 35 patients with Type 1 diabetes. Participants were randomized into two groups: Group A with the patients who engaged in low-intensity physical activity matching aerobic threshold five days per week over a one-year observation period and Group B with the patients who engaged in physical activity less than five days per week. The study included three clinical visits: at baseline, at six months, and at one year. Assessments included cardiopulmonary exercise testing (CPET) and body composition analysis during the baseline visit and at six-month visit, while 24-hour Holter monitoring was conducted at baseline and at the final visit. Biochemical parameters and microvascular complication risk assessments were performed at every visit.
详细描述
The ELARA-T1D study aims to investigate the impact of regular, long-standing low-intensity aerobic physical activity on heart rate variability (HRV) and cardiovascular autonomic neuropathy (CAN) in patients with Type 1 Diabetes Mellitus (T1DM). While physical activity is a cornerstone of diabetes management, fear of hypoglycemia and lack of specific guidelines often prevent patients from engaging in exercise. The mechanisms by which physical activity improves cardiovascular outcomes are not yet fully understood. Intensity matching threshold has been linked to longevity and mitochondrial efficiency, while enhancing capillary density and mitochondrial quality. This study focuses on reducing cardiovascular risk in T1DM through an unstructured low-intensity physical activity five days per week for 30-60 min per exercise, per exercise, performed at the intensity matching aerobic threshold.
This is a randomized, parallel-assignment longitudinal study. Following a screening phase (0-4 months) to verify inclusion/exclusion criteria and baseline laboratory status, eligible participants had been randomized into two groups:
Experimental Group (Group A): Introduction of low-intensity aerobic activity five days per week for 30-60 minutes. The intensity is individually determined via cardiopulmonary exercise testing (CPET) to achieve training zone 2.
Control Group (Group B): Maintenance of low-activity lifestyle (not exceeding 30 minutes, less than five days per week).
The physical activity protocol is monitored using heart rate tracking (Garmin watches) to ensure patients stay within the prescribed intensity zones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 1Diabetes at least six months prior to study enrollment
- •Male or female patients over 18 years
- •Willingness to perform physical activity 5 days/week.
- •Absence of heavy, chronic microvascular complications.
- •Absence of established Cardiovascular neuropathy.
- •Absence of established ASCVD.
排除标准
- •Type 2 Diabetes
- •Active engagement in professional sports
- •Limb amputation
- •Blindness
- •Active malignancy
研究组 & 干预措施
Experimental group
The exercise group will consist of patients with type 1 diabetes who will perform low-intensity physical activity in the postprandial period five days per week over a one-year observation period.
干预措施: low-intensity physical activity (Behavioral)
Experimental group
The exercise group will consist of patients with type 1 diabetes who will perform low-intensity physical activity in the postprandial period five days per week over a one-year observation period.
干预措施: Intensive insulin therapy (Other)
Control group
Type 1 diabetes patients characterized by a sedentary lifestyle, defined as engaging in low-intensity physical activity less than five days per week.
干预措施: Intensive insulin therapy (Other)
结局指标
主要结局
Change in Heart Rate Variability (HRV) parameters.
时间窗: Twelve months from the baseline.
Assessment of HRV as a marker for Cardiovascular Autonomic Neuropathy (CAN). The measurement tool is a 24-hour Holter ECG monitor. Specific parameters include the Standard Deviation of NN intervals (SDNN) and Root Mean Square of Successive Differences (RMSSD). Unit of Measure: Milliseconds (ms).
次要结局
- Change in Peak Oxygen Consumption (VO2 peak)(Six months from the baseline.)
- Change in Time in Range (TIR).(Six and twelve months from the baseline.)
- Change in Urine Albumin-to-Creatinine Ratio (UACR).(Six months from the baseline.)