Application of Blood Flow Restriction Training in the Exercise Intervention of Chronic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (HbA1c) at follow-up
研究概览
简要总结
Blood flow restriction training (BFRT) combined with resistance or aerobic exercise has been shown to improve the glucose uptake in humans. In addition, BFRT represents a low-load, alternative exercise program for type 2 diabetes patients who often have reduced physical fitness. However, it is not clear to what extent could BFRT improve glycemic control among patients with type 2 diabetes. This pilot randomized-controlled trial aims to investigate the effect of a 12-week, low-intensity BFRT on glycemic control among patients with type 2 diabetes, compared to medium-high intensity aerobic exercise or low-intensity exercise without BFRT.
详细描述
Objectives:
The pilot randomized study aims to explore the effects of blood flow restriction combined with aerobic training (BFRT) on the glucose and lipid metabolism indexes and vascular endothelial factors of type 2 diabetes, by comparing it with traditional low-intensity and high-intensity aerobic training. It aims to evaluate the effectiveness of BFRT in glycemic control of type 2 diabetes patients.
Study Population:
A total of 60 patients with type 2 diabetes who are 50-65 years old at the Maigaoqiao Community Health Service Center, Qixia District, Nanjing, China, with a course of type 2 diabetes of 2-10 years will be included as the participants.
Randomization:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes patients diagnosed by at least one of these criteria: 1) random blood glucose >= 11.1mmol/L; 2) fasting blood glucose >= 7.0 mmol/L; 3) 2-hr post oral glucose tolerance test blood glucose >= 11.1mmol/L; 4) hemoglobin A1c >= 6.5%.
- •aged between 50-65 years at baseline
- •disease course of type 2 diabetes between at least 1 year
排除标准
- •type 1 diabetes
- •fasting blood glucose > 16.7 mmol/L, or suffers frequent hypoglycemia, or have significant glucose fluctuations considered by the physician
- •body mass index > 33 kg/m2
- •severe diabetes complications, including cardiovascular diseases, cerebrovascular diseases, diabetic retinopathy, kidney diseases, diabetic ketoacidosis, and diabetic foot ulcers
- •neuromuscular disorders, sarcopenia, severe osteoporosis, dementia
- •have regular moderate-intensive exercise habit
- •resting systolic blood pressure >= 160 mmHg or resting diastolic blood pressure >= 100 mmHg
- •abnormal electrocardiogram
- •other comorbidities or medications irrelevant to diabetes treatment that may influence glycemia during the past 6 months
结局指标
主要结局
Hemoglobin A1c (HbA1c) at follow-up
时间窗: At week 13, within 7 days after the completion of the 12-week intervention (observation)
HbA1c level in blood
Fasting glucose at baseline
时间窗: At baseline, within 7 days before the intervention (observation) starts
blood glucose level following overnight (12-h) fasting
Fasting glucose at follow-up
时间窗: At week 13, within 7 days after the completion of the 12-week intervention (observation)
blood glucose level following overnight (12-h) fasting
Fasting insulin at baseline
时间窗: At baseline, within 7 days before the intervention (observation) starts
blood insulin level following overnight (12-h) fasting
Hemoglobin A1c (HbA1c) at baseline
时间窗: At baseline, within 7 days before the intervention (observation) starts
HbA1c level in blood
Fasting insulin at follow-up
时间窗: At week 13, within 7 days after the completion of the 12-week intervention (observation)
blood insulin level following overnight (12-h) fasting
次要结局
- Continuous glucose monitoring(At baseline, within 14 days before the intervention (observation) starts, measurement lasts for 14 days)
- Weight at follow-up(At week 13, within 7 days after the completion of the 12-week intervention (observation))
- non-esterified fatty acid (NEFA) at baseline(At baseline, within 7 days before the intervention (observation) starts)
- Total sleep duration and total awakening duration at baseline(At baseline, within 14 days before the intervention (observation) starts, measurement lasts for at least 7 days)
- Height at baseline(At baseline, within 7 days before the intervention (observation) starts)
- Height at follow-up(At week 13, within 7 days after the completion of the 12-week intervention (observation))
- Weight at baseline(At baseline, within 7 days before the intervention (observation) starts)
- Pittsburg sleep quality index (PSQI) at baseline(At baseline, within 7 days before the intervention (observation) starts)
- Total sleep duration and total awakening duration at follow-up(At week 13, within 14 days after the completion of the 12-week intervention (observation), measurement lasts for at least 7 days)
- IL-6 at follow-up(At week 13, within 7 days after the completion of the 12-week intervention (observation))
- Pittsburg sleep quality index (PSQI) at follow-up(At week 13, within 7 days after the completion of the 12-week intervention (observation))
- total cholesterol at baseline(At baseline, within 7 days before the intervention (observation) starts)
- total cholesterol at follow-up(At week 13, within 7 days after the completion of the 12-week intervention (observation))
- triglyceride at baseline(At baseline, within 7 days before the intervention (observation) starts)
- triglyceride at follow-up(At week 13, within 7 days after the completion of the 12-week intervention (observation))
- non-esterified fatty acid (NEFA) at follow-up(At week 13, within 7 days after the completion of the 12-week intervention (observation))
- International Physical Activity Questionnaire - Short Form at baseline(At week 13, within 7 days after the completion of the 12-week intervention (observation))
- IL-6 at baseline(At baseline, within 7 days before the intervention (observation) starts)