EFFECT OF HIGH VERSUS LOW-VOLUME HIGH INTENSITY INTERVAL TRAINING ON GLYCEMIC AND LIPIDS CONTROL IN TYPE 2 DIABETES
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- fasting & 2-h post prandial blood glucose
研究概览
简要总结
Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes. The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however, little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid control in these patients. Therefore, the purpose of this study is to compare between two subtypes of HIIT (i.e. the low-volume HIIT versus the high-volume HIIT) with respect to exercise-induced changes in blood glucose, lipid profile and anthropometry in patients with type 2 diabetes mellitus. Statement of the Problem Is there any difference between the effect of high-volume and the low-volume high intensity interval training on glycemic and lipids control in type 2 diabetes?
Purpose of the study:
To assess the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.
Null Hypothesis:
There will be no difference between the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.
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
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Type II diabetes mellitus diagnosed by a physician as having HbA 1c of > 6.5%.
- •An established diagnosis of T2DM for at least 1year and less than 5 years.
- •Women patients.
- •Age between 35 to 45 years old.
- •Systolic Blood pressure less than or equal 130 mmHg.
- •Obese patients (BMI is between 30 and 39.9 kg/m 2 )
- •Patients with HbA 1c of 7-9%.
- •A self-reported sedentary lifestyle.
- •Patients receiving oral hypoglycemic medications described by the physician
- •Patients with hyperlipidemia.
排除标准
- •Patients with Cardiac diseases.
- •Patients with glaucoma.
- •Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).
- •Musculoskeletal or neurological limitations to physical exercise.
- •Patients under insulin therapy
- •Patients with poorly controlled DM (HbA1c > 9%)
- •Bronchial asthma and chronic obstructive pulmonary disease.
- •Morbidly obese BMI ≥ 40 kg/m 2
- •Systolic Blood pressure more than 130 mmHg.
- •Anemia ( hemoglobin < 12 g/dL)
- •Osteopenia.
研究组 & 干预措施
Group (A): The high-volume HIIT
Exercise group A (n=30): It will include patients that will perform high-volume high-intensity interval training (HIIT), and will receive medical intervention.
干预措施: The high-volume HIIT (Other)
Group (B): The low-volume HIIT
Exercise group B (n=30): will receive medical intervention. that will perform the low-volume high-intensity interval training, and will receive medical intervention.
干预措施: The low-volume HIIT (Other)
Group C
patients will receive medical intervention only.
结局指标
主要结局
fasting & 2-h post prandial blood glucose
时间窗: 12 weeks
change in fasting \& 2-h post prandial blood glucose
body mass index
时间窗: 12 weeks
change in body mass index
waist circumference
时间窗: 12 weeks
change in waist circumference
waist/hip ratio
时间窗: 12 weeks
change in waist/hip ratio
Systolic and diastolic blood pressure
时间窗: 12 weeks
change in Systolic and diastolic blood pressure
HbA1c
时间窗: 12 weeks
change in HbA1c
fasting lipid profile
时间窗: 12 weeks
change in fasting lipid profile
次要结局
未报告次要终点
研究者
Asmaa Mohamed Mahmoud Mohamed
physiotherapist holds a master's degree in Physical therapy for Cardiovascular, Respiratory disorders and geriatrics, Faculty of physical therapy, Cairo university.
Cairo University