Effect of Low Volume High Intensity Interval Versus Moderate Intensity Continuous Training on Microalbuminurea in Patients With Diabetic Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- albumin/creatinine ratio
研究概览
简要总结
purpose: to investigate the effect of low-volume high-intensity interval training and moderate- intensity continuous training on microalbuminuria in patients with diabetic nephropathy. methods: forty patients with microalbuminurea will be recruited and randomly assigned to two groups, group A and group B. patients in group A will receive low-volume HIIT and patients in group B will receive MICT. All patients will be evaluated pre and post treatment for laboratory investigation for ( HBa1c, ACR),and blood pressure.
详细描述
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procedures for evaluation: the practical part of the study will be undertaken in 12 weeks(3 sessions a week).measurement will be taken before the start of treatment program then after the end of 12 weeks treatment program in the following manner:
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Anthropometric measures: body mass index (BMI) in kg/m2, waist circumference.
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Blood pressure measurement: Systolic and diastolic blood pressure.
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Biochemical (Lab) analysis:HbA1c, Urinary albumin test (Albumin/Creatinine ratio).
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Treadmill Graded exercise test:(Modified Bruce protocol) It will be used before starting of exercise sessions to determine maximum heart rate reached during this test and to predict individualized training target heart rate and training intensity for each patient before training.
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Treatment procedures: All subjects in the exercise groups A&B will perform the exercise interventions using a treadmill 3 sessions per week for 12 weeks. In the early beginning, patients in all groups will receive an educational session about dietary guidelines for type 2 diabetes.
Group (A): low-volume High Intensity Interval Training Patients in this group will undergo a warm-up at low intensity for 10 minutes, and then they will perform a single bout protocol that consisted of 1×4 min at 80-90% HRmax. Finally, a 5-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.
Group (B): Moderate Intensity Continuous Training Each session will start with a 10-minute warm-up at low intensity. Then they will walk on a treadmill for 30 min at moderate intensity corresponding to 65-75% of HR-max. Finally, a 5-min cool-down period will be permitted.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
quadruple (participant, care provider, investigator, outcome assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II diabetes mellitus
- •Age between 40 to 55 years old.
- •Blood pressure less than or equals 160/100 mmHg.
- •Patients receiving oral hypoglycemic.
- •Increased urinary albumin excretion (UAE)in the absence of other renal diseases.
- •Microalbuminuria (UAE >30µg /min and <299µg /min)
排除标准
- •Patients with Cardiac diseases.
- •Patients with chest diseases (Bronchial asthma and chronic obstructive pulmonary disease).
- •Patients with severe self-limiting illness(cancer).
- •Musculoskeletal or neurological limitations to physical exercise.
- •Patients using insulin therapy.
- •Patients with poorly controlled DM (HbA1c > 9%).
- •Systolic Blood pressure more than 160 mmHg.
- •Morbid obesity.
- •Severe neuropathy.
- •PAD (claudication).
- •Retinopathy (moderate /advanced).
结局指标
主要结局
albumin/creatinine ratio
时间窗: change in 12 weeks
Random urine samples will be collected from patients before and after the end of treatment sessions for measuring al/Cr ratio
Glycated hemoglobin
时间窗: change in 12 weeks
blood samples will be collected from patients before and after the end of treatment sessions for measuring HBA1C
次要结局
- blood pressure(change in 12 weeks)
研究者
Nourhan Mohamed Ali Hussein
Demonstrator
Cairo University