Analysis of the effectiveness of physical activity protocols on physiological and psychological parameters of patients 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
- 105
- 试验地点
- 1
- 主要终点
- Fasting blood glucose, glycosylated hemoglobin, heart rate, blood pressure, doppler ultrasonography, BMI, Hip waist circumference, BMD, wellbeing, quality of life, Diabetes treatment satisfaction questionnaire
研究概览
简要总结
This study is a randomized control trial to study theeffectiveness of physical activity protocols along with pedometer onphysiological and psychological parameters of patients with type 2 diabetes. Totally105 type 2 diabetics would be recruited and will be divided in to one controland two experimental groups with 35 subjects in each group. Experimental groupincludes supervised exercise with pedometer and self reported exercise groupwith pedometer. Thepedometer reading and the resting heart rate and blood pressure will berecorded for all the sessions. The self reported group will continue with theirexercise protocol each day and record the number of steps walked and follow instructionseach day. After 8 week each subjects will report for follow up and repeatreadings of all parameters to document improvement in health status. They willcontinue their protocols until 16th week where a final reading forall subjects will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Established cases of type 2 diabetes mellitus (at least One year old)
- •Male or Female
- •Age group: 40.
排除标准
- •Fluctuating blood pressure levels and blood glucose Values above 250 mg/dl
- •Significant weight change
- •Significant renal disease
- •Restriction in physical activity due to disease, Intermittent claudication, severe peripheral disease,Unstable cardiac and pulmonary disease, stroke, arthritis
- •Significant cognitive deficits 6.
结局指标
主要结局
Fasting blood glucose, glycosylated hemoglobin, heart rate, blood pressure, doppler ultrasonography, BMI, Hip waist circumference, BMD, wellbeing, quality of life, Diabetes treatment satisfaction questionnaire
时间窗: Sept 2011- 0 week | Nov 2011 8 week | Jan 2011- 16 week
次要结局
未报告次要终点