Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
Assessment of Feasibility and Efficacy of a Project Aimed to Improve Metabolic Control in Type 2 Diabetes Through Lifestyle Changes and Self-monitoring of Blood Glucose
研究概览
详细说明
Regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with type 2 diabetes. In addition, these programmes may favourably affect several other cardiovascular risk factors in these subjects. However, it still remains unclear how this evidence can be transferred into clinical practice, considering the very large number of diabetic patients and the characteristics of this population, made up predominantly of elderly, sedentary and overweight patients. In this regard, a realistic approach to this issue requires simple and easily available intervention models.
Walking is a typical mild-moderate aerobic physical activity which is easy to organize and does not require specific skills or preliminary sophisticated medical evaluations. This activity could therefore fit well with the need of involvement of large numbers of patients in different logistic situations. However, it has been reported that, due to the low walking speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a significant metabolic improvement in these subjects.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- diabetes known for at least 2 yr
- physical inactivity
- haemoglobin (Hb)A1c between 6.5-9.9%
- treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection
- willingness to participate in a programme of regular physical activity
Exclusion Criteria:
- moderate-severe autonomic or somatic neuropathy
- severe lower limb vasculopathy
- pre-proliferative or proliferative active retinopathy
- moderate to severe chronic renal failure
- unstable angina or recent (in the previous 3 months) myocardial infarction
- acute intercurrent diseases
- acute metabolic decompensation (blood glucose >300 mg/dl or ketonuria in two consecutive checks)
- use of beta-blocker drugs
- subjects unable to complete a 6-min walk test
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Supervised walking groups
Patients included in walking groups, under the supervision of a qualified personal trainer.
|
Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.
|
|
有源比较器:Controls
Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.
|
Verbal and written information about the benefits of exercise and instructions aimed to encourage physical activity.
In addition, one group session of counselling on these issues.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in haemoglobin A1c (HbA1c) levels
大体时间:4 months
|
The measurement of HbA1c is carried out with a DCCT-aligned method.
|
4 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Body weight
大体时间:4 months
|
4 months
|
|
|
Change in Fasting plasma glucose levels
大体时间:4 months
|
4 months
|
|
|
Change in Total Cholesterol levels
大体时间:4 months
|
4 months
|
|
|
Change in HDL Cholesterol levels
大体时间:4 months
|
4 months
|
|
|
Change in LDL Cholesterol levels
大体时间:4 months
|
4 months
|
|
|
Change in Triglycerides levels
大体时间:4 months
|
4 months
|
|
|
Change in Blood Pressure
大体时间:4 months
|
4 months
|
|
|
6分钟步行距离变化
大体时间:4个月
|
该测试测量在 30 米的路线上 6 分钟内可以步行的米数。
这是评估有氧功能能力的简单现场测试。
|
4个月
|
|
Change in C-reactive protein levels
大体时间:4 months
|
4 months
|
|
|
Change in Energy expenditure through voluntary physical activity
大体时间:4 months
|
Energy expenditure is estimated through 7-day activity diaries.
The intensity of each activity (defined in metabolic equivalents, MET) is multiplied by duration and the product for each activity is summed to give a total activity score in MET hours/week.
|
4 months
|
|
Change in Antidiabetic medications
大体时间:4 months
|
Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol, to assess changes in hypoglycemic medication during the trial.
|
4 months
|
|
Compliance with walking sessions
大体时间:4 months
|
Attendance at the scheduled walking sessions is recorded for each patient.
|
4 months
|
合作者和调查者
调查人员
- 首席研究员:Paolo Moghetti, M.D., Ph.D.、Universita di Verona
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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