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Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes

2010年5月3日 更新者:Universita di Verona

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

The purpose of the study is to evaluate the impact of an exercise programme organized into supervised walking groups on metabolic control, functional capacity and overall quantity of physical activity in subjects with type 2 diabetes.

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

介入性

注册 (实际的)

59

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年3月1日

初级完成 (实际的)

2008年1月1日

研究完成 (实际的)

2009年1月1日

研究注册日期

首次提交

2010年4月26日

首先提交符合 QC 标准的

2010年4月29日

首次发布 (估计)

2010年5月4日

研究记录更新

最后更新发布 (估计)

2010年5月5日

上次提交的符合 QC 标准的更新

2010年5月3日

最后验证

2010年5月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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