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临床试验/NCT03221868
NCT03221868已完成不适用

Effects of a Physical Exercise Program Among Diabetic Women Users of the National Health System: a Randomized Clinical Trial

Federal University of Pelotas2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Change in HbA1c

研究概览

简要总结

The study aims at evaluating the effects of an intervention among diabetic women (40 years or older) who belong to the Basic Health Units System (Brazilian public health system). The novelty of this project is that the intervention is low cost and demands very little from the health system in terms of structure, facilities and personnel.

详细描述

The objective of this project is to evaluate the effect of a physical exercise program on the biochemical profile of type 2 diabetic women users of Basic Health Units (BHU) in the urban area of the city of Pelotas (Brazil). This is a randomized clinical trial, where two BHU's of the 14 eligible for the study will be drawn for inclusion in the study. Only those units with more than 100 registered diabetic patients are eligible, they also are not linked to educational institutions and do not present Physical activity projects. Four Basic Health Units (BHU) of the municipality of Pelotas (Brazil) were randomized, two for the intervention group and two for the control group. The intervention group will perform circuit-like physical exercises three times a week and the control will receive counseling to practice physical activity and meetings every 15 days with the womens to carry out walks. The program lasted 12 weeks, with three weekly sessions and presented four distinct sequences containing 10 exercises each, which were performed and circuit form and modified every three weeks. In the first week of the intervention, the women performed a passage in the circuit and with each new week a passage was increased, until the number of three passes was reached (number of passages kept fixed until the end of the intervention). Each exercise initially had a duration of 30 seconds, with a duration of 10 seconds added every three weeks up to a maximum of 60 seconds; The interval of 30 seconds between exercises was kept fixed throughout the intervention. The intensity was controlled by the subjective perception of effort. Mainly blood chemistry will be measured and evaluated.Possible confounding factors to be controlled: age, skin color, schooling, family income, weight, Body Mass Index (BMI), alcohol consumption, smoking, waist circumference, time to diagnose the disease, use of Medicines for diabetes and eating habits. The information will be collected at the baseline, at the eighth week and at the end of the study. Descriptive analyzes of the data will be performed initially, the associations will be tested by correlation, t-test and ANOVA for repeated measures. For comparisons of categorical variables, Chi-square tests will be used for heterogeneity or linear trend. The multivariate analysis will be run through logistic regression. The analyzes will be performed by intention to treat and by adherence, and the level of significance accepted for the study will be 5%. This study will seek to fill gaps in the knowledge about intervention studies in BHU's in order to identify whether physical exercise interventions with proper planning and orientation can promote improvements in the severity of the disease in diabetic women.

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
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • type 2 diabetic;
  • diagnosed for more than one year;
  • BMI ≥25 kg / m²;
  • age between 40 and 60 years.

排除标准

  • BMI ≥ 40 kg / m²;
  • history of stroke;
  • neuropathy or severe retinopathy;
  • any serious medical condition that prevents the participant to exercise safely;
  • history of severe physical disability
  • history of acute myocardial infarction in the last six months.

研究组 & 干预措施

Physical exercise intervention

Experimental

Exercise group. Physical exercise intervention with sessions carried out as circuit-training, three times a week for 12 weeks to improve physical fitness and metabolic control. The sessions will last between 10 and 45 minutes.

干预措施: Exercise group (Behavioral)

Control

Active Comparator

Control group consisting of women who underwent the same measurements for future comparisons and were assigned to receive information about health and counseling to practice of physical activity.

干预措施: Control group (Behavioral)

结局指标

主要结局

Change in HbA1c

时间窗: Measured at baseline, and the end of intervention, 12th week

- Glycated hemoglobin - %

次要结局

  • Change in Triglycerides(Measured at baseline, and the end of intervention, 12th week)
  • Change in CRP(Measured at baseline, and the end of intervention, 12th week)
  • Change in Glucose(Measured at baseline, and the end of intervention, 12th week)
  • Change in Insulin(Measured at baseline, and the end of intervention, 12th week)
  • Change in LLS(Measured at baseline, and the end of intervention, 12th week)
  • Change in BP(Measured at baseline, and the end of intervention, 12th week)
  • Change in QoL(Measured at baseline, and the end of intervention, 12th week)
  • Change in Insulin resistance(Measured at baseline, and the end of intervention, 12th week)
  • Change in Cholesterol(Measured at baseline, and the end of intervention, 12th week)
  • Change in CRF(Measured at baseline, and the end of intervention, 12th week)

研究者

发起方
Federal University of Pelotas
申办方类型
Other
责任方
Principal Investigator
主要研究者

MARLOS RODRIGUES DOMINGUES

Professor

Federal University of Pelotas

研究点 (2)

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