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临床试验/NCT04732611
NCT04732611Unknown不适用

Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus: Randomized Clinical Trial

Federal University of Rio Grande do Sul0 个研究点目标入组 60 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Blood Glycose

研究概览

简要总结

The Diabetes Mellitus (DM) is a major worldwide public health problem. The hyperglycemia resulting from DM could lead to metabolic adaptations and physiological changes in different body systems. The DM patients are usually sedentary, once the symptoms as the sensory deficits compromise balance and gait. Giving that this sedentary lifestyle needs to be reversed, since physical exercise is well known a fundamental element in the treatment and prevention of the DM.

The major recommendations to this population is the practice of aerobic exercises and the strength training focused on the biggest muscle groups. It is well know that this type of exercise can improve the uptake of intramuscular glucose. In that context the Pilates Method seems as a good option of exercise, once the method works in a global way, working on different muscle groups in the same exercise. Besides that, to the best of our knowledge there aren't enough studies to support the Pilates Method as an alternative type exercise to help in the glycemic control and in the management of this kind of patients. The aim of this study is to evaluate the efficacy and safety of an exercise program using the Pilates Method versus a walking program in neuromuscular, metabolic and vascular variables in type 2 diabetic patients.

60 participants will be recruited by convenience. Individuals will be eligible if [1] they had type 2 diabetes mellitus; [2] men and women aged 35 to 60 years [3] medical approval to practice exercise; [4] do not have any bone, joint or muscle disease that make the practice of exercises impossible; [5] not being pregnant; [6] not being unable to follow the instructions for any reason and [7] at least 6 months without exercising. The participants' eligibility will be checked by the researcher. Subsequently, they will be allocated randomly in one of the two groups (Pilates Group or Walking).

Pilates group participants will perform 3 Pilates sessions a week lasting approximately 50 minutes for 20 weeks. Walking group participants will perform 3 walking sessions a week lasting approximately 50 minutes for 20 weeks. All the exercises sessions will be supervised by a professional.

All the participants will be evaluated at the baseline and after 20 weeks of exercises. The main outcome of this study are the Triceps surae muscle force and the blood glycose. The secondary outcomes are Triceps surae muscle architecture, mechanical adaptations of the Achilles tendon and endothelial function.

Our hypothesis is that both groups will be safety and efficiency to improve the Triceps surae muscle force and to decrease blood glycose. Our secondary hypothesis is that the Pilates Group will show better results to both primary outcomes than the walking group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Men and women between 35 and 65 years old;
  • Possess type 2 diabetes mellitus diagnosed;
  • Medical approval to practice exercise;
  • Do not have any bone, joint or muscle disease that make impossible do the exercises;
  • not being pregnant;
  • not being unable to follow the instructions for any reason;
  • not be exercising for at least 6 months.

排除标准

  • Incapacity to follow the instructions for any reason;
  • Beginning another treatment for DM2, either physical therapy, exercises or changes of the medical care throughout the study period.
  • Having practiced exercises in the last six months;
  • Pregnancy;

结局指标

主要结局

Blood Glycose

时间窗: 20 weeks

Blood Glycose assessed by HbA1c

Triceps surae muscle force

时间窗: 20 weeks

Triceps surae muscle force assessed by isokinetic dynamometry.

次要结局

  • Triceps surae muscle architecture(20 weeks)
  • Mechanical adaptations of the Achilles tendon(20 weeks)
  • Endothelial function(20 weeks)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jefferson Fagundes Loss

Professor

Federal University of Rio Grande do Sul

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