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临床试验/NCT05110092
NCT05110092Unknown不适用

Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers

Taipei Veterans General Hospital, Taiwan0 个研究点目标入组 64 人开始时间: 2016年12月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
64
主要终点
wound healing

研究概览

简要总结

The purpose of the study was designed leg resistance training combined with breathing approach, and evaluated its effect on wound healing, blood sugar control and quality of life in type 2 diabetic patients with foot ulcers.

详细描述

A randomized controlled trial was used. type 2 diabetic patients who suffered from foot ulcers were recruited from one medical center of Northern Taiwan, and randomly assigned into the exercise or control group. The control group received usual care for diabetic foot. The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks. Outcomes were measured by wound healing area, the fasting of blood glucose, hemoglobin A1c (HbA1c), and the World Health Organization quality of life-BREF (WHOQOL-BREF) before the intervention as baseline, and the 4th, 8th and 12th weeks during the intervention period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

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

入选标准

  • patients 20 years or older
  • who were diagnosed with type 2 diabetic foot
  • ulcers of Meggitt-Wagner Grade 1-2
  • who were conscious and could perform the prescribed exercise.

排除标准

  • peripheral arterial occlusion disease
  • osteomyelitis
  • inability to perform exercise as assessed by physicians.

结局指标

主要结局

wound healing

时间窗: during 12 weeks the intervention period.

wound size(cm2)

blood sugar control-fasting blood sugar

时间窗: during 12 weeks the intervention period.

fasting blood sugar(mg/dl ) using a blood glucose meter

quality of life measured by the World Health Organization Quality of Life-BREF

时间窗: during 12 weeks the intervention period.

Quality of life was measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) in the Taiwan version

blood sugar control-HbA1c

时间窗: during 12 weeks the intervention period.

The levels of hemoglobin A1c (%)(HbA1c) were monitored blood sugar in the long term

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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