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临床试验/NCT06500221
NCT06500221尚未招募不适用

Breathing New Life: The Impact of Incentive Spirometer Training on Rehabilitation and Health in Type 2 Diabetes With Sarcopenia

Yu-Shan Hsieh0 个研究点目标入组 45 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
Yu-Shan Hsieh
入组人数
45
主要终点
Lung function:FEV1

研究概览

简要总结

In patients with Type 2 diabetes, the risk of developing sarcopenia is three times higher compared to individuals with normal blood sugar levels. Sarcopenia is often accompanied by reduced physical activity, immobility, slow gait, and poor endurance. More importantly, previous studies have shown that sarcopenia leads to a decrease in mobility, which in turn results in reduced cardiopulmonary function, difficulty in breathing, and subsequently even less activity. In diabetic patients, this can cause poor control of blood sugar and lipids, as well as sarcopenic obesity, creating a vicious cycle. Therefore, preventing such a cycle is a crucial issue that needs attention. The incentive spirometer is widely used in physical, speech, and respiratory therapy, as well as in preventing postoperative pulmonary infections and improving sputum clearance. Consequently, this study aims to further confirm the role and effectiveness of incentive spirometry in improving lung function, activity endurance, and long-term blood sugar and lipid indices in patients with Type 2 diabetes combined with sarcopenia.

详细描述

In patients with Type 2 diabetes, the risk of developing sarcopenia is three times higher compared to individuals with normal blood sugar levels. Sarcopenia is often accompanied by reduced physical activity, immobility, slow gait, and poor endurance. More importantly, previous studies have shown that sarcopenia leads to a decrease in mobility, which in turn results in reduced cardiopulmonary function, difficulty in breathing, and subsequently even less activity. In diabetic patients, this can cause poor control of blood sugar and lipids, as well as sarcopenic obesity, creating a vicious cycle. Therefore, preventing such a cycle is a crucial issue that needs attention. The incentive spirometer is widely used in physical, speech, and respiratory therapy, as well as in preventing postoperative pulmonary infections and improving sputum clearance. Consequently, this study aims to further confirm the role and effectiveness of incentive spirometry in improving lung function, activity endurance, and long-term blood sugar and lipid indices in patients with Type 2 diabetes combined with sarcopenia.

The inclusion criteria:

  1. Diagnosed with Type 2 diabetes (ICD-10 diagnosis codes: E10.x or E11.x)
  2. Screened with a score of 4 or above on the screening self-administered sarcopenia (SARC-F) questionnaire.
  3. Aged between 20-90 years old and able to communicate in Mandarin or Taiwanese

The exclusion criteria:

  1. Patients with a functional status grade of ≥5 on the Modified Rankin Scale (MRS), indicating severe disability or bedridden condition.
  2. Patients suffering from dementia, such as Alzheimer's disease, Parkinson's disease, etc.
  3. Patients with acute psychiatric symptoms unable to communicate.
  4. Currently diagnosed with chronic obstructive pulmonary disease (COPD) or any other respiratory system diseases.
  5. Moderate or severe heart disease (New York Heart Association functional classification Class III or IV).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Type 2 diabetes (ICD-10 diagnosis codes: E10.x or E11.x)
  • Screened with a score of 4 or above on the SARC-F questionnaire.
  • Aged between 20-90 years old and able to communicate in Mandarin or Taiwanese

排除标准

  • Patients with a functional status grade of ≥5 on the Modified Rankin Scale (MRS), indicating severe disability or bedridden condition.
  • Patients suffering from dementia, such as Alzheimer's disease, Parkinson's disease, etc.
  • Patients with acute psychiatric symptoms unable to communicate.
  • Currently diagnosed with chronic obstructive pulmonary disease (COPD) or any other respiratory system diseases.
  • Moderate or severe heart disease (New York Heart Association functional classification Class III or IV).

结局指标

主要结局

Lung function:FEV1

时间窗: 3 months

Forced Expiratory Volume in the First Second (FEV1)

Lung function: FEV1/FVC ratio

时间窗: 3 months

FEV1/FVC ratio

Lung function: FVC

时间窗: 3 months

Forced Vital Capacity (FVC)

次要结局

  • Long-term Metabolic Indicators: TG(3 months)
  • Long-term Metabolic Indicators: HbA1c(3 months)
  • Long-term Metabolic Indicators: TC(3 months)
  • Long-term Metabolic Indicators: HDL(3 months)
  • Long-term Metabolic Indicators: LDL(3 months)

研究者

发起方
Yu-Shan Hsieh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yu-Shan Hsieh

Associate professor

National Taipei University of Nursing and Health Sciences

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