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NCT Number: NCT06500221

Incentive Spirometer Training in Type 2 Diabetes With Sarcopenia

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.

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Key information

About this study

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:

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

The exclusion criteria:

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Incentive spirometry

Behavioral

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.

Primary outcomes

  1. Lung function: FVC

    Time frame: 3 months

    Forced Vital Capacity (FVC)

  2. Lung function:FEV1

    Time frame: 3 months

    Forced Expiratory Volume in the First Second (FEV1)

  3. Lung function: FEV1/FVC ratio

    Time frame: 3 months

    FEV1/FVC ratio

Secondary outcomes

  1. Long-term Metabolic Indicators: HbA1c

    Time frame: 3 months

    Glycated Hemoglobin (HbA1c)

  2. Long-term Metabolic Indicators: TG

    Time frame: 3 months

    Serum Triglycerides (TG)

  3. Long-term Metabolic Indicators: LDL

    Time frame: 3 months

    Serum Low-Density Lipoprotein (LDL)

  4. Long-term Metabolic Indicators: HDL

    Time frame: 3 months

    Serum High-Density Lipoprotein (HDL)

  5. Long-term Metabolic Indicators: TC

    Time frame: 3 months

    Serum Total Cholesterol (TC)

Study contacts

Contact information is provided by the study sponsor or research team.

Yushan Hsieh, PhD

CONTACT

[email protected]

+886 0228227101

Sponsors and collaborators

Lead sponsor

Yu-Shan Hsieh

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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