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Incentive Spirometer Training in Type 2 Diabetes With Sarcopenia

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06500221
Enrollment
45
Registered
2024-07-15
Start date
2024-08-01
Completion date
2025-02-28
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia, Type 2 Diabetes

Keywords

Type 2 diabetes, sarcopenia, incentive spirometer, lung function

Brief summary

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.

Detailed description

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).

Interventions

BEHAVIORALincentive spirometry

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.

Sponsors

Yu-Shan Hsieh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

patients with Type 2 diabetes combined with sarcopenia.

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Lung function: FVC3 monthsForced Vital Capacity (FVC)
Lung function:FEV13 monthsForced Expiratory Volume in the First Second (FEV1)
Lung function: FEV1/FVC ratio3 monthsFEV1/FVC ratio

Secondary

MeasureTime frameDescription
Long-term Metabolic Indicators: HDL3 monthsSerum High-Density Lipoprotein (HDL)
Long-term Metabolic Indicators: HbA1c3 monthsGlycated Hemoglobin (HbA1c)
Long-term Metabolic Indicators: TC3 monthsSerum Total Cholesterol (TC)
Long-term Metabolic Indicators: TG3 monthsSerum Triglycerides (TG)
Long-term Metabolic Indicators: LDL3 monthsSerum Low-Density Lipoprotein (LDL)

Contacts

Primary ContactYushan Hsieh, PhD
yushan@ntunhs.edu.tw+886 0228227101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026