Clinical trial NCT06500221: Incentive Spirometer Training in Type 2 Diabetes With Sarcopenia
Official title: Breathing New Life: The Impact of Incentive Spirometer Training on Rehabilitation and Health in Type 2 Diabetes With Sarcopenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Sarcopenia
Keywords: Type 2 diabetes
sarcopenia
incentive spirometer
lung function
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: patients with Type 2 diabetes combined with sarcopenia.
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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\&#39;s disease, Parkinson\&#39;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).

Primary outcomes:
measure: Lung function: FVC
timeFrame: 3 months
measure: Lung function:FEV1
timeFrame: 3 months
measure: Lung function: FEV1/FVC ratio
timeFrame: 3 months
Secondary outcomes:
measure: Long-term Metabolic Indicators: HbA1c
timeFrame: 3 months
measure: Long-term Metabolic Indicators: TG
timeFrame: 3 months
measure: Long-term Metabolic Indicators: LDL
timeFrame: 3 months
measure: Long-term Metabolic Indicators: HDL
timeFrame: 3 months
measure: Long-term Metabolic Indicators: TC
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
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