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Incentive Spirometer Training in Type 2 Diabetes With Sarcopenia

Y

Yu-Shan Hsieh

Status

Not yet enrolling

Conditions

Type 2 Diabetes
Sarcopenia

Treatments

Behavioral: incentive spirometry

Study type

Interventional

Funder types

Other

Identifiers

NCT06500221
N202404019

Details and patient eligibility

About

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.

Full 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).

Enrollment

45 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 2 patient groups

Type 2 diabetes combined with sarcopenia
Experimental group
Description:
incentive spirometry intervention
Treatment:
Behavioral: incentive spirometry
Type 2 diabetes combined with sarcopenia control
No Intervention group
Description:
Routine care.

Trial contacts and locations

0

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Central trial contact

Yushan Hsieh, PhD

Data sourced from clinicaltrials.gov

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