Incentive Spirometer Training in Type 2 Diabetes With Sarcopenia

NCT ID: NCT06500221

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-02-28

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).

Conditions

Type 2 Diabetes; Sarcopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Type 2 diabetes combined with sarcopenia

incentive spirometry intervention

Group Type: EXPERIMENTAL

incentive spirometry

Intervention Type: 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.

Type 2 diabetes combined with sarcopenia control

Routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

incentive 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.

Intervention Type: BEHAVIORAL

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'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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yu-Shan Hsieh

OTHER

Sponsor Role: lead

Responsible Party

Yu-Shan Hsieh

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Yushan Hsieh, PhD

Role: CONTACT

yushan@ntunhs.edu.tw

+886 0228227101

Other Identifiers

N202404019

Identifier Type: -

Identifier Source: org_study_id