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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Sarcopenia
• Intervention / Treatment: Behavioral: incentive spirometry

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).

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yushan Hsieh, PhD; Phone Number: +886 0228227101; Email: yushan@ntunhs.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type 2 diabetes combined with sarcopenia; incentive spirometry intervention	Behavioral: 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.
No Intervention: Type 2 diabetes combined with sarcopenia control; Routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function: FVC	Forced Vital Capacity (FVC)	3 months
Lung function:FEV1	Forced Expiratory Volume in the First Second (FEV1)	3 months
Lung function: FEV1/FVC ratio	FEV1/FVC ratio	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Metabolic Indicators: HbA1c	Glycated Hemoglobin (HbA1c)	3 months
Long-term Metabolic Indicators: TG	Serum Triglycerides (TG)	3 months
Long-term Metabolic Indicators: LDL	Serum Low-Density Lipoprotein (LDL)	3 months
Long-term Metabolic Indicators: HDL	Serum High-Density Lipoprotein (HDL)	3 months
Long-term Metabolic Indicators: TC	Serum Total Cholesterol (TC)	3 months

Collaborators and Investigators

• Sponsor: Yu-Shan Hsieh

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: lung function; Type 2 diabetes; sarcopenia; incentive spirometer
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Diabetes Mellitus; Diabetes Mellitus, Type 2; Sarcopenia
• Other Study ID Numbers: N202404019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No