Incentive Spirometer Training in Type 2 Diabetes With Sarcopenia

NCT06500221 | Not Yet Recruiting DMC

• 1 other identifier: N202404019
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes; Sarcopenia

Keywords

Type 2 diabetes; sarcopenia; incentive spirometer; lung function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Long-term Metabolic Indicators: HbA1c

  3 months

• Long-term Metabolic Indicators: TG

  3 months

• Long-term Metabolic Indicators: LDL

  3 months

• Long-term Metabolic Indicators: HDL

  3 months

• Long-term Metabolic Indicators: TC

  3 months

Study Arms (2)

Type 2 diabetes combined with sarcopenia

EXPERIMENTAL

incentive spirometry intervention

Behavioral: incentive spirometry

Type 2 diabetes combined with sarcopenia control

NO INTERVENTION

Routine care.

Interventions

incentive spirometry 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

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yu-Shan Hsieh: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sarcopenia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Yushan Hsieh, PhD

CONTACT

+886 0228227101; yushan@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: patients with Type 2 diabetes combined with sarcopenia.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 15, 2024
• Study Start: August 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share