Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500221
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-05
Brief Title:
Incentive Spirometer Training in Type 2 Diabetes With Sarcopenia
Sponsor:
Yu-Shan Hsieh
Organization:
National Taipei University of Nursing and Health Sciences
Study Overview
Official Title:
Breathing New Life The Impact of Incentive Spirometer Training on Rehabilitation and Health in Type 2 Diabetes With Sarcopenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 E10x or E11x
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 Alzheimers disease Parkinsons 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
The inclusion criteria
1 Diagnosed with Type 2 diabetes ICD-10 diagnosis codes E10x or E11x
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 Alzheimers disease Parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None