Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT06245928
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2024-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Individualized Respiratory Exercise Device in Healthy Individuals
Sponsor:
Biruni University
Organization:
Study Overview
Official Title:
Development of an Individualized Respiratory Exercise Device Originated in Turkey and Investigation of Its Clinical Effects on Healthy Individuals
Status:
COMPLETED
Status Verified Date:
2025-12
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:
Respiratory exercise devices can be grouped as respiratory muscle training (RMT) devices and incentive spirometers (IS). IS can improve pulmonary ventilation using visual feedback but cannot increase respiratory muscle strength. RMT devices strengthen the respiratory muscles by their resistance mechanisms but they cannot provide visual feedback. It has been stated that RMT increases exercise performance in healthy individuals. RMT devices usually allow only one of inspiratory muscle training or expiratory muscle training. The need to acquire 2 devices for combined training increases the cost. It is seen that the RMT devices available in Turkey do not allow combined training and a significant part of them do not offer sufficient loading range.
The aims of the project are; to develop a multifunctional individualized respiratory exercise device originating in Turkey, and to analyze the clinical effects of an individualized respiratory exercise device on pulmonary function, respiratory muscle strength, and functional capacity in healthy individuals. The device to be developed in this project will be the first multifunctional respiratory exercise device originated in Turkey. The device will have the clinical features of IS and RMT devices and can be individualized according to the desired purpose. With the same device, the individual will be able to both improve the ventilation of the lungs like the IS and strengthen the respiratory muscles in the direction of inspiration and/or expiration with wide loading intervals.
A total of 46 healthy individuals will be included in the study. The healthy individuals included in the study will be randomly divided into two groups experimental group (n=23) and control group (n=23). The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. In both groups, pulmonary function, respiratory muscle strength, and functional capacity will be assessed before and after the 8 weeks of training.
The aims of the project are; to develop a multifunctional individualized respiratory exercise device originating in Turkey, and to analyze the clinical effects of an individualized respiratory exercise device on pulmonary function, respiratory muscle strength, and functional capacity in healthy individuals. The device to be developed in this project will be the first multifunctional respiratory exercise device originated in Turkey. The device will have the clinical features of IS and RMT devices and can be individualized according to the desired purpose. With the same device, the individual will be able to both improve the ventilation of the lungs like the IS and strengthen the respiratory muscles in the direction of inspiration and/or expiration with wide loading intervals.
A total of 46 healthy individuals will be included in the study. The healthy individuals included in the study will be randomly divided into two groups experimental group (n=23) and control group (n=23). The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. In both groups, pulmonary function, respiratory muscle strength, and functional capacity will be assessed before and after the 8 weeks of training.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: