The Effects of Individualized Respiratory Exercise Device in Healthy Individuals

Healthy Clinical Trial

Official title:

Development of an Individualized Respiratory Exercise Device Originated in Turkey and Investigation of Its Clinical Effects on Healthy Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245928
• Other study ID #: buhucgun04
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: January 2024
• Source: Biruni University
• Contact: Hikmet Ucgun, PT, PhD
• Phone: +905321616271
• Email: hikmetucgun92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: May 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18-65

• Answering "No" to the general health questions of the Exercise Readiness Questionnaire for all

Exclusion Criteria:

• Being an amateur or professional athlete who does sports-specific training at least 2 times a week

• Having a chronic disease

• Having history of spontaneous or trauma-related pneumothorax

• Having pathologies related to the middle ear (such as tympanic membrane rupture, otitis)

• Receiving routine medical treatment other than vitamin supplements for any reason

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Individualized Respiratory Exercise Device
The Individualized Respiratory Exercise device will include both inspiratory muscle training, expiratory muscle training, and intensive spirometer features.
• Threshold® IMT + Threshold™ PEP
The Threshold® IMT device allows inspiratory muscle training and the Threshold™ PEP device allows expiratory muscle training.

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Biruni University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Inspiratory Pressure (MIP)	Maximal Inspiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.	8 weeks
Primary	Maximal Expiratory Pressure (MEP)	Maximal Expiratory Pressure will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.	8 weeks
Primary	Forced Vital Capacity (FVC)	Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.	8 weeks
Primary	Forced Expiratory Volume in 1 second (FEV1)	Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.	8 weeks
Primary	Peak Expiratory Flow (PEF)	Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.	8 weeks
Primary	Forced Expiratory Flow 25-75% (FEF25-75)	Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.	8 weeks
Primary	Spiropalm 6-minute Walk Test	The 6-minute Walk Test will be performed with Spiropalm 6 DYT (Cosmed, Spiropalm 6MWT) according to ATS guidelines. Walking distance, minute ventilation, respiratory rate, inspiratory capacity and breathing reserve will be recorded.	8 weeks
Secondary	Convenience of Device Use	A 5-point Likert scale will be used to question the convenience of use of the devices used. Scoring will be determined as 1- "very difficult to use", 5- "very easy to use".	8 weeks