The Effects of Individualized Respiratory Exercise Device in Healthy Individuals

Not Applicable

Recruiting

• Conditions: Healthy

• Registration Number: NCT06245928
• Lead Sponsor: Biruni University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximal Inspiratory Pressure (MIP)	8 weeks	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.
Forced Vital Capacity (FVC)	8 weeks	Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Flow 25-75% (FEF25-75)	8 weeks	Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
Maximal Expiratory Pressure (MEP)	8 weeks	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.
Peak Expiratory Flow (PEF)	8 weeks	Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Volume in 1 second (FEV1)	8 weeks	Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
Spiropalm 6-minute Walk Test	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Convenience of Device Use	8 weeks	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".

Trial Locations

Locations (1)

Biruni University; 🇹🇷 Istanbul, Turkey