The Effects of Individualized Respiratory Exercise Device in Healthy Individuals

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Description

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.

Targeted Conditions

Study Overview

Start Date
January 1, 2024
Completion Date
May 30, 2025
Enrollment
46
Date Posted
February 7, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Biruni University
Istanbul, Turkey

Eligibility

Minimum Age (years)
18
Maximum Age (years)
65
Eligibility Criteria
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 Contact Info

Study Contact Name
Hikmet Ucgun, PT, PhD; Buket Akıncı, PT, PhD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06245928