Clinical trial NCT06245928: The Effects of Individualized Respiratory Exercise Device in Healthy Individuals
Official title: Development of an Individualized Respiratory Exercise Device Originated in Turkey and Investigation of Its Clinical Effects on Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Respiratory Exercise Device
Biomedical Device
Pulmonary Function
Respiratory Muscle Strength
Functional Capacity
Respiratory Muscle Training
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-02-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: 8 weeks
measure: Maximal Expiratory Pressure (MEP)
timeFrame: 8 weeks
measure: Forced Vital Capacity (FVC)
timeFrame: 8 weeks
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 8 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: 8 weeks
measure: Forced Expiratory Flow 25-75% (FEF25-75)
timeFrame: 8 weeks
measure: Spiropalm 6-minute Walk Test
timeFrame: 8 weeks
Secondary outcomes:
measure: Convenience of Device Use
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References: