The Effects of Individualized Respiratory Exercise Device in Healthy Individuals

Biruni University

Status: Completed

Conditions: Healthy

Treatments: Device: Threshold® IMT + Threshold™ PEP; Device: Individualized Respiratory Exercise Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06245928

buhucgun04

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Experimental Group

Experimental group

Description:

The individuals in the experimental group will be trained with an individualized respiratory exercise device for 5 days a week for 8 weeks. The initial pressure load will be set to the resistance level corresponding to 40% of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements. Participants will be asked to rest following 6 breathing cycles and repeat a total of 36 breathing cycles (6 sets) in each session. Participants will be able to practice both inspiratory and expiratory respiratory muscle training in one breathing cycle. Progression will be increased by 5-10% weekly, with the perceived exertion level being in the range of 4-6 according to the Modified Borg Scale. In addition, physical activity will be recommended.

Treatment:

Device: Individualized Respiratory Exercise Device

Control Group

Active Comparator group

Description:

The individuals in the control group will be trained with Threshold® IMT + Threshold™ PEP training for 5 days a week for 8 weeks. Respiratory muscle training will be performed with Threshold® IMT and Threshold™ PEP devices. The training intensity will be set to 40% of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements in the first week. Participants will be asked to perform 6 sets of 6 repetitions for inspiratory and expiratory muscle training separately for a total of 36 repetitions each. Progression will be increased by 5-10% weekly so that the perceived exertion level will be in the range of 4-6 according to the Modified Borg Scale. If the training threshold exceeds the upper-pressure limits of the Threshold® IMT + Threshold™ PEP devices, the training intensity will be continued at the highest limit. In addition, physical activity will be recommended.

Treatment:

Device: Threshold® IMT + Threshold™ PEP