The Effects of Individualized Respiratory Exercise Device in Healthy Individuals

December 7, 2025 updated by: Hikmet Ucgun, Biruni University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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.
Device: Individualized Respiratory Exercise Device
The Individualized Respiratory Exercise device will include both inspiratory muscle training, expiratory muscle training, and intensive spirometer features.
Active Comparator: Control Group
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.
Device: Threshold® IMT + Threshold™ PEP
The Threshold® IMT device allows inspiratory muscle training and the Threshold™ PEP device allows expiratory muscle training.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Convenience of Device Use
Time Frame: 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".
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Collaborators

The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • buhucgun04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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