Effect of Digital Incentive Spirometry Training in Healthy Adults

April 14, 2026 updated by: Shu-Chuan Ho, Taipei Medical University

Effect of Digital Incentive Spirometry Training on Pulmonary Function and Respiratory Muscle Strength in Healthy Adults: A Prospective Single-Group Pre-Post Study

This prospective single-group pre-post study evaluated whether digital incentive spirometry training using the TryBreath system could improve pulmonary function, respiratory muscle strength, exercise capacity, and symptom scores in healthy adults. Participants completed a 3-week training period with app-recorded adherence and were assessed before and after the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective single-group pre-post study investigated the effects of digital incentive spirometry training in healthy adults. Participants were recruited at Taipei Medical University and received training using the TryBreath digital incentive spirometry system, which integrates an incentive spirometer with infrared sensing, ultrasonic wireless data transmission, and a mobile application for real-time feedback and adherence tracking.

Participants completed a 3-week intervention period. The target training dose was at least 30 sustained inspirations per day, and at least 10 compliant training days were required for protocol adherence. Pulmonary function, respiratory muscle strength, exercise capacity, and symptom scores were assessed before and after the intervention.

Outcome measures included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), 2-minute step test performance, Borg breathlessness score, and numerical rating scale (NRS) muscle discomfort score.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Taiwan
      • Taipei, Taiwan, 11031
        • Taipei Medical University, Taipei, Taiwan

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults aged 18 to 45 years
  • FEV1/FVC greater than 70% on pulmonary function testing
  • Not currently participating in another research study
  • Able and willing to provide informed consent

Exclusion Criteria:

  • EV1/FVC less than 70% on pulmonary function testing
  • History of thoracic or pulmonary disease, including pneumothorax, lung cancer, or prior thoracic surgery
  • Acute exacerbation of asthma, chronic bronchitis, or chronic obstructive pulmonary disease within the previous 3 months
  • Unable to comply with study procedures

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Incentive Spirometry Training
Participants received digital incentive spirometry training using the TryBreath system during a 3-week intervention period. The target training dose was at least 30 sustained inspirations per day, and adherence was tracked through a mobile application.
Device: TryBreath Digital Incentive Spirometry System
A digital incentive spirometer integrated with infrared sensing and ultrasonic wireless data transmission, connected to a mobile application that records inspiratory training sessions and provides real-time feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in forced expiratory volume in 1 second (FEV1)
Time Frame: Baseline and post-intervention at 3 weeks
FEV1 measured before and after the intervention.
Baseline and post-intervention at 3 weeks
Change from baseline in Forced Vital Capacity (FVC)
Time Frame: Baseline and post-intervention at 3 weeks
FVC measured before and after the intervention.
Baseline and post-intervention at 3 weeks
Change from baseline in Peak Expiratory Flow (PEF)
Time Frame: Baseline and post-intervention at 3 weeks
PEF measured before and after the intervention.
Baseline and post-intervention at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Maximal Inspiratory Pressure (MIP)
Time Frame: Baseline and post-intervention at 3 weeks
MIP measured before and after the intervention.
Baseline and post-intervention at 3 weeks
Change from baseline in Maximal Expiratory Pressure (MEP)
Time Frame: Baseline and post-intervention at 3 weeks
MEP measured before and after the intervention.
Baseline and post-intervention at 3 weeks
Change from baseline in 2-Minute Step Test Performance
Time Frame: Baseline and post-intervention at 3 weeks
Difference in 2-Minute Step Test Performance between baseline and post-intervention assessment.
Baseline and post-intervention at 3 weeks
Change from baseline in Borg Dyspnea Scale score.
Time Frame: Baseline and post-intervention at 3 weeks
Difference in Borg score between baseline and post-intervention assessment. The Borg Dyspnea Scale ranges from 0 to 10, where 0 indicates no breathlessness and 10 indicates maximal breathlessness. Higher scores indicate worse breathlessness.
Baseline and post-intervention at 3 weeks
Change from baseline in Numeric Rating Scale (NRS) for muscle discomfort.
Time Frame: Baseline and post-intervention at 3 weeks
Difference in NRS score between baseline and post-intervention assessment. The NRS ranges from 0 to 10, where 0 indicates no discomfort and 10 indicates worst possible discomfort. Higher scores indicate greater muscle discomfort.
Baseline and post-intervention at 3 weeks

Collaborators and Investigators

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

Sponsor

Taipei Medical University

Collaborators

National Science and Technology Council, Taiwan

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)

May 22, 2024

Primary Completion (Actual)

December 26, 2024

Study Completion (Actual)

January 9, 2025

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202404134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available because the dataset may contain potentially identifiable participant-level information and proprietary device-related records. Deidentified data may be available from the corresponding author upon reasonable request and subject to institutional review and applicable data-sharing regulations.

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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