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NCT Number: NCT07528222

Effect of Digital Incentive Spirometry Training in Healthy Adults

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.

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Key information

Conditions

Respiratory Function Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Function Respiration Disorders Respiratory Aspiration Respiratory Muscle Strength Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University, Taipei, Taiwan

Taipei, 11031, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TryBreath Digital Incentive Spirometry System

Device

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.

Primary outcomes

  1. 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.

  2. Change from baseline in Forced Vital Capacity (FVC)

    Time frame: Baseline and post-intervention at 3 weeks

    FVC measured before and after the intervention.

  3. Change from baseline in Peak Expiratory Flow (PEF)

    Time frame: Baseline and post-intervention at 3 weeks

    PEF measured before and after the intervention.

Secondary outcomes

  1. Change from baseline in Maximal Inspiratory Pressure (MIP)

    Time frame: Baseline and post-intervention at 3 weeks

    MIP measured before and after the intervention.

  2. Change from baseline in Maximal Expiratory Pressure (MEP)

    Time frame: Baseline and post-intervention at 3 weeks

    MEP measured before and after the intervention.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 14, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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