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Effect of Digital Incentive Spirometry Training in Healthy Adults

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07528222
Enrollment
30
Registered
2026-04-14
Start date
2024-05-22
Completion date
2025-01-09
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Function, Respiratory Function, Respiratory Muscle Strength

Keywords

Incentive Spirometry, Digital Incentive Spirometry, Respiratory Training, Pulmonary Function, Healthy Adults, TryBreath, Mobile Health, Telemonitoring

Brief summary

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.

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.

Interventions

DEVICETryBreath 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.

Sponsors

Taipei Medical University
Lead SponsorOTHER
National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

All participants received the same digital incentive spirometry intervention and were evaluated before and after the intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in forced expiratory volume in 1 second (FEV1)Baseline and post-intervention at 3 weeksFEV1 measured before and after the intervention.
Change from baseline in Forced Vital Capacity (FVC)Baseline and post-intervention at 3 weeksFVC measured before and after the intervention.
Change from baseline in Peak Expiratory Flow (PEF)Baseline and post-intervention at 3 weeksPEF measured before and after the intervention.

Secondary

MeasureTime frameDescription
Change from baseline in Maximal Inspiratory Pressure (MIP)Baseline and post-intervention at 3 weeksMIP measured before and after the intervention.
Change from baseline in Maximal Expiratory Pressure (MEP)Baseline and post-intervention at 3 weeksMEP measured before and after the intervention.
Change from baseline in 2-Minute Step Test PerformanceBaseline and post-intervention at 3 weeksDifference in 2-Minute Step Test Performance between baseline and post-intervention assessment.
Change from baseline in Borg Dyspnea Scale score.Baseline and post-intervention at 3 weeksDifference 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.
Change from baseline in Numeric Rating Scale (NRS) for muscle discomfort.Baseline and post-intervention at 3 weeksDifference 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026