Effect of Digital Incentive Spirometry Training on Pulmonary Function and Respiratory Muscle Strength in Healthy Adults: A Prospective Single-Group Pre-Post Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Taipei Medical University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from baseline in forced expiratory volume in 1 second (FEV1)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: TryBreath Digital Incentive Spirometry System (Device)
Outcomes
Primary Outcomes
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.
Change from baseline in Forced Vital Capacity (FVC)
Time Frame: Baseline and post-intervention at 3 weeks
FVC measured before and after the intervention.
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
- Change from baseline in Maximal Inspiratory Pressure (MIP)(Baseline and post-intervention at 3 weeks)
- Change from baseline in Maximal Expiratory Pressure (MEP)(Baseline and post-intervention at 3 weeks)
- Change from baseline in 2-Minute Step Test Performance(Baseline and post-intervention at 3 weeks)
- Change from baseline in Borg Breathlessness Score(Baseline and post-intervention at 3 weeks)
- Change from baseline in Muscle Discomfort Score (NRS)(Baseline and post-intervention at 3 weeks)
- Change from baseline in Borg Dyspnea Scale score.(Baseline and post-intervention at 3 weeks)
- Change from baseline in Numeric Rating Scale (NRS) for muscle discomfort.(Baseline and post-intervention at 3 weeks)
Investigators
Shu-Chuan Ho
Professor
Taipei Medical University