N/A
N=15
Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB)
Exercise Induced Bronchospasm · Exercise Induced Asthma
Bottom Line
View on ClinicalTrials.gov: NCT06336681 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Exercise-Induced Bronchoconstriction (EIB) Severity — 19.84; 10.94 Percentage (%) — p=0.339
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PrO2Fit Device (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise-Induced Bronchoconstriction (EIB) Severity |
19.84; 10.94 | 0.339 |
| PRIMARY Maximum Inspiratory Pressure |
131.9; 122.4 | 0.495 |
| PRIMARY Sustained Maximum Inspiratory Pressure |
978.4; 978.8 | 0.073 |
| PRIMARY 16-km Cycling Time-Trial Time to Completion |
1900; 1668 | 0.781 |
| PRIMARY 16-km Cycling Time-Trial Power Output |
171.9; 221.8 | 0.769 |
| PRIMARY Constant Load 1 and 2 Speed |
26.6; 35.9; 25.8; 33.4 | 0.639 |
| SECONDARY Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1 |
3.75; 3.94; 2.86; 3.25; 3.25; 3.06 | 0.620 |
| SECONDARY Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2 |
5.71; 7.06; 4.79; 5.17; 5.13; 6.19 | 0.250 |
| SECONDARY Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling |
4.89; 5.75; 4.71; 5.38; 4.50; 5.25 | 0.713 |
| SECONDARY Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 1 |
5.50; 7.57; 8.29; 13.62; 6.19; 6.44 | 0.280 |
| SECONDARY Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 2 |
9.07; 17.49; 10.58; 15.97; 7.93; 12.19 | 0.254 |
| SECONDARY Deoxygenation of the Respiratory and Limb Locomotor Muscles During Time-Trial Cycling |
10.58; 14.19; 10.89; 13.25; 6.40; 14.25 | 0.762 |
| SECONDARY Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 1 |
9384.32; 9055.95; 10255.24; 11687.37 | 0.713 |
| SECONDARY Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 2 |
14970.14; 13760.42; 8608.25; 15903.34 | 0.163 |
Summary
Due to the lack of studies examining the impact of inspiratory muscle training (IMT) on the severity of exercise-induced bronchoconstriction (EIB) and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, short-acting beta-2-agonist medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, exertional dyspnea, and cycling time-trial performance.
Eligibility Criteria
Inclusion Criteria
- Male and female, between the ages of 18 to 35 years.
- Required to be a competitive recreational or college athlete and have at least 1-2 years of cycling or biking experience.
- Body Mass Index (BMI) of 18.5 to 28 kg/m^2
- Considered "moderately to highly active" by the International Physical Activity Questionnaire (IPAQ).
- Have clinically treated mild to moderate persistent asthma and/or exercise-induced bronchoconstriction (EIB), with a resting forced expiratory volume in 1 second (FEV1) > 65% of predicted.
- A ≥ 10% drop in FEV1 after eucapnic voluntary hyperpnea (EVH).
- Prescribed short-acting β2-agonists (SABAs) by a physician.
- Comfortable not taking SABA before experimental visits.
Exclusion Criteria
- History of smoking or recreational smoking, cardiovascular disease, renal disease, neurological disease, and metabolic disease.
- Currently taking asthma maintenance medications (e.g., corticosteroids and leukotriene modifiers)
- Any injuries in the past 6 months.
- Taking selective serotonin reuptake inhibitors (SSRI)'s (antidepressants and anxiety medication), attention-deficit hyperactivity disorder (ADHD) medication, and chronically consume pain medication (Aleve, Tylenol, cannabidiol (CBD), etc.).
- Has had or is positive for COVID-19.
- Resting blood pressure of > 130 mmHg systolic or 90 mmHg diastolic.
- Resting Pulse rate of > 100 bpm.
- Regularly consuming fish oil supplements or eating more then one fish meal per week
Data sourced from ClinicalTrials.gov (NCT06336681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.